102 Regulatory Affairs Specialist jobs in Manama
Regulatory Affairs Specialist
23456 Al Ghurayfah
BHD105000 Annually
WhatJobs
Posted 16 days ago
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Job Description
Our client is actively searching for a dedicated and detail-oriented Regulatory Affairs Specialist to join their fully remote pharmaceutical team. In this critical role, you will be responsible for ensuring that all products meet the stringent regulatory requirements of various international markets. Your expertise will be vital in navigating the complex landscape of pharmaceutical regulations, from initial product development through to marketing authorization and lifecycle management. Key responsibilities include preparing and submitting regulatory dossiers (e.g., IND, NDA, MAA), responding to queries from health authorities, and staying abreast of evolving regulatory guidelines and legislation worldwide. You will liaise with internal departments, including R&D, Quality Assurance, and Commercial, as well as external partners and regulatory agencies, all within a remote work environment. A strong understanding of global regulatory submission processes and experience with electronic submission platforms are essential. The ability to analyze complex scientific data and translate it into clear, concise regulatory documents is a must. You will play a key role in developing regulatory strategies to support product approval and commercialization. Excellent written and verbal communication skills are paramount, as is a meticulous approach to documentation and compliance. This position requires a proactive individual with strong analytical and problem-solving abilities who thrives in an independent, remote setting. A Bachelor's or Master's degree in a relevant scientific or technical field (e.g., pharmacy, chemistry, biology) and a minimum of 5 years of experience in pharmaceutical regulatory affairs are required. Experience with specific therapeutic areas or product types may be an advantage. This is an exceptional opportunity to contribute to global health initiatives by facilitating the timely access of innovative medicines to patients, all while enjoying the flexibility of a remote career.
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0
Senior Regulatory Affairs Specialist
622 Gudaibiya, Capital
BHD90000 Annually
WhatJobs
Posted 8 days ago
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Job Description
Our client, a leading innovator in the (mention relevant industry, e.g., technology, healthcare) sector, is seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join their expanding team. This is a fully remote position, offering the opportunity to contribute to critical projects from anywhere. The ideal candidate will possess a comprehensive understanding of regulatory frameworks, compliance strategies, and submission processes relevant to our industry. You will play a crucial role in ensuring our products and services meet all necessary legal and regulatory requirements, facilitating market entry and ongoing compliance.
Key Responsibilities:
Qualifications:
This fully remote role offers the chance to significantly impact regulatory strategy and compliance from your home office.
Key Responsibilities:
- Develop and implement regulatory strategies for new and existing products/services in alignment with global compliance standards.
- Prepare, review, and submit regulatory documentation to relevant authorities (e.g., FDA, EMA, local regulatory bodies).
- Interpret and communicate complex regulatory requirements to internal teams, including R&D, product development, and marketing.
- Monitor changes in regulatory landscapes and proactively assess their impact on the company's operations and product portfolio.
- Act as the primary point of contact with regulatory agencies, managing communications and addressing inquiries.
- Conduct regulatory audits and ensure internal compliance with established procedures and guidelines.
- Identify potential regulatory risks and develop mitigation strategies.
- Collaborate with cross-functional teams to ensure product development and manufacturing processes adhere to regulatory standards.
- Maintain accurate and organized regulatory records and databases.
- Contribute to the development of regulatory policies and standard operating procedures (SOPs).
- Provide training and guidance to internal stakeholders on regulatory matters.
- Support post-market surveillance activities and manage regulatory reporting requirements.
Qualifications:
- Bachelor's or Master's degree in a relevant scientific, technical, or legal field.
- Minimum of 6 years of progressive experience in regulatory affairs, preferably within the (mention relevant industry) sector.
- Proven track record of successful regulatory submissions and approvals.
- In-depth knowledge of global regulatory requirements and guidelines pertinent to our industry.
- Excellent understanding of product lifecycle management and associated regulatory considerations.
- Strong analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with the ability to present complex information clearly and persuasively.
- Proficiency in regulatory information management systems and relevant software.
- Ability to work independently, manage priorities effectively, and meet tight deadlines in a remote environment.
- Detail-oriented with a high degree of accuracy.
- Experience in international regulatory affairs is a significant advantage.
This fully remote role offers the chance to significantly impact regulatory strategy and compliance from your home office.
This advertiser has chosen not to accept applicants from your region.
