71 Regulatory Submissions jobs in Bahrain
Pharmaceutical Regulatory Affairs Specialist
1015 Northern, Northern
BHD70000 Annually
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Posted today
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Job Description
Our client, a leading pharmaceutical company, is seeking a diligent and knowledgeable Pharmaceutical Regulatory Affairs Specialist to ensure compliance with all relevant regulations and guidelines. This critical role involves navigating the complex regulatory landscape for drug development, approval, and lifecycle management. The ideal candidate will possess a strong understanding of pharmaceutical regulations, excellent analytical skills, and meticulous attention to detail.
Key Responsibilities:
Key Responsibilities:
- Prepare, review, and submit regulatory documentation for new drug applications (NDAs), variations, and renewals to health authorities.
- Maintain a thorough understanding of current and evolving national and international pharmaceutical regulations.
- Liaise with regulatory agencies to facilitate the review and approval process for pharmaceutical products.
- Provide regulatory guidance and support to internal teams, including R&D, manufacturing, and marketing.
- Monitor regulatory intelligence and assess the impact of new regulations on company products and strategies.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant quality standards.
- Manage post-approval regulatory activities, such as annual reports and safety updates.
- Review and approve promotional materials and labeling to ensure regulatory compliance.
- Participate in regulatory audits and inspections.
- Maintain accurate and organized regulatory databases and filing systems.
- Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a related life science field. A Master's degree is advantageous.
- Minimum of 3-5 years of experience in regulatory affairs within the pharmaceutical industry.
- In-depth knowledge of regulatory submission processes and requirements in key markets.
- Familiarity with ICH guidelines and regional regulatory frameworks.
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent written and verbal communication skills, with the ability to draft clear and concise regulatory documents.
- Meticulous attention to detail and a commitment to accuracy.
- Ability to work independently and collaboratively in a fast-paced environment.
- Proficiency in regulatory information management systems is a plus.
- Must be able to work effectively within a hybrid model in **Shakhura, Northern, BH**.
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0
Pharmaceutical Regulatory Affairs Specialist
800 Southern, Southern
BHD85000 Annually
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Posted 5 days ago
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Job Description
Our client, a rapidly growing pharmaceutical company, is seeking a dedicated Pharmaceutical Regulatory Affairs Specialist to join their dynamic team. This role offers the flexibility of being fully remote. You will be responsible for ensuring compliance with regulatory requirements for the development, manufacturing, and marketing of pharmaceutical products. Your duties will include preparing and submitting regulatory dossiers to health authorities, responding to regulatory inquiries, and staying updated on evolving regulatory landscapes and guidelines in key markets. You will play a crucial role in facilitating the timely approval of new drug applications and post-approval variations. The ideal candidate will possess a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field, with a minimum of 5 years of experience in pharmaceutical regulatory affairs. Proven experience in preparing and filing regulatory submissions (e.g., INDs, NDAs, MAAs) with major health authorities (FDA, EMA, etc.) is essential. Strong understanding of pharmaceutical regulations, ICH guidelines, and GMP principles is required. Excellent written and verbal communication skills, meticulous attention to detail, and strong organizational abilities are crucial. The ability to work independently, manage multiple projects, and collaborate effectively with internal teams (R&D, Quality Assurance, Marketing) and external regulatory agencies in a remote setting is paramount. We are looking for a proactive professional committed to ensuring patient access to high-quality medicines through effective regulatory strategies.
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1
Pharmaceutical Regulatory Affairs Manager
80501 Isa Town, Northern
BHD100000 Annually
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Posted 20 days ago
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Job Description
Our client, a dynamic pharmaceutical company, is seeking a seasoned Pharmaceutical Regulatory Affairs Manager to lead and manage all aspects of regulatory submissions and compliance. This is a fully remote position, offering an excellent opportunity to contribute to the launch and lifecycle management of innovative pharmaceutical products. You will be responsible for developing regulatory strategies, preparing and submitting high-quality dossiers to global health authorities (e.g., FDA, EMA, MHRA), and ensuring adherence to all relevant regulations and guidelines. Key duties include interpreting regulatory requirements, advising project teams on regulatory strategy, and managing post-approval regulatory activities. The Pharmaceutical Regulatory Affairs Manager will also be involved in regulatory intelligence gathering, staying current with evolving global regulations, and assessing their impact on the company's product portfolio. Building and maintaining strong relationships with regulatory agencies will be crucial for success. The ideal candidate will possess a Bachelor's or Master's degree in a life science or related field, with substantial experience in pharmaceutical regulatory affairs. Demonstrated success in managing regulatory submissions for new drug applications (NDAs) or marketing authorization applications (MAAs) is essential. Strong knowledge of ICH guidelines and regional regulatory requirements is a must. Excellent written and verbal communication skills, meticulous attention to detail, and strong project management abilities are required. This role offers significant autonomy and the chance to work on a variety of exciting projects, contributing directly to bringing life-changing medicines to patients worldwide. Join our client and be a key player in global drug development.
