5 Senior Remote Pharmaceutical Regulatory Affairs Specialist jobs in whatjobs

Senior Remote Pharmaceutical Regulatory Affairs Specialist

90100 Mangu KES135000 Annually WhatJobs

Posted 20 days ago

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Job Description

full-time
Our client, a dynamic and growing pharmaceutical company, is seeking a highly experienced Senior Remote Pharmaceutical Regulatory Affairs Specialist to join their dedicated team. This fully remote role is crucial for navigating the complex regulatory landscape and ensuring compliance with global pharmaceutical standards. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and advising on regulatory strategies to support product development and market approval. The ideal candidate possesses a strong understanding of pharmaceutical regulations, meticulous attention to detail, and proven success in a remote work setting.

Responsibilities:
  • Prepare, review, and submit regulatory dossiers for drug applications (e.g., IND, NDA, MAA) to relevant health authorities.
  • Ensure compliance with current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and other relevant regulatory guidelines.
  • Liaise directly with regulatory agencies (e.g., FDA, EMA, local health authorities) to facilitate the review process and respond to queries.
  • Develop and implement global regulatory strategies to support product development and lifecycle management.
  • Monitor and interpret changes in regulatory requirements and provide timely updates and recommendations to internal teams.
  • Assess the regulatory impact of product changes, manufacturing processes, and promotional materials.
  • Collaborate closely with R&D, Quality Assurance, Clinical Operations, and Commercial teams to ensure regulatory requirements are met.
  • Maintain regulatory databases and ensure the accuracy and completeness of regulatory documentation.
  • Provide regulatory training and guidance to internal stakeholders.
  • Conduct regulatory intelligence activities to stay ahead of evolving requirements.
Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
  • Minimum of 7 years of experience in pharmaceutical regulatory affairs.
  • Demonstrated experience working effectively in a remote capacity, managing regulatory submissions and communications from a distance.
  • In-depth knowledge of global pharmaceutical regulatory requirements and submission processes (e.g., ICH guidelines).
  • Proven experience in preparing and submitting various types of regulatory filings.
  • Excellent written and verbal communication skills, with a strong ability to articulate complex regulatory information clearly.
  • Strong analytical and problem-solving skills, with meticulous attention to detail.
  • Proficiency in regulatory information management systems (RIMS) and document management systems.
  • Ability to work independently, manage multiple priorities, and meet strict deadlines.
  • Experience with a variety of therapeutic areas is a plus.
This is an outstanding opportunity to make a significant impact on global health from a remote location, contributing to bringing essential medicines to patients worldwide. If you are a highly skilled and motivated regulatory affairs professional with a passion for compliance and innovation, we encourage you to apply. The role is associated with our client's operations near Machakos, Machakos, KE , but is performed entirely remotely.
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Senior Remote Pharmaceutical Regulatory Affairs Specialist

60200 Meru , Eastern KES110000 Annually WhatJobs

Posted 13 days ago

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Job Description

full-time
Our client, a dynamic pharmaceutical organization, is seeking a highly experienced Senior Remote Pharmaceutical Regulatory Affairs Specialist to ensure compliance with national and international drug regulations. This is a critical, fully remote position responsible for managing the regulatory submission process, maintaining product registrations, and ensuring that all products meet stringent legal and quality standards. You will play a pivotal role in preparing, reviewing, and submitting regulatory dossiers for new drug applications, variations, and renewals to various health authorities. Key responsibilities include interpreting regulatory guidelines, advising project teams on regulatory requirements, assessing the regulatory impact of product changes, and overseeing post-marketing surveillance activities. The ideal candidate possesses a comprehensive understanding of pharmaceutical regulatory affairs, a keen eye for detail, and exceptional analytical and communication skills. Strong project management abilities and the capacity to navigate complex regulatory landscapes are essential. Proficiency in regulatory submission software and a solid grasp of pharmaceutical manufacturing processes are required. This role demands a proactive approach to regulatory compliance, effective collaboration with internal departments (R&D, Clinical, Manufacturing), and external stakeholders, including regulatory agencies. A commitment to ensuring patient safety and product efficacy through rigorous regulatory adherence is paramount. This is an exceptional opportunity for a seasoned regulatory affairs professional to contribute to life-saving medications and drive compliance initiatives remotely.

