7 Remote Senior Pharmaceutical Regulatory Affairs Specialist jobs in whatjobs

Remote Senior Pharmaceutical Regulatory Affairs Specialist

50300 Tuwan KES200000 Annually WhatJobs

Posted 20 days ago

Job Viewed

Tap Again To Close

Job Description

full-time
Our client is seeking a highly experienced and knowledgeable Senior Pharmaceutical Regulatory Affairs Specialist for a fully remote position. You will be responsible for ensuring that our pharmaceutical products comply with all relevant national and international regulatory requirements throughout their lifecycle. This critical role involves developing and executing regulatory strategies, preparing submission dossiers, and liaising with health authorities to secure product approvals and maintain compliance. The ideal candidate will possess a deep understanding of pharmaceutical regulations, guidelines, and submission processes across key markets. Your expertise will be vital in interpreting complex regulatory requirements, advising product development teams, and ensuring timely and successful submissions. Responsibilities include preparing and reviewing regulatory documentation, managing post-approval variations, and staying abreast of evolving regulatory landscapes. You will collaborate closely with R&D, clinical affairs, quality assurance, and commercial teams, virtually, to achieve regulatory objectives. Exceptional analytical, communication, and project management skills are essential for success in this role, enabling effective navigation of the regulatory environment and seamless collaboration within a remote setting. This is an excellent opportunity to contribute to bringing life-saving medicines to patients worldwide.
Responsibilities:
  • Develop and implement global regulatory strategies for pharmaceutical product development and lifecycle management.
  • Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs) to health authorities.
  • Act as the primary point of contact with regulatory agencies, responding to queries and facilitating communication.
  • Ensure compliance with all applicable pharmaceutical regulations, guidelines, and standards.
  • Manage post-approval regulatory activities, including variations, renewals, and annual reports.
  • Assess the regulatory implications of product changes, manufacturing processes, and clinical trial data.
  • Advise project teams on regulatory requirements and strategies throughout the product development process.
  • Review and approve labeling, promotional materials, and advertising for regulatory compliance.
  • Stay current with global regulatory intelligence, trends, and policy changes.
  • Contribute to the development of internal SOPs and quality systems related to regulatory affairs.
  • Manage relationships with external consultants and regulatory service providers.
  • Ensure accurate and timely maintenance of regulatory documentation and databases.
Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
  • Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
  • Proven track record of successful regulatory submissions and approvals in major markets (e.g., US, EU, Japan).
  • In-depth knowledge of ICH guidelines and specific regional regulatory requirements.
  • Experience with various dosage forms and therapeutic areas is advantageous.
  • Excellent written and verbal communication skills, with strong attention to detail.
  • Proficiency in regulatory information management systems.
  • Strong analytical and problem-solving abilities.
  • Demonstrated ability to manage multiple projects and meet strict deadlines in a remote environment.
  • Ability to work independently and collaboratively within cross-functional teams.
This advertiser has chosen not to accept applicants from your region.