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2
Remote Pharmaceutical Regulatory Affairs Specialist
6605 Northern, Northern
BHD5200 Monthly
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Posted 2 days ago
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Job Description
Our client, a dynamic pharmaceutical company, is seeking a highly skilled and meticulous Remote Pharmaceutical Regulatory Affairs Specialist to join their global team. This critical role focuses on ensuring compliance with regulatory requirements for pharmaceutical products throughout their lifecycle. You will be responsible for preparing and submitting regulatory filings, interpreting and applying complex regulatory guidelines, and liaising with health authorities. As this is a fully remote position, you will work from your home office, collaborating with regulatory, R&D, and quality assurance departments across different time zones.
Key Responsibilities:
Qualifications:
This is an exceptional opportunity for a seasoned regulatory professional to contribute to groundbreaking pharmaceutical advancements from the comfort of their home.
Key Responsibilities:
- Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs, variations) to health authorities worldwide.
- Interpret and apply national and international regulatory guidelines and regulations to ensure product compliance.
- Maintain regulatory databases and ensure timely updates for all product registrations and lifecycle management activities.
- Liaise with regulatory agencies (e.g., FDA, EMA) on behalf of the company to facilitate regulatory approvals and respond to queries.
- Provide regulatory guidance and support to internal teams, including R&D, clinical development, manufacturing, and quality assurance.
- Conduct regulatory intelligence activities to stay informed about changes in the regulatory landscape and assess their impact on company products.
- Develop and maintain standard operating procedures (SOPs) for regulatory affairs activities.
- Review and approve labeling, promotional materials, and advertising to ensure regulatory compliance.
- Manage post-approval regulatory activities, including annual reports and supplements.
- Participate in regulatory inspections and audits.
- Contribute to the strategic planning of regulatory submissions and product development programs.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree or Pharm.D. is preferred.
- Minimum of 5 years of progressive experience in pharmaceutical regulatory affairs.
- In-depth knowledge of regulatory submission processes and requirements in key markets (e.g., US, Europe, Middle East).
- Experience with various dossier types (e.g., CTD format) and submission platforms.
- Strong understanding of pharmaceutical drug development, manufacturing, and quality assurance principles.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with strong attention to detail.
- Ability to interpret and apply complex regulatory documents.
- Proficiency in regulatory information management systems (RIMs) is a plus.
- Ability to work independently, manage multiple priorities, and meet strict deadlines in a remote environment.
- Strong collaboration and team-working skills.
This is an exceptional opportunity for a seasoned regulatory professional to contribute to groundbreaking pharmaceutical advancements from the comfort of their home.
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3
Senior Pharmaceutical Regulatory Affairs Specialist
101 Saar, Northern
BHD110000 Annually
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Posted 2 days ago
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Job Description
Our client is seeking a highly skilled and experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their esteemed team. This critical role will be responsible for ensuring compliance with all applicable pharmaceutical regulations and guidelines across various international markets. You will play a key role in the preparation, submission, and maintenance of regulatory documentation for new drug applications (NDAs), variations, and renewals. A thorough understanding of global regulatory strategies, health authority requirements (e.g., FDA, EMA), and the pharmaceutical development process is essential. The ideal candidate will possess strong analytical skills, meticulous attention to detail, and the ability to navigate complex regulatory landscapes effectively. This is an office-based position, requiring your presence at our Saar, Northern, BH facilities.
Key Responsibilities:
Qualifications:
This is an excellent opportunity for a dedicated professional to contribute to the success of life-saving medicines within a reputable organization.
Key Responsibilities:
- Develop and implement regulatory strategies for product development and lifecycle management.
- Prepare, review, and submit regulatory dossiers and documentation to health authorities worldwide.
- Liaise directly with regulatory agencies to address queries, facilitate approvals, and maintain positive relationships.
- Interpret and advise on the impact of evolving regulations on company products and processes.
- Ensure that all labeling, advertising, and promotional materials comply with relevant regulations.
- Conduct regulatory due diligence for potential acquisitions or partnerships.
- Manage post-approval regulatory activities, including variations, annual reports, and safety updates.
- Collaborate with R&D, Quality Assurance, Manufacturing, and Commercial teams to provide regulatory guidance and support.
- Maintain comprehensive and up-to-date regulatory intelligence.
- Oversee the regulatory compliance of clinical trial applications and amendments.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline.
- A minimum of 6 years of experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global pharmaceutical regulatory requirements (e.g., ICH guidelines, FDA, EMA, SFDA).
- Proven experience in preparing and submitting NDAs, MAAs, and variations.
- Excellent written and verbal communication skills, with strong attention to detail.
