21 Senior Pharmaceutical Regulatory Affairs Specialist Remote jobs in whatjobs
Senior Pharmaceutical Regulatory Affairs Specialist (Remote)
Posted 20 days ago
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Job Description
Key Responsibilities:
- Develop and execute global regulatory strategies for pharmaceutical product development and lifecycle management.
- Prepare, review, and submit regulatory documentation (e.g., INDs, NDAs, MAAs, CTAs) to health authorities worldwide.
- Serve as the primary point of contact for regulatory agencies, responding to queries and managing submissions.
- Monitor and interpret evolving regulatory guidelines, legislation, and trends impacting the pharmaceutical industry.
- Assess regulatory requirements for new product development, clinical trials, and post-approval changes.
- Provide regulatory guidance and support to cross-functional teams, including R&D, clinical, manufacturing, and marketing.
- Ensure company compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Pharmacovigilance Practice (GVP).
- Manage and maintain regulatory databases and documentation systems.
- Participate in regulatory audits and inspections.
- Contribute to the development and improvement of internal regulatory processes and SOPs.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life sciences field. A Master's degree or Ph.D. is a plus.
- Minimum of 7 years of experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting regulatory dossiers to major health authorities (e.g., FDA, EMA, MHRA).
- In-depth knowledge of pharmaceutical development processes, regulatory pathways, and global compliance requirements.
- Excellent understanding of ICH guidelines and other relevant international regulatory standards.
- Strong analytical, critical thinking, and problem-solving skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex regulatory issues clearly.
- Experience working effectively in a fully remote, collaborative team environment.
- Detail-oriented with strong organizational and project management abilities.
- Experience in specific therapeutic areas is an advantage.
Senior Pharmaceutical Regulatory Affairs Specialist - Remote
Posted 20 days ago
Job Viewed
Job Description
Responsibilities:
- Prepare, review, and submit high-quality regulatory dossiers for new drug applications (NDAs), variations, and renewals.
- Interpret and advise on global regulatory requirements and guidelines (e.g., FDA, EMA, ICH).
- Serve as the primary point of contact with regulatory agencies, managing communications and submissions.
- Develop and implement regulatory strategies to support product development and commercialization.
- Conduct regulatory intelligence activities to stay informed of evolving regulations and competitor landscape.
- Ensure compliance with all applicable regulations and company policies throughout the product lifecycle.
- Collaborate closely with R&D, clinical, manufacturing, and quality assurance teams.
- Manage post-approval regulatory commitments and life-cycle management activities.
- Lead regulatory interactions, including meetings and teleconferences with health authorities.
- Mentor and guide junior regulatory affairs professionals.
Qualifications:
- Master's degree or Ph.D. 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 regulatory submission processes and guidelines in major markets (e.g., US, EU, Canada, Japan).
- Proven experience in preparing and managing various types of regulatory submissions.
- Strong understanding of drug development processes, GMP, GCP, and GLP.
- Excellent analytical, problem-solving, and strategic thinking skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
- Demonstrated ability to work independently, manage multiple complex projects, and meet strict deadlines in a remote setting.
- Proficiency in regulatory information management systems is a plus.
- Strong interpersonal skills and the ability to work effectively in a global, cross-functional team.
This is a significant opportunity for an experienced regulatory affairs professional to contribute to groundbreaking pharmaceutical advancements, working remotely and impacting global health, with a specific focus on regulatory pathways relevant to the pharmaceutical landscape around Bungoma, Bungoma, KE .
Senior Pharmaceutical Regulatory Affairs Specialist (Remote)
Posted 20 days ago
Job Viewed
Job Description
The ideal candidate will possess a deep understanding of global pharmaceutical regulations, including submission requirements for various health authorities (e.g., FDA, EMA, PPB). You will be responsible for developing regulatory strategies, preparing and submitting regulatory dossiers, and ensuring compliance throughout the product lifecycle. This role requires exceptional attention to detail, strong analytical skills, and the ability to navigate complex regulatory landscapes.
Key responsibilities include:
- Developing and implementing comprehensive regulatory affairs strategies for drug development and lifecycle management.