Remote Senior Pharmaceutical Regulatory Affairs Specialist

60400 Embu, Eastern KES195000 Annually WhatJobs

Posted 18 days ago

Job Viewed

Tap Again To Close

Job Description

full-time
Our client is a prominent pharmaceutical company seeking a highly qualified Senior Pharmaceutical Regulatory Affairs Specialist to join our expanding global regulatory team. This is a fully remote position, offering the flexibility to work from home. You will be responsible for ensuring compliance with all relevant regulatory requirements for drug development and marketing. Your duties will include preparing and submitting regulatory filings, liaising with health authorities, interpreting regulatory guidelines, and providing strategic advice to internal teams. The ideal candidate will have a deep understanding of pharmaceutical regulations in key markets, excellent scientific knowledge, and strong attention to detail. You will play a vital role in bringing life-saving medicines to patients worldwide. Responsibilities:
  • Prepare, review, and submit regulatory submissions (e.g., INDs, NDAs, MAAs) to health authorities globally.
  • Develop and implement regulatory strategies for drug development and lifecycle management.
  • Interpret and communicate complex regulatory guidelines and requirements to internal stakeholders.
  • Serve as the primary point of contact with regulatory agencies.
  • Review and approve labeling, promotional materials, and other product-related documents for regulatory compliance.
  • Monitor changes in the regulatory landscape and assess their impact on the company.
  • Provide regulatory input for clinical trial design and execution.
  • Manage post-approval regulatory activities, including variations and renewals.
  • Collaborate with R&D, manufacturing, quality assurance, and marketing teams.
  • Contribute to the development and implementation of departmental SOPs and policies.
Qualifications:
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life sciences field. A Master's degree or Pharm.D. is a plus.
  • Minimum of 6 years of experience in pharmaceutical regulatory affairs.
  • In-depth knowledge of regulatory requirements and submission processes in major markets (e.g., FDA, EMA, PMDA).
  • Experience with preparing and submitting various types of regulatory dossiers.
  • Strong understanding of drug development processes and GxP regulations.
  • Excellent written and verbal communication skills, with strong attention to detail.
  • Ability to work independently and manage multiple projects in a fast-paced environment.
  • Proficiency in regulatory information management systems is desirable.
  • Demonstrated ability to collaborate effectively with cross-functional teams and external partners.
  • Experience working in a remote setup, demonstrating strong organizational and time management skills.
This advertiser has chosen not to accept applicants from your region.

Remote Senior Pharmaceutical Regulatory Affairs Specialist

30200 Tuwan KES350000 Annually WhatJobs

Posted 20 days ago

Job Viewed

Tap Again To Close

Job Description

full-time
Our client, a leading pharmaceutical company, is seeking a highly experienced and meticulous Remote Senior Pharmaceutical Regulatory Affairs Specialist to join our global regulatory team. This position is fully remote, allowing you to manage regulatory submissions and strategies from anywhere. The ideal candidate will possess in-depth knowledge of international pharmaceutical regulations, submission processes, and health authority requirements. You will be responsible for ensuring compliance with all relevant regulatory guidelines, facilitating the approval of new drug applications, and maintaining the regulatory status of existing products.

Key Responsibilities:
  • Develop and implement regulatory strategies for product registration and lifecycle management in target markets.
  • Prepare, review, and submit regulatory dossiers (e.g., CTD, IND, NDA, ANDA) to health authorities worldwide.
  • Liaise with regulatory agencies, respond to queries, and ensure timely resolution of regulatory issues.
  • Interpret and provide guidance on regulatory requirements and changes to internal teams.
  • Conduct regulatory intelligence activities to stay abreast of evolving global regulations.
  • Manage post-approval changes and ensure compliance with marketing authorizations.
  • Collaborate with R&D, clinical operations, manufacturing, and quality assurance teams to support regulatory submissions.
  • Assess the regulatory impact of proposed product changes and development plans.
  • Develop and maintain regulatory documentation and databases.
  • Contribute to the development of regulatory policies and procedures.
  • Provide strategic regulatory input during product development and commercialization phases.
  • Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP) where applicable to regulatory submissions.
Qualifications:
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life sciences field. Advanced degree (MSc, PhD) or PharmD is preferred.
  • Minimum of 7 years of experience in pharmaceutical regulatory affairs.
  • Extensive experience with regulatory submissions in major markets (e.g., FDA, EMA, local authorities).
  • In-depth knowledge of ICH guidelines and regional regulatory requirements.
  • Proven ability to interpret and apply complex regulatory legislation.
  • Strong scientific understanding of drug development and manufacturing processes.
  • Excellent written and verbal communication skills, with strong attention to detail.
  • Proficiency in regulatory information management systems and submission software.
  • Demonstrated ability to work independently, manage multiple projects, and meet tight deadlines in a remote setting.
  • Strong analytical and problem-solving skills.
This crucial remote role supports our client's global pharmaceutical operations, with a focus on regulatory compliance for products associated with Eldoret, Uasin Gishu, KE . If you are a seasoned regulatory expert looking for a challenging remote opportunity, we encourage you to apply.
This advertiser has chosen not to accept applicants from your region.