1
Senior Regulatory Affairs Specialist
101 Bilad Al Qadeem, Capital
BHD90000 Annually
WhatJobs
Posted 18 days ago
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Job Description
Our client, a distinguished law firm renowned for its expertise in corporate and commercial law, is seeking a highly knowledgeable and meticulous Senior Regulatory Affairs Specialist. This hybrid role will be based at our **Tubli, Capital, BH** offices and will focus on navigating the complex landscape of regulatory compliance for a diverse clientele. You will be responsible for monitoring regulatory changes, interpreting legislation, and developing strategies to ensure client adherence to all applicable laws and standards across various industries, including finance, healthcare, and technology. The ideal candidate will possess a deep understanding of Bahraini regulatory frameworks, excellent analytical skills, and the ability to translate complex regulations into actionable advice. You will work closely with legal teams, consultants, and clients to provide expert guidance, prepare regulatory submissions, and manage compliance initiatives. This position requires a proactive approach, meticulous attention to detail, and the ability to manage multiple client needs effectively.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Monitor, analyze, and interpret regulatory changes and legislation relevant to client industries.
- Develop and implement compliance strategies to ensure adherence to laws and regulations.
- Prepare and submit regulatory documentation and applications to relevant authorities.
- Conduct regulatory impact assessments and advise clients on potential risks and opportunities.
- Liaise with government agencies, regulatory bodies, and industry associations on behalf of clients.
- Assist in the development and implementation of internal compliance policies and procedures.
- Provide expert advice and training to clients on regulatory matters.
- Manage ongoing regulatory filings and reporting requirements.
- Conduct due diligence on regulatory aspects of potential transactions or business ventures.
- Stay abreast of emerging regulatory trends and best practices.
Qualifications:
- Bachelor's degree in Law, Public Administration, Economics, or a related field. Master's degree preferred.
- Minimum of 6 years of experience in regulatory affairs, compliance, or legal advisory roles, preferably within a law firm or corporate legal department.
- In-depth knowledge of regulatory frameworks in Bahrain across multiple sectors.
- Proven experience in regulatory analysis, strategy development, and submission management.
- Excellent analytical, research, and problem-solving skills.
- Strong understanding of legislative processes and government relations.
- Exceptional written and verbal communication skills, with the ability to articulate complex legal and regulatory information clearly.
- Meticulous attention to detail and organizational skills.
- Ability to manage multiple projects simultaneously and meet strict deadlines.
- Proficiency in relevant legal databases and compliance software.
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2
Regulatory Affairs Specialist - Pharmaceutical
8765 Seef, Capital
BHD70000 Annually
WhatJobs
Posted 20 days ago
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Job Description
Our client, a distinguished pharmaceutical company, is looking for a meticulous and knowledgeable Regulatory Affairs Specialist to join their team in **Seef, Capital, BH**. This role is essential for ensuring that the company's products comply with all relevant national and international regulations throughout their lifecycle.
The successful candidate will be responsible for preparing, submitting, and maintaining regulatory filings for new drug applications, variations, and renewals. You will need to stay up-to-date with evolving regulatory landscapes, provide guidance on regulatory requirements to internal teams, and liaise with health authorities. A strong understanding of pharmaceutical development, manufacturing, and quality systems is crucial.
Key Responsibilities:
The successful candidate will be responsible for preparing, submitting, and maintaining regulatory filings for new drug applications, variations, and renewals. You will need to stay up-to-date with evolving regulatory landscapes, provide guidance on regulatory requirements to internal teams, and liaise with health authorities. A strong understanding of pharmaceutical development, manufacturing, and quality systems is crucial.
Key Responsibilities:
- Prepare and submit regulatory documentation to health authorities for product registration and lifecycle management.
- Ensure compliance with all applicable regulations, guidelines, and standards.
- Review and approve product labeling, promotional materials, and advertising.
- Liaise with regulatory agencies, responding to queries and facilitating approvals.
- Monitor changes in the regulatory environment and assess their impact on the company's products.
- Provide regulatory input and guidance to R&D, manufacturing, and marketing teams.
- Manage post-approval changes and ensure timely submission of variations.
- Develop and implement regulatory strategies for product development and commercialization.
- Maintain regulatory databases and filing systems.
- Participate in regulatory inspections and audits.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life sciences field. Master's degree is a plus.
- Minimum of 4 years of experience in regulatory affairs within the pharmaceutical industry.
- In-depth knowledge of pharmaceutical regulations and guidelines (e.g., FDA, EMA, SFDA).
- Proven experience in preparing and submitting regulatory dossiers (e.g., CTD format).
- Strong understanding of drug development, manufacturing processes, and quality assurance.
- Excellent written and verbal communication skills.
- Detail-oriented with strong analytical and problem-solving abilities.
- Ability to manage multiple projects and meet tight deadlines.
- Proficiency in regulatory information management systems.
- Experience interacting with health authorities.
