7 Remote Senior Pharmaceutical Regulatory Affairs Specialist jobs in whatjobs
Remote Senior Pharmaceutical Regulatory Affairs Specialist
Posted 20 days ago
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Job Description
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.
- 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.
Remote Senior Pharmaceutical Regulatory Affairs Specialist
Posted 18 days ago
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Job Description
- 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.
- 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.
Remote Senior Pharmaceutical Regulatory Affairs Specialist
Posted 20 days ago
Job Viewed
Job Description
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.
- 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.
Remote Senior Pharmaceutical Regulatory Affairs Specialist
Posted 10 days ago
Job Viewed
Job Description
- 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.
Remote Senior Pharmaceutical Regulatory Affairs Specialist
Posted 9 days ago
Job Viewed
Job Description
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.
- 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.
Remote Senior Pharmaceutical Regulatory Affairs Specialist
Posted 9 days ago
Job Viewed
Job Description
- 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.
Remote Senior Pharmaceutical Regulatory Affairs Specialist
Posted 17 days ago
Job Viewed
Job Description
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.
- 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.
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