- Ability to analyze complex scientific and regulatory information.
- Strong negotiation and problem-solving skills.
- Experience working with cross-functional teams.
- Proficiency in regulatory information management systems.
- Must be able to work effectively in a team environment and independently.
This is an excellent opportunity for a dedicated professional to contribute to the success of life-saving medicines within a reputable organization.
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4
Remote Pharmaceutical Regulatory Affairs Specialist
501 Bilad Al Qadeem, Capital
BHD80000 Annually
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Posted 3 days ago
Job Viewed
Job Description
Our client is seeking a meticulous and knowledgeable Remote Pharmaceutical Regulatory Affairs Specialist to ensure compliance with global pharmaceutical regulations. This is a fully remote position, providing flexibility while contributing to critical regulatory processes. You will be responsible for preparing and submitting regulatory documentation for drug product approvals, variations, and renewals to health authorities worldwide. This includes compiling dossiers, ensuring adherence to ICH guidelines and regional specific requirements. The ideal candidate will have a thorough understanding of the drug development lifecycle and experience with regulatory submissions in major markets (e.g., US, EU, MENA). You will monitor regulatory changes, assess their impact on company products and strategies, and provide expert advice to internal teams. Key responsibilities include liaising with regulatory agencies, managing post-approval changes, and supporting pharmacovigilance activities. Strong written and verbal communication skills are essential for interacting with health authorities and internal stakeholders. The ability to manage multiple projects, prioritize tasks effectively, and meet tight deadlines in a remote environment is crucial. Proficiency in regulatory information management (RIM) systems is desirable. If you are a detail-oriented regulatory professional passionate about bringing life-saving medications to patients and thrive in a flexible, remote work setting, we encourage you to apply. This role offers a significant opportunity to impact global health outcomes.
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5
Remote Pharmaceutical Regulatory Affairs Specialist
11223 Busaiteen, Muharraq
BHD95000 Annually
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Posted 4 days ago
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Job Description
Our client, a dynamic and rapidly growing pharmaceutical company, is actively seeking a highly organized and experienced Remote Pharmaceutical Regulatory Affairs Specialist to join their global team. This is a fully remote position, offering the flexibility to work from anywhere while playing a critical role in ensuring compliance with global health authorities and facilitating the timely approval of pharmaceutical products. The Pharmaceutical Regulatory Affairs Specialist will be responsible for preparing, submitting, and managing regulatory filings for new drug applications (NDAs), supplemental applications, and other regulatory submissions in accordance with FDA, EMA, and other international regulations. You will conduct thorough reviews of regulatory documentation to ensure accuracy, completeness, and compliance. A key aspect of this role involves staying abreast of evolving regulatory landscapes, guidelines, and policies, and advising internal teams on their impact. You will liaise with regulatory agencies, respond to queries, and manage agency interactions throughout the submission and review processes. This specialist will also be involved in the regulatory assessment of product changes, labeling updates, and promotional materials. Collaborating closely with R&D, Quality Assurance, Manufacturing, and Marketing departments to ensure alignment on regulatory strategies and requirements is crucial. Furthermore, you will contribute to the development and implementation of regulatory strategies for product lifecycle management, ensuring continued compliance post-approval. Maintaining up-to-date regulatory knowledge and disseminating this information across the organization will be an ongoing responsibility. Candidates should possess a Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field. A Master's degree or advanced scientific degree is advantageous. A minimum of 5 years of direct experience in pharmaceutical regulatory affairs is required, with a strong understanding of global regulatory requirements. Proven experience in preparing and submitting major regulatory filings (e.g., INDs, NDAs, MAAs) is essential. Excellent knowledge of ICH guidelines and regional regulatory requirements (e.g., US FDA, EMA) is mandatory. Outstanding written and verbal communication skills, with a meticulous attention to detail, are critical. The ability to work independently, manage deadlines effectively, and collaborate productively in a remote team environment is paramount. This role offers a significant opportunity to contribute to bringing life-changing medications to patients worldwide, all within a flexible, remote work structure, based conceptually around Busaiteen, Muharraq, BH .
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6
Senior Pharmaceutical Regulatory Affairs Specialist
13001 Muharraq, Muharraq
BHD95000 Annually
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Posted 7 days ago
Job Viewed
Job Description
Our client is seeking a highly accomplished Senior Pharmaceutical Regulatory Affairs Specialist to join their dedicated team in Muharraq, Muharraq, BH . This crucial role involves navigating the complex landscape of pharmaceutical regulations to ensure timely approval and market access for our client's innovative products. You will be responsible for preparing, reviewing, and submitting regulatory dossiers to health authorities worldwide, ensuring compliance with all applicable guidelines and standards. The ideal candidate possesses a profound understanding of global regulatory requirements (e.g., FDA, EMA, SFDA), excellent scientific writing skills, and a meticulous approach to documentation. Your responsibilities will include developing regulatory strategies, providing regulatory guidance to cross-functional teams (R&D, clinical, manufacturing), and managing post-approval regulatory activities, such as variations and annual reports. You will act as a key liaison between the company and regulatory agencies, addressing queries and facilitating communications. The ability to interpret scientific data, assess regulatory risks, and contribute to strategic decision-making is essential. This position demands a proactive, detail-oriented professional who can manage multiple projects simultaneously and thrive in a fast-paced environment. We are looking for someone passionate about bringing life-saving medicines to patients by ensuring robust regulatory compliance and efficient submission processes. This is an exceptional opportunity to contribute significantly to the growth and success of a leading pharmaceutical organization.