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3
Senior Regulatory Affairs Specialist
101 Bilad Al Qadeem, Capital
BHD85000 Annually
WhatJobs
Posted 23 days ago
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Job Description
Our client, a prominent player in the pharmaceutical industry, is seeking a seasoned Senior Regulatory Affairs Specialist to join their team. This is a fully remote position, allowing you the flexibility to work from your preferred location. You will be responsible for managing the preparation, submission, and maintenance of regulatory filings for pharmaceutical products in various global markets. This includes ensuring compliance with all relevant regulatory guidelines and requirements. Key responsibilities include developing regulatory strategies, authoring submission documents, liaising with regulatory agencies, and providing regulatory input throughout the product lifecycle. You will also stay abreast of evolving regulatory landscapes and advise internal teams on potential impacts. The ideal candidate will possess a Bachelor's or Master's degree in a life science, pharmacy, or a related field, combined with significant experience in regulatory affairs within the pharmaceutical or biotechnology sectors. A deep understanding of global regulatory submission requirements (e.g., FDA, EMA) is essential. Strong written and verbal communication skills are critical for preparing high-quality submission documents and effectively interacting with regulatory authorities and internal stakeholders. Excellent organizational skills, meticulous attention to detail, and the ability to manage multiple complex projects simultaneously are paramount. You must be proficient in regulatory information management systems and have a proven track record of successfully navigating complex regulatory pathways. This role offers the chance to significantly contribute to bringing life-saving therapies to patients worldwide, working within a collaborative and supportive remote environment. Our client is committed to fostering innovation and professional development for its employees.
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4
Remote Pharmaceutical Regulatory Affairs Specialist
501 Bilad Al Qadeem, Capital
BHD80000 Annually
WhatJobs
Posted 8 days ago
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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
Lead Regulatory Affairs Specialist - Remote
305 Manama, Capital
BHD110000 Annually
WhatJobs
Posted 13 days ago
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Job Description
Our client is seeking a highly experienced and knowledgeable Lead Regulatory Affairs Specialist to join their fully remote legal and compliance team. This senior position will be responsible for ensuring that our client's products and operations comply with all applicable national and international laws and regulations within their industry. You will lead the development and implementation of regulatory strategies, prepare and submit regulatory filings, and liaise with regulatory authorities. Your responsibilities will include monitoring changes in the regulatory landscape, assessing their impact on the company, and advising internal stakeholders on compliance requirements. You will also oversee the review of product labeling, marketing materials, and technical documentation to ensure regulatory adherence. The ideal candidate will possess a deep understanding of regulatory frameworks, strong analytical skills, and exceptional attention to detail. You must be adept at interpreting complex regulations, developing practical compliance solutions, and communicating effectively with both technical and non-technical audiences. This role demands strong project management skills and the ability to work autonomously in a remote setting, managing multiple projects simultaneously. A Bachelor's degree in a relevant scientific field, Law, or Business is required; a Master's degree or advanced degree is preferred. A minimum of 8 years of progressive experience in regulatory affairs, with a proven track record of successful product registrations and regulatory submissions, is essential. Experience in the specific industry of our client is highly desirable. Excellent written and verbal communication skills are paramount for effective remote collaboration and interaction with global regulatory bodies.
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6
Remote Pharmaceutical Regulatory Affairs Specialist
25151 Al Muharraq
BHD85000 Annually
WhatJobs
Posted 14 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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7
Senior Pharmaceutical Regulatory Affairs Specialist
22450 Al Muharraq
BHD125000 Annually
WhatJobs
Posted 17 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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8
Senior Regulatory Affairs Specialist (Remote)
221 Ghuraifa, Capital
BHD110000 Annually
WhatJobs
Posted 22 days ago
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Job Description
We are seeking a meticulous and experienced Senior Regulatory Affairs Specialist to join our expanding legal and compliance team. This is a fully remote position, allowing you to contribute your expertise from anywhere. You will be responsible for ensuring our products and operations comply with all relevant national and international regulatory requirements. Key duties include preparing, reviewing, and submitting regulatory filings, such as marketing authorization applications, variations, and renewals. You will also monitor changes in regulatory legislation and guidelines, assess their impact, and ensure timely implementation of necessary updates. This role requires close collaboration with R&D, manufacturing, quality assurance, and commercial departments to provide regulatory guidance and support throughout the product lifecycle. The ideal candidate will possess a deep understanding of regulatory strategies and a proven track record in navigating complex regulatory landscapes. Excellent analytical and problem-solving skills are essential, as is the ability to interpret and apply regulatory requirements effectively. You must be highly organized, detail-oriented, and capable of managing multiple projects simultaneously in a fast-paced, remote environment. Proficiency with regulatory information management systems and strong communication skills are vital for success. We are looking for candidates with a Bachelor's or Master's degree in a relevant scientific or legal field, and a minimum of 5 years of progressive experience in pharmaceutical or medical device regulatory affairs. A proactive approach to regulatory challenges and a commitment to maintaining the highest standards of compliance are expected. This is an exceptional opportunity for a regulatory expert to make a significant contribution to our global compliance efforts from a remote setting.
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