- Preparing, reviewing, and submitting regulatory applications and dossiers to health authorities worldwide.
- Ensuring all regulatory activities and submissions are in compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).
- Interfacing with regulatory agencies, responding to queries, and managing communications throughout the submission and approval process.
- Monitoring changes in global regulatory requirements and assessing their impact on the company's products and strategies.
- Collaborating with R&D, clinical, manufacturing, and commercial teams to provide regulatory guidance and support.
- Managing post-approval regulatory activities, including annual reports and variations.
- Conducting regulatory intelligence gathering and analysis.
- Reviewing promotional materials for regulatory compliance.
- Participating in regulatory audits and inspections.
- Developing and maintaining strong relationships with key regulatory stakeholders.
- Mentoring junior regulatory affairs professionals.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 5-7 years of experience in pharmaceutical regulatory affairs.
- Proven track record of successful regulatory submissions and approvals.
- In-depth knowledge of international regulatory guidelines and submission requirements (e.g., ICH, FDA, EMA).
- Familiarity with drug development processes and lifecycles.
- Excellent written and verbal communication skills, with the ability to clearly articulate complex regulatory information.
- Strong analytical, problem-solving, and organizational skills.
- Ability to work independently and manage multiple projects in a remote environment.
- Proficiency in regulatory information management systems and standard office software.
- Experience with both generic and innovative drug products is a plus.
Senior Pharmaceutical Regulatory Affairs Specialist (Remote)
Posted 20 days ago
Job Viewed
Job Description
Key Responsibilities:
- Develop and implement regulatory strategies for new and existing pharmaceutical products.
- Prepare, review, and submit regulatory dossiers to health authorities worldwide (e.g., FDA, EMA, Kenya NRB).
- Serve as the primary point of contact with regulatory agencies during submission processes.
- Interpret and communicate complex regulatory requirements and guidance documents to internal stakeholders.
- Ensure compliance with all applicable pharmaceutical regulations, guidelines, and standards.
- Collaborate with R&D, Quality, Clinical, and Manufacturing teams to gather necessary information for submissions.
- Manage post-approval regulatory activities, including amendments, supplements, and renewals.
- Conduct regulatory intelligence activities to stay updated on global regulatory trends and changes.
- Provide regulatory input and support for product development, lifecycle management, and marketing activities.
- Assess the regulatory impact of proposed product changes and manufacturing processes.
- Develop and deliver regulatory training to internal teams.
- Participate in regulatory inspections and audits.
- Contribute to the continuous improvement of regulatory processes and systems.
- Evaluate and advise on the regulatory feasibility of new business development opportunities.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life sciences field. A Master's degree or relevant professional certification (e.g., RAC) is highly desirable.
- Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs.
- Proven experience with global regulatory submissions (e.g., NDAs, ANDAs, MAAs).
- In-depth knowledge of ICH guidelines and regional regulatory requirements (e.g., US, EU, Africa).
- Strong understanding of drug development, manufacturing, and quality systems.
- Excellent analytical, problem-solving, and critical thinking skills.
- Outstanding written and verbal communication skills, with the ability to present complex information clearly.
- Exceptional organizational and project management skills.
- Ability to work independently, manage multiple priorities, and meet strict deadlines in a remote setting.
- Proficiency in regulatory information management systems and databases.
- High ethical standards and a commitment to compliance.
Senior Pharmaceutical Regulatory Affairs Specialist - Remote
Posted 20 days ago
Job Viewed
Job Description
Responsibilities:
- Develop and execute global regulatory strategies for pharmaceutical products.
- Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs, variations) to health authorities.
- Serve as a key point of contact for regulatory agencies worldwide.
- Interpret and advise on regulatory requirements and guidelines.
- Manage regulatory submissions throughout their lifecycle, including post-approval changes.
- Collaborate with internal departments (R&D, QA, Manufacturing, Clinical) to ensure regulatory compliance.
- Monitor regulatory intelligence and industry trends, communicating impact to the organization.
- Provide guidance on labeling, advertising, and promotional materials.
- Contribute to regulatory aspects of due diligence for potential acquisitions or partnerships.
- Maintain regulatory compliance for marketed products.
- 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.