Remote Senior Pharmaceutical Regulatory Affairs Specialist

80100 Nairobi, Nairobi KES150000 Annually WhatJobs

Posted 10 days ago

Job Viewed

Tap Again To Close

Job Description

full-time
Our client is seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their fully remote team. This critical role involves navigating the complex landscape of pharmaceutical regulations to ensure our products meet all necessary compliance requirements for market entry and distribution globally. The ideal candidate will possess a comprehensive understanding of drug development, clinical trials, and the regulatory submission processes across key international markets (e.g., FDA, EMA, WHO). You will be responsible for preparing, reviewing, and submitting regulatory dossiers, responding to regulatory authority inquiries, and advising R&D and commercial teams on regulatory strategies. This position requires meticulous attention to detail, exceptional analytical skills, and the ability to interpret and apply intricate regulatory guidelines. Collaboration with internal stakeholders, including legal, R&D, and marketing departments, will be essential to align regulatory strategies with business objectives. The successful candidate will stay abreast of evolving regulatory landscapes and proactively identify potential challenges and opportunities. This is a significant opportunity for a seasoned professional to lead regulatory efforts in a dynamic, remote-first pharmaceutical company. We are committed to fostering a work environment that values expertise, collaboration, and innovation. Responsibilities:
  • Develop and implement global regulatory strategies for pharmaceutical products.
  • Prepare, review, and submit regulatory submissions (e.g., INDs, NDAs, CTAs).
  • Liaise with regulatory health authorities worldwide.
  • Ensure compliance with all applicable pharmaceutical regulations and guidelines.
  • Advise project teams on regulatory requirements throughout the product lifecycle.
  • Monitor and interpret changes in global pharmaceutical regulations.
  • Conduct regulatory intelligence gathering and analysis.
  • Manage post-approval regulatory activities, including lifecycle management.
  • Review and approve labeling and promotional materials for regulatory compliance.
  • Contribute to the development of SOPs and internal regulatory policies.

Qualifications:
  • Master's degree or Pharm.D. in Pharmacy, Life Sciences, or a related field.
  • Extensive experience in pharmaceutical regulatory affairs.
  • In-depth knowledge of global pharmaceutical regulatory requirements and submission processes.
  • Proven track record of successful regulatory submissions.
  • Strong analytical, strategic thinking, and problem-solving skills.
  • Excellent written and verbal communication skills.
  • Ability to work independently, manage projects effectively, and meet strict deadlines in a remote setting.
  • Experience with regulatory information management systems is a plus.
  • Familiarity with different therapeutic areas is advantageous.
This advertiser has chosen not to accept applicants from your region.

Remote Senior Pharmaceutical Regulatory Affairs Specialist

60300 Meru , Eastern KES195000 Annually WhatJobs

Posted 9 days ago

Job Viewed

Tap Again To Close

Job Description

full-time
Our client is seeking a highly accomplished and detail-oriented Senior Pharmaceutical Regulatory Affairs Specialist to join their fully remote team. This role is crucial for ensuring that all pharmaceutical products meet the rigorous requirements of regulatory agencies worldwide. You will be responsible for preparing, submitting, and managing regulatory dossiers, ensuring compliance with global regulations, and serving as a key liaison with health authorities. The ideal candidate will possess a profound understanding of pharmaceutical development, manufacturing processes, and the complex regulatory landscape. You will guide product development teams on regulatory strategies, conduct regulatory intelligence assessments, and contribute to the lifecycle management of pharmaceutical products. This is an exceptional opportunity to influence global drug development and market access from a remote setting.

Responsibilities:
  • Prepare, review, and submit regulatory submissions (e.g., INDs, NDAs, MAAs, variations) to health authorities globally.
  • Ensure compliance of pharmaceutical products and processes with current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and other relevant regulations.
  • Develop and implement global regulatory strategies for new product development and lifecycle management.
  • Serve as the primary point of contact with regulatory agencies during submissions and review processes.
  • Conduct regulatory intelligence activities to stay informed of evolving regulations and guidelines.
  • Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and quality assurance.
  • Manage post-approval regulatory commitments and ensure timely reporting.
  • Evaluate proposed changes to product labeling, manufacturing processes, and specifications for regulatory impact.
  • Participate in regulatory inspections and respond to agency queries.
  • Develop and maintain regulatory documentation and databases.
  • Contribute to the continuous improvement of regulatory affairs processes and best practices.
Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, Biotechnology, or a related life science field.
  • Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
  • In-depth knowledge of global pharmaceutical regulatory requirements (e.g., FDA, EMA, ICH guidelines).
  • Proven experience in preparing and submitting various types of regulatory dossiers.
  • Strong understanding of drug development, manufacturing, and quality assurance principles.
  • Excellent analytical, communication, and negotiation skills.
  • Ability to manage complex projects, prioritize effectively, and meet critical deadlines in a remote environment.
  • Demonstrated experience in regulatory strategy development and execution.
  • Proficiency in regulatory information management systems is a plus.
  • Experience with international markets and diverse regulatory submission types.
This is a fully remote role, with a strategic oversight that may relate to operations or market access in regions like **Meru, Meru**. Our client offers a competitive remuneration package, comprehensive benefits, and the opportunity to significantly contribute to bringing vital pharmaceutical products to patients worldwide.
This advertiser has chosen not to accept applicants from your region.

