6 Senior Regulatory Affairs Specialist jobs in whatjobs
Senior Regulatory Affairs Specialist
Posted 20 days ago
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Job Description
The Senior Regulatory Affairs Specialist will be responsible for developing and executing regulatory strategies for product registration and lifecycle management. You will ensure compliance with all relevant regulatory requirements in target markets, prepare and submit regulatory documentation, and serve as a key liaison with health authorities. This position demands a deep understanding of pharmaceutical regulations and excellent communication skills.
Key Responsibilities:
- Develop and implement regulatory strategies for new product registrations and post-approval changes.
- Prepare, review, and submit high-quality regulatory dossiers to health authorities in accordance with applicable guidelines (e.g., ICH, WHO).
- Serve as the primary point of contact for regulatory agencies, responding to queries and facilitating communication.
- Monitor changes in the regulatory landscape and assess their impact on the company's products and strategies.
- Ensure compliance with all relevant pharmaceutical regulations, guidelines, and company policies.
- Collaborate closely with cross-functional teams, including R&D, quality assurance, manufacturing, and marketing, to ensure alignment on regulatory matters.
- Manage the regulatory review and approval process for labeling, promotional materials, and advertising.
- Provide regulatory guidance and training to internal stakeholders.
- Maintain regulatory documentation and databases.
- Participate in regulatory intelligence activities and competitor analysis.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 6 years of experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting regulatory dossiers for various types of medicinal products.
- In-depth knowledge of global pharmaceutical regulations and guidelines.
- Excellent understanding of drug development processes and lifecycle management.
- Strong analytical and problem-solving skills.
- Exceptional written and verbal communication skills, with meticulous attention to detail.
- Ability to work independently, manage multiple priorities, and meet tight deadlines in a remote setting.
- Proficiency in regulatory information management systems is a plus.
- Must be legally authorized to work in Kenya.
Senior Regulatory Affairs Specialist
Posted 12 days ago
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Job Description
Senior Regulatory Affairs Specialist
Posted 13 days ago
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Job Description
As a Senior Regulatory Affairs Specialist, you will play a critical role in the strategic planning and execution of regulatory submissions for new drug applications (NDAs), investigational new drug applications (INDs), and variations. Your expertise in regulatory strategy, dossier preparation, and interaction with health authorities will be paramount. You will work closely with R&D, clinical, and manufacturing teams to ensure that all documentation meets the stringent requirements of regulatory agencies. The ideal candidate possesses a strong understanding of pharmaceutical regulations, excellent analytical and writing skills, and the ability to manage multiple complex projects simultaneously in a remote setting.
Key Responsibilities:
- Develop and implement regulatory strategies for product development and lifecycle management.
- Prepare, review, and submit regulatory dossiers (e.g., IND, NDA, variations) to health authorities worldwide.
- Liaise with regulatory agencies to facilitate timely review and approval of submissions.
- Provide regulatory guidance and support to cross-functional teams, including R&D, clinical operations, quality assurance, and manufacturing.
- Interpret and apply relevant national and international regulations, guidelines, and standards.
- Monitor regulatory changes and assess their impact on company products and strategies.
- Manage post-approval regulatory commitments and lifecycle management activities.
- Conduct regulatory intelligence gathering and competitor analysis.
- Contribute to the development and maintenance of regulatory procedures and policies.
- Review promotional materials for regulatory compliance.
- Ensure all regulatory documentation is accurate, complete, and compliant.
- Lead regulatory interactions during inspections and audits.
- A Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline. Advanced degree preferred.
- Minimum of 6 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Proven track record of successful regulatory submissions and approvals.
- In-depth knowledge of global pharmaceutical regulatory requirements and guidelines (e.g., ICH, FDA, EMA).
- Excellent scientific understanding of drug development processes.
- Strong analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with a keen eye for detail.
- Proficiency in regulatory information management systems and document management systems.
- Ability to manage multiple projects, prioritize tasks, and meet tight deadlines in a fast-paced, remote environment.
- Strong interpersonal skills and the ability to collaborate effectively with cross-functional teams.
- Eligibility to work remotely from Nyeri, Nyeri, KE or other locations in Kenya.