Responsibilities:
  • Prepare, review, and submit regulatory dossiers for pharmaceutical products to health authorities (e.g., NAFDAC, PPB, FDA, EMA).
  • Manage and maintain product registrations, licenses, and variations.
  • Interpret and communicate evolving national and international regulatory requirements to relevant teams.
  • Advise project teams on regulatory strategies and compliance requirements throughout the product lifecycle.
  • Assess the regulatory impact of product changes, manufacturing processes, and labeling updates.
  • Oversee post-marketing surveillance activities, including adverse event reporting and pharmacovigilance.
  • Conduct regulatory intelligence gathering and analysis to anticipate future trends and requirements.
  • Liaise with regulatory agencies to address queries and facilitate the approval process.
  • Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant guidelines.
  • Review marketing materials and promotional claims for regulatory compliance.
  • Develop and implement regulatory strategies to support product development and commercialization.
  • Maintain regulatory databases and documentation with utmost accuracy.
Qualifications:
  • Master's degree or Ph.D. in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related scientific field.
  • Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
  • In-depth knowledge of regulatory requirements for drug products in key markets (e.g., Kenya, EU, US).
  • Proven experience in preparing and submitting regulatory dossiers (e.g., CTD format).
  • Strong understanding of pharmaceutical development, manufacturing, and quality assurance.
  • Excellent analytical, problem-solving, and critical thinking skills.
  • Exceptional written and verbal communication and negotiation skills.
  • Proficiency in regulatory information management systems and relevant software.
  • Ability to work independently and manage multiple projects effectively in a remote environment.
  • Strong organizational skills and meticulous attention to detail.
  • Demonstrated ability to build relationships with regulatory authorities.
This is a fully remote position supporting regulatory compliance for operations in Meru, Meru, KE .
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Senior Remote Pharmaceutical Regulatory Affairs Specialist

30200 Moiben KES200000 Monthly WhatJobs

Posted 5 days ago

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Job Description

full-time
Our client, a leading pharmaceutical innovator, is seeking a highly experienced Senior Remote Pharmaceutical Regulatory Affairs Specialist to navigate the complex landscape of drug approval and compliance. This is a fully remote position, allowing you to contribute your expertise in regulatory strategy and submissions from your home office. You will play a crucial role in ensuring that our client's products meet all necessary regulatory requirements in various global markets, from early-stage development through post-market surveillance. The ideal candidate possesses a deep understanding of global regulatory frameworks, excellent analytical skills, and a meticulous approach to documentation. Your contributions will be vital in bringing life-saving therapies to patients.

Key Responsibilities:
  • Develop and implement global regulatory strategies for pharmaceutical product development and registration.
  • Prepare, review, and submit regulatory dossiers to health authorities (e.g., FDA, EMA, national agencies).
  • Interpret and advise on complex regulatory requirements, guidelines, and policies.
  • Manage regulatory project timelines and ensure timely submission of all required documentation.
  • Liaise with health authorities and respond to their queries and requests during the review process.
  • Monitor changes in the regulatory landscape and assess their impact on the company's products and strategies.
  • Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant regulations.
  • Collaborate closely with R&D, clinical development, manufacturing, and commercial teams.
  • Provide regulatory input for labeling, advertising, and promotional materials.
  • Conduct regulatory intelligence activities and stay updated on industry best practices.
Qualifications:
  • Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field. A Master's degree or PhD is a significant advantage.
  • Minimum of 7-10 years of experience in pharmaceutical regulatory affairs.
  • Proven track record of successful regulatory submissions and approvals in major markets.
  • In-depth knowledge of global regulatory requirements for pharmaceuticals.
  • Excellent understanding of drug development processes, clinical trials, and manufacturing.
  • Strong analytical, problem-solving, and critical thinking skills.
  • Exceptional written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
  • Proficiency in regulatory information management (RIM) systems and document management systems.
  • Ability to manage multiple projects, prioritize tasks, and work effectively under pressure in a remote setting.
  • Detail-oriented, highly organized, and committed to accuracy.
  • A dedicated home office with a stable, high-speed internet connection is mandatory for this fully remote role, supporting our client's global operations that may involve regulatory activities impacting the Eldoret, Uasin Gishu, KE region and beyond.
This is a challenging and rewarding opportunity for a senior regulatory affairs professional seeking to advance their career in a flexible, remote work environment. Join a team dedicated to advancing global health through rigorous compliance and strategic regulatory leadership.
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Senior Remote Pharmaceutical Regulatory Affairs Specialist