Remote Senior Pharmaceutical Regulatory Affairs Specialist

50200 Bungoma, Western KES275000 Annually WhatJobs

Posted 9 days ago

Job Viewed

Tap Again To Close

Job Description

full-time
Our client, a leading global pharmaceutical company, is seeking a highly knowledgeable and experienced Remote Senior Pharmaceutical Regulatory Affairs Specialist. This fully remote role is critical for ensuring compliance with regulatory requirements for pharmaceutical products across various markets. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and providing strategic guidance on regulatory submissions and strategy. Your expertise will be crucial in navigating the complex landscape of pharmaceutical regulations, including drug registration, clinical trial approvals, and post-market surveillance. Key responsibilities include developing regulatory submission strategies, compiling dossiers for new drug applications (NDAs), variations, and renewals, and ensuring adherence to Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP). You will also monitor regulatory intelligence, assess the impact of new regulations, and advise project teams on compliance matters. The ideal candidate will possess a strong background in pharmaceutical sciences or a related field, extensive experience in regulatory affairs within the pharmaceutical industry, and a deep understanding of global regulatory guidelines (e.g., FDA, EMA, WHO). Excellent written and verbal communication skills are essential for effectively interacting with health authorities and internal stakeholders in a remote setting. Proficiency in regulatory information management systems is also highly desirable. This is an outstanding opportunity for a dedicated regulatory affairs professional to contribute to vital pharmaceutical development and market access, all while benefiting from a fully remote work arrangement. You will be instrumental in bringing life-saving medications to patients worldwide. Responsibilities include:
  • Developing and implementing regulatory submission strategies for pharmaceutical products.
  • Preparing, reviewing, and submitting regulatory dossiers (e.g., CTD, IND, NDA).
  • Communicating and negotiating with global health authorities.
  • Ensuring compliance with pharmaceutical regulations, guidelines, and standards.
  • Monitoring regulatory intelligence and assessing the impact of changes.
  • Providing regulatory guidance and support to R&D, clinical, and manufacturing teams.
  • Managing the lifecycle of regulatory approvals, including variations and renewals.
  • Conducting regulatory risk assessments and developing mitigation plans.
  • Contributing to the development of labeling and promotional materials.
  • Maintaining regulatory documentation and databases.
This advertiser has chosen not to accept applicants from your region.