Key Responsibilities:
Key Responsibilities:
- Develop and implement global regulatory affairs strategies for pharmaceutical products.
- Prepare, review, and submit regulatory dossiers (e.g., CTD, eCTD) to health authorities.
- Ensure compliance with global pharmaceutical regulations and guidelines (FDA, EMA, SFDA, etc.).
- Manage post-approval regulatory activities, including variations, renewals, and annual reports.
- Liaise with regulatory agencies, respond to queries, and manage inspections.
- Provide regulatory guidance and support to R&D, clinical operations, and manufacturing teams.
- Assess the regulatory impact of product changes and new developments.
- Monitor changes in regulatory landscape and advise the company accordingly.
- Conduct regulatory intelligence gathering and risk assessments.
- Maintain regulatory documentation and databases.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs.
- In-depth knowledge of international pharmaceutical regulatory requirements and submission processes.
- Proven experience in preparing and submitting marketing authorization applications.
- Excellent scientific writing, communication, and interpersonal skills.
- Strong analytical and problem-solving abilities.
- Ability to manage multiple projects and meet strict deadlines.
- Experience with regulatory information management systems is a plus.
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7
Remote Pharmaceutical Regulatory Affairs Specialist
25151 Al Muharraq
BHD85000 Annually
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Posted 9 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a highly competent and experienced Remote Pharmaceutical Regulatory Affairs Specialist. This position is fully remote, allowing you to manage critical regulatory functions from the comfort of your home office. You will be responsible for ensuring that our client's pharmaceutical products comply with all relevant national and international regulations and guidelines. This includes preparing and submitting regulatory documentation, liaising with health authorities, and staying abreast of evolving regulatory landscapes. The ideal candidate will possess a strong understanding of drug development processes, regulatory requirements for pharmaceuticals, and excellent attention to detail. You will play a vital role in bringing life-saving medications to market efficiently and compliantly.
Key responsibilities include:
Key responsibilities include:
- Preparing, compiling, and submitting regulatory submissions (e.g., INDs, NDAs, MAAs) to health authorities worldwide.
- Interpreting and advising on regulatory requirements and guidelines for drug development, manufacturing, and marketing.
- Communicating and negotiating with regulatory agencies to facilitate product approvals and address inquiries.
- Developing regulatory strategies for product development and lifecycle management.
- Reviewing and approving labeling, advertising, and promotional materials to ensure regulatory compliance.
- Maintaining regulatory documentation and databases, ensuring accuracy and completeness.
- Monitoring changes in the regulatory environment and assessing their impact on company products and strategies.
- Providing regulatory training and support to internal teams.
- Collaborating with R&D, manufacturing, and quality assurance departments to ensure compliance throughout the product lifecycle.
- Participating in regulatory inspections and audits.
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8
Senior Pharmaceutical Regulatory Affairs Specialist
22450 Al Muharraq
BHD125000 Annually
WhatJobs
Posted 12 days ago
Job Viewed
Job Description
Our client, a globally recognized pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their fully remote team. This critical role involves ensuring compliance with global regulatory requirements for drug development, manufacturing, and marketing. You will be responsible for preparing, reviewing, and submitting regulatory documentation, including New Drug Applications (NDAs), Investigational New Drug (IND) applications, and variations, to health authorities worldwide (e.g., FDA, EMA, PMDA). Your expertise will be vital in interpreting complex regulatory guidelines, providing strategic advice on regulatory pathways, and managing interactions with regulatory agencies. You will collaborate closely with R&D, clinical operations, manufacturing, and quality assurance departments to ensure that all regulatory strategies are aligned with company objectives and product development timelines. Key responsibilities include conducting regulatory intelligence gathering, assessing the regulatory impact of proposed changes, and managing post-approval lifecycle activities. The ideal candidate will possess a strong understanding of pharmaceutical sciences, clinical development, and regulatory affairs within major markets. Excellent written and verbal communication skills, exceptional attention to detail, and strong analytical and problem-solving abilities are essential. This position requires the ability to work independently, manage multiple complex projects concurrently, and build effective relationships with internal teams and external regulatory bodies in a remote work environment.
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