00700 Shella KES1000000 Annually WhatJobs

Posted 19 days ago

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Job Description

full-time
Our client is seeking a highly knowledgeable and experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their global team in a fully remote capacity. This critical role involves navigating the complex landscape of pharmaceutical regulations to ensure compliance and facilitate the approval of new drug products and medical devices. The ideal candidate will possess a deep understanding of regulatory requirements in key markets, including submission strategies, dossier preparation, and post-market surveillance. You will be responsible for advising R&D, clinical, and commercial teams on regulatory strategies, preparing and submitting regulatory dossiers, and maintaining strong relationships with health authorities. This position demands meticulous attention to detail, excellent scientific acumen, and superior communication skills to effectively manage regulatory processes remotely. The ability to interpret and apply evolving regulatory guidelines is paramount.

Responsibilities:
  • Develop and implement global regulatory strategies for product development, registration, and lifecycle management.
  • Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs, variations) to health authorities worldwide.
  • Interpret and advise on regulatory requirements, guidelines, and changes impacting pharmaceutical products.
  • Liaise effectively with regulatory agencies, acting as the primary point of contact for submissions and inquiries.
  • Collaborate closely with cross-functional teams, including R&D, clinical affairs, quality assurance, manufacturing, and marketing, to ensure alignment with regulatory strategies.
  • Provide regulatory input and guidance throughout the product development lifecycle, from early-stage research to post-market activities.
  • Oversee and manage post-approval regulatory activities, including annual reports, supplements, and labeling updates.
  • Conduct regulatory intelligence activities to stay informed about global regulatory trends and competitor strategies.
  • Ensure compliance with all applicable national and international pharmaceutical regulations and guidelines.
  • Contribute to the development and implementation of departmental SOPs and best practices.
Qualifications:
  • Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science discipline.
  • Minimum of 8 years of experience in pharmaceutical regulatory affairs.
  • In-depth knowledge of regulatory submission processes and requirements in major markets (e.g., FDA, EMA, PMDA).
  • Proven experience in preparing and submitting complex regulatory dossiers.
  • Strong understanding of drug development processes, clinical trials, and manufacturing controls.
  • Excellent analytical, problem-solving, and critical thinking skills.
  • Exceptional written and verbal communication skills, with the ability to articulate complex regulatory information clearly and concisely.
  • Demonstrated ability to manage multiple projects simultaneously and meet strict deadlines in a remote environment.
  • Proficiency in regulatory information management systems and documentation tools.
  • Ability to work independently and as part of a global, virtual team.
This is a challenging and rewarding opportunity for a senior regulatory affairs professional to make a significant impact on bringing life-saving medicines to market, working remotely.
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Senior Remote Pharmaceutical Regulatory Affairs Specialist

80100 Nairobi, Nairobi KES150000 Annually WhatJobs

Posted 3 days ago

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Job Description

full-time
Our client is seeking a highly experienced Senior Remote Pharmaceutical Regulatory Affairs Specialist to lead and manage regulatory submissions and compliance efforts. This fully remote position allows you to contribute significantly to bringing life-saving medications to market from the convenience of your home office. You will be responsible for interpreting and applying global regulatory guidelines, preparing comprehensive regulatory dossiers, and ensuring timely submissions to health authorities worldwide. Key duties include developing regulatory strategies, liaising with regulatory agencies, conducting regulatory intelligence activities, and advising internal teams on regulatory requirements and potential challenges. The ideal candidate will possess a strong background in pharmaceutical sciences or a related field, with extensive experience in regulatory affairs for both pre-market approval and post-market activities. A deep understanding of regulatory submission processes (e.g., CTD, IND, NDA) and familiarity with international regulatory landscapes (e.g., FDA, EMA) are essential. Excellent written and verbal communication skills are critical for effectively preparing submission documents and interacting with regulatory bodies. You must demonstrate strong analytical and problem-solving abilities, meticulous attention to detail, and the capacity to manage complex projects under tight deadlines. This role requires a proactive and strategic thinker with the ability to anticipate regulatory changes and provide sound advice. Proficiency in regulatory information management systems is a plus. Join our client’s esteemed regulatory team and play a vital role in ensuring the successful and compliant market access of innovative pharmaceutical products. Your expertise will be invaluable in navigating the complex regulatory environment.
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