- In-depth knowledge of ICH guidelines and major regulatory agency requirements (FDA, EMA, etc.).
- Proven experience in preparing and submitting major regulatory applications.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong project management and organizational abilities, particularly in a remote context.
- Superior written and verbal communication skills for effective stakeholder interaction.
- Ability to work independently and as part of a distributed global team.
- Experience with electronic submission systems and regulatory information management (RIM) software.
Senior Pharmaceutical Regulatory Affairs Specialist - Remote
Posted 20 days ago
Job Viewed
Job Description
Responsibilities:
- Develop and implement global regulatory strategies for product development and lifecycle management.
- Prepare, review, and submit high-quality regulatory dossiers (e.g., CTD, IND, NDA) to health authorities worldwide.
- Serve as the primary regulatory contact for assigned projects and products.
- Respond to questions and requests from regulatory agencies.
- Monitor and interpret evolving regulatory guidelines and legislation impacting the pharmaceutical industry.
- Provide regulatory guidance and support to R&D, Quality, and Commercial teams.
- Assess the regulatory impact of proposed changes to product manufacturing, labeling, and marketing.
- Ensure compliance with all applicable GMP, GCP, and GLP regulations.
- Manage post-approval regulatory activities, including supplements and variations.
- Maintain regulatory documentation and databases.
- Contribute to the continuous improvement of regulatory processes and systems.
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline; Master's degree or Pharm.D. is a plus.
- Minimum of 5 years of progressive experience in pharmaceutical regulatory affairs.
- Comprehensive knowledge of global regulatory submission requirements and guidelines (e.g., FDA, EMA, ICH).
- Proven experience in preparing and submitting major regulatory filings.
- Excellent understanding of drug development processes and pharmaceutical manufacturing.
- Strong analytical, problem-solving, and strategic thinking skills.
- Exceptional written and verbal communication skills, with a high degree of accuracy.
- Ability to work independently and manage multiple priorities in a remote setting.
- Detail-oriented with strong organizational skills.
Senior Pharmaceutical Regulatory Affairs Specialist (Remote)
Posted 20 days ago
Job Viewed
Job Description
Key Responsibilities:
- Develop and implement regulatory strategies for product development, registration, and lifecycle management.
- Prepare, review, and submit regulatory dossiers (e.g., CTD, IND, NDA, MAA) to health authorities in various global markets.
- Interpret and advise on complex regulatory requirements, guidelines, and legislation impacting pharmaceutical products.
- Liaise directly with regulatory agencies (e.g., KEBS, FDA, EMA) to facilitate the approval process and address inquiries.
- Ensure that all company activities and products comply with current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
- Manage post-approval regulatory activities, including variations, renewals, and annual reports.
- Conduct regulatory intelligence gathering to stay abreast of emerging trends and changes in the regulatory landscape.
- Collaborate with cross-functional teams (R&D, Clinical, Manufacturing, Quality Assurance) to provide regulatory input and support.
- Assess the regulatory implications of product changes, manufacturing processes, and labeling.
- Contribute to the development and implementation of departmental SOPs and policies.
Qualifications:
- Minimum of 8 years of experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting successful regulatory submissions for various product types.
- In-depth knowledge of global pharmaceutical regulations and guidelines (e.g., ICH, FDA, EMA, KEBS).
- Strong understanding of drug development processes, manufacturing, and quality systems.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with a talent for concise and accurate documentation.
- Ability to manage multiple projects simultaneously and meet strict deadlines.
- Experience working in a remote or virtual team environment is highly desirable.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree or Pharm.D. is preferred.
- Proficiency in regulatory information management systems.
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Senior Pharmaceutical Regulatory Affairs Specialist - Remote
Posted 20 days ago
Job Viewed
Job Description
Responsibilities:
- Develop and execute global regulatory strategies for new drug applications (NDAs), abbreviated new drug applications (ANDAs), and variations.
- Prepare, review, and submit high-quality regulatory dossiers (e.g., CTD, eCTD) to health authorities worldwide.
- Serve as a key point of contact with regulatory agencies, responding to inquiries and addressing deficiencies.
- Monitor and interpret global regulatory guidelines and provide strategic advice to internal teams.