Senior Regulatory Affairs Specialist
Posted 20 days ago
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Job Description
Key responsibilities include developing regulatory strategies for product approvals, evaluating the regulatory implications of product changes, and leading interactions with health authorities. You will also contribute to the development of regulatory policies and procedures, conduct regulatory intelligence gathering, and support product lifecycle management. Collaboration with R&D, quality assurance, and commercial teams will be integral to success. The ideal candidate will possess exceptional analytical skills, meticulous attention to detail, and the ability to navigate complex regulatory frameworks with confidence. Strong project management and organizational skills are vital to manage multiple submissions and deadlines effectively.
This is a fully remote position, offering the flexibility to work from any location within Kenya. We are looking for candidates with a Bachelor's or Master's degree in a relevant scientific discipline (e.g., Pharmacy, Chemistry, Biology), along with a minimum of 6 years of direct experience in pharmaceutical regulatory affairs. Experience with specific therapeutic areas or global regulatory submissions (e.g., FDA, EMA) is highly advantageous. Excellent written and verbal communication skills are required for preparing clear and concise regulatory documentation and engaging with regulatory agencies. Join a leading organization that values scientific rigor and offers significant opportunities for professional growth and impact in the pharmaceutical industry.
Senior Regulatory Affairs Specialist
Posted 16 days ago
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Job Description
Responsibilities:
- Develop and implement regulatory strategies for product registration and lifecycle management.
- Prepare, review, and submit regulatory documentation (e.g., CTD modules, variations, renewals) to health authorities.
- Interpret and apply relevant national and international pharmaceutical regulations.
- Liaise effectively with regulatory agencies (e.g., Pharmacy and Poisons Board) to facilitate product approvals and address queries.
- Provide regulatory guidance and support to cross-functional teams, including R&D, Quality Assurance, and Marketing.
- Monitor regulatory changes and assess their impact on the company's products and operations.
- Conduct regulatory compliance assessments and ensure adherence to Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) where applicable.
- Manage post-approval regulatory activities, including variations, supplements, and annual reports.
- Review and approve labeling and promotional materials for regulatory compliance.
- Maintain regulatory databases and ensure accurate record-keeping.
- Contribute to the development of internal regulatory policies and procedures.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field; advanced degree (Master's or PhD) is a plus.
- Minimum of 7 years of experience in pharmaceutical regulatory affairs.
- In-depth knowledge of Kenyan pharmaceutical regulations and guidelines.
- Experience with dossier preparation (e.g., eCTD format) and submission processes.
- Proven ability to interact with regulatory authorities.
- Strong understanding of drug development, manufacturing, and quality assurance principles.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional attention to detail and organizational abilities.
- Strong written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
- Ability to work independently, manage priorities, and meet tight deadlines in a remote environment.
- Proficiency in regulatory information management systems is desirable.
Senior Regulatory Affairs Specialist
Posted 1 day ago
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Job Description
The ideal candidate will possess a deep understanding of the pharmaceutical regulatory landscape, excellent analytical skills, and a meticulous attention to detail. You will work closely with R&D, manufacturing, quality assurance, and marketing departments to ensure that product development and lifecycle management align with regulatory requirements. This includes staying abreast of evolving regulatory guidelines and advising the company on strategic regulatory approaches. Your expertise will be vital in facilitating the approval and commercialization of pharmaceutical products, ensuring patient safety and product efficacy.
Key Responsibilities:
- Prepare, review, and submit regulatory submissions (e.g., NDAs, ANDAs, variations) to health authorities.
- Manage the lifecycle of regulatory approvals, including post-approval supplements and renewals.
- Interpret and advise on regulatory guidelines and their impact on product development and commercialization.
- Liaise with health authorities and respond to queries during the review process.
- Develop and implement regulatory strategies for new product development and existing products.
- Conduct regulatory due diligence for potential business development opportunities.
- Ensure compliance with GMP, GCP, and GLP regulations.
- Train and mentor junior regulatory affairs staff.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life sciences field.
- Minimum of 5-7 years of progressive experience in pharmaceutical regulatory affairs.
- In-depth knowledge of regulatory submission processes and requirements in key markets.
- Proven experience in preparing and managing regulatory dossiers.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong communication, negotiation, and interpersonal skills, essential for remote interactions with health authorities and internal teams.
- Proficiency in regulatory information management systems is a plus.
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