Remote Senior Pharmaceutical Regulatory Affairs Specialist

90100 Gathiruini KES7000000 Annually WhatJobs

Posted 17 days ago

Job Viewed

Tap Again To Close

Job Description

full-time
Our client, a dynamic and innovative pharmaceutical company, is actively seeking a Senior Pharmaceutical Regulatory Affairs Specialist to join their global, fully remote team. This crucial role involves ensuring compliance with all applicable regulatory requirements for the development, manufacturing, and marketing of pharmaceutical products. You will be responsible for preparing, submitting, and managing regulatory filings with health authorities worldwide, including but not limited to, the FDA, EMA, and other national agencies. The ideal candidate will possess a profound understanding of drug development processes, GMP, GCP, and GLP guidelines, as well as a comprehensive knowledge of global regulatory landscapes and submission strategies. Your expertise will be vital in interpreting complex regulatory guidelines, advising project teams on regulatory strategy, and conducting regulatory intelligence activities to stay ahead of evolving requirements. Responsibilities include leading cross-functional teams through the regulatory submission process, responding to regulatory agency queries, and ensuring the maintenance of product registrations and licenses. Strong analytical, organizational, and communication skills are essential, as you will be interacting with internal stakeholders at all levels, as well as external regulatory bodies. This is a remote-first position, offering significant flexibility and the opportunity to work collaboratively with international teams using advanced digital platforms. You will play a key role in bringing life-saving and life-enhancing medicines to patients globally. A commitment to meticulous documentation, strategic planning, and proactive problem-solving is paramount. If you are a seasoned regulatory professional with a passion for pharmaceutical innovation and a desire to contribute to global health from a remote setting, we encourage you to apply.
Responsibilities:
  • Develop and implement global regulatory strategies for pharmaceutical products.
  • Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs) to health authorities.
  • Manage and maintain product registrations and lifecycle regulatory activities.
  • Interpret and apply global regulatory guidelines and requirements.
  • Provide regulatory guidance and support to R&D, manufacturing, and commercial teams.
  • Conduct regulatory intelligence and competitor analysis.
  • Respond to queries from regulatory agencies and facilitate agency inspections.
  • Ensure compliance with relevant pharmaceutical regulations, GMP, GCP, and GLP.
  • Lead regulatory project teams and contribute to strategic decision-making.
  • Maintain strong relationships with regulatory authorities and industry associations.
Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
  • Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
  • In-depth knowledge of global regulatory requirements and submission processes (e.g., ICH, FDA, EMA).
  • Proven experience in preparing and submitting various types of regulatory applications.
  • Strong understanding of drug development, manufacturing, and quality systems.
  • Excellent analytical, problem-solving, and strategic thinking skills.
  • Exceptional written and verbal communication and interpersonal skills.
  • Ability to manage multiple projects simultaneously in a fast-paced, remote environment.
  • Experience working with cross-functional teams and external regulatory bodies.
This advertiser has chosen not to accept applicants from your region.
Be The First To Know

About the latest Remote senior pharmaceutical regulatory affairs specialist Jobs in Kenya !

Nearby Locations

Other Jobs Near Me

Industry

  1. request_quote Accounting
  2. work Administrative
  3. eco Agriculture Forestry
  4. smart_toy AI & Emerging Technologies
  5. school Apprenticeships & Trainee
  6. apartment Architecture
  7. palette Arts & Entertainment
  8. directions_car Automotive
  9. flight_takeoff Aviation
  10. account_balance Banking & Finance
  11. local_florist Beauty & Wellness
  12. restaurant Catering
  13. volunteer_activism Charity & Voluntary
  14. science Chemical Engineering
  15. child_friendly Childcare
  16. foundation Civil Engineering
  17. clean_hands Cleaning & Sanitation
  18. diversity_3 Community & Social Care
  19. construction Construction
  20. brush Creative & Digital
  21. currency_bitcoin Crypto & Blockchain
  22. support_agent Customer Service & Helpdesk
  23. medical_services Dental
  24. medical_services Driving & Transport
  25. medical_services E Commerce & Social Media
  26. school Education & Teaching
  27. electrical_services Electrical Engineering
  28. bolt Energy
  29. local_mall Fmcg
  30. gavel Government & Non Profit
  31. emoji_events Graduate
  32. health_and_safety Healthcare
  33. beach_access Hospitality & Tourism
  34. groups Human Resources
  35. precision_manufacturing Industrial Engineering
  36. security Information Security
  37. handyman Installation & Maintenance
  38. policy Insurance
  39. code IT & Software
  40. gavel Legal
  41. sports_soccer Leisure & Sports
  42. inventory_2 Logistics & Warehousing
  43. supervisor_account Management
  44. supervisor_account Management Consultancy
  45. supervisor_account Manufacturing & Production
  46. campaign Marketing
  47. build Mechanical Engineering
  48. perm_media Media & PR
  49. local_hospital Medical
  50. local_hospital Military & Public Safety
  51. local_hospital Mining
  52. medical_services Nursing
  53. local_gas_station Oil & Gas
  54. biotech Pharmaceutical
  55. checklist_rtl Project Management
  56. shopping_bag Purchasing
  57. home_work Real Estate
  58. person_search Recruitment Consultancy
  59. store Retail
  60. point_of_sale Sales
  61. science Scientific Research & Development
  62. wifi Telecoms
  63. psychology Therapy
  64. pets Veterinary
View All Remote Senior Pharmaceutical Regulatory Affairs Specialist Jobs