- Conduct regulatory intelligence activities to stay abreast of emerging trends and requirements.
- Collaborate with cross-functional teams (e.g., R&D, Clinical, Manufacturing, Quality Assurance) to ensure regulatory compliance throughout the product lifecycle.
- Manage post-approval regulatory activities, including annual reports, supplements, and labeling changes.
- Review promotional and advertising materials for regulatory compliance.
- Contribute to the development of regulatory policies and procedures.
- Lead and mentor junior regulatory affairs professionals.
- Ensure timely communication of regulatory updates and potential risks to stakeholders.
- Support regulatory due diligence for business development activities.
- 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, CTD/eCTD format, and specific regional regulatory requirements.
- Strong analytical, problem-solving, and strategic planning skills.
- Excellent written and verbal communication skills, with the ability to clearly articulate complex regulatory information.
- Experience working independently and managing multiple complex projects in a remote setting.
- Proficiency with regulatory information management (RIM) systems and eCTD publishing software.
- Ability to build effective working relationships with regulatory agencies and internal stakeholders.
- High level of integrity and attention to detail.
Senior Pharmaceutical Regulatory Affairs Specialist - Remote
Posted 20 days ago
Job Viewed
Job Description
Key Responsibilities:
- Develop and execute regulatory strategies for product registration and lifecycle management in target markets.
- Prepare, review, and submit regulatory documentation (e.g., dossiers, applications, amendments) to health authorities.
- Interpret and apply national and international pharmaceutical regulations, guidelines, and standards.
- Liaise with regulatory agencies to facilitate product approvals and address regulatory inquiries.
- Provide regulatory guidance and support to cross-functional teams, including R&D, clinical, manufacturing, and marketing.
- Conduct regulatory intelligence activities to stay informed about evolving regulatory requirements and industry trends.
- Assess the regulatory implications of product changes, manufacturing processes, and labeling updates.
- Manage post-approval regulatory obligations and ensure ongoing compliance.
- Participate in regulatory audits and inspections, both internal and external.
- Contribute to the development and implementation of regulatory affairs policies and procedures.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
- Minimum of 7 years of experience in pharmaceutical regulatory affairs.
- Proven track record of successful regulatory submissions and approvals.
- In-depth knowledge of pharmaceutical regulatory frameworks (e.g., ICH, FDA, EMA guidelines) and local Kenyan regulations.
- Strong understanding of drug development processes, Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP).
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
- Proficiency in regulatory information management systems and electronic submission tools.
- Ability to work independently, manage multiple projects, and meet tight deadlines in a remote environment.
- Strong negotiation and influencing skills when interacting with health authorities.
This remote opportunity provides a challenging and rewarding career path for a seasoned regulatory professional eager to impact pharmaceutical accessibility and compliance within the **Mlolongo, Machakos, KE** region and beyond.
Senior Pharmaceutical Regulatory Affairs Specialist (Remote)
Posted 20 days ago
Job Viewed
Job Description
- Developing and implementing regulatory strategies for new and existing pharmaceutical products.
- Preparing, reviewing, and submitting regulatory dossiers (e.g., CTD, IND, NDA) to health authorities globally.
- Interpreting and advising on relevant pharmaceutical regulations, guidelines, and standards.
- Managing regulatory lifecycle activities, including post-approval changes and renewals.
- Liaising with regulatory agencies, responding to inquiries, and facilitating meetings.
- Conducting regulatory intelligence activities to stay informed about evolving requirements.
- Providing regulatory support for product development, manufacturing, and marketing.
- Ensuring compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP).
- Reviewing promotional materials for regulatory compliance.
Qualifications:
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline. A Master's or PhD is a plus.
- Minimum of 6 years of experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global regulatory submission processes and requirements (e.g., FDA, EMA, WHO).
- Proven experience in preparing and submitting various types of regulatory dossiers.
- Familiarity with pharmaceutical product development, manufacturing, and quality systems.
- Strong understanding of relevant scientific principles and regulatory guidelines.
- Excellent written and verbal communication skills, with strong attention to detail.
- Ability to manage multiple projects, prioritize tasks, and meet tight deadlines in a remote setting.