3 Senior Pharmaceutical Regulatory Affairs Manager jobs in whatjobs
Senior Pharmaceutical Regulatory Affairs Manager
Posted 20 days ago
Job Viewed
Job Description
Our client, a pioneering pharmaceutical company dedicated to developing life-changing therapies, is seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Manager to join their esteemed, fully remote team. This critical role will lead regulatory strategy and execution for a portfolio of innovative drug products, ensuring compliance with global health authority requirements. You will be responsible for interpreting complex regulatory guidelines, developing submission strategies, and managing the preparation and filing of regulatory documents for new drug applications (NDAs), supplemental NDAs, and other regulatory submissions. The ideal candidate will possess a deep understanding of pharmaceutical development, manufacturing, and regulatory science, coupled with a proven ability to navigate diverse international regulatory landscapes. As a remote-first leader, you will collaborate extensively with cross-functional teams, including R&D, clinical operations, quality assurance, and manufacturing, in a virtual setting. Your expertise in communicating effectively with regulatory agencies and advocating for the company's positions will be paramount. This position requires a proactive, detail-oriented professional with exceptional organizational and project management skills, capable of driving regulatory milestones within tight timelines. You will play a key role in shaping regulatory strategies, advising project teams on regulatory compliance, and ensuring that all activities meet the highest standards of scientific integrity and regulatory scrutiny. This is an unparalleled opportunity to contribute to bringing essential medicines to patients worldwide, leveraging the flexibility of a remote work environment while working for a globally recognized organization. The **location** for this role is considered to be Garissa, Garissa, KE , but the role is entirely remote.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Develop and implement global regulatory strategies for product development and lifecycle management.
- Manage the preparation, review, and submission of regulatory filings (e.g., INDs, NDAs, MAAs, variations) to health authorities worldwide.
- Serve as the primary regulatory contact for assigned projects, providing expert guidance and strategic input to cross-functional teams.
- Interpret and apply complex global regulatory requirements, guidelines, and policies.
- Conduct regulatory intelligence activities to monitor changes in the regulatory landscape and assess their impact.
- Lead regulatory agency interactions, including pre-submission meetings and responses to agency queries.
- Ensure compliance with all relevant regulations, including GMP, GCP, and GLP.
- Review and approve labeling, promotional materials, and other regulated product information.
- Develop and maintain strong relationships with key health authorities and external stakeholders.
- Mentor and guide junior regulatory affairs professionals.
Qualifications:
- Bachelor's degree in Pharmacy, Life Sciences, or a related scientific discipline. Advanced degree (M.S., Ph.D., Pharm.D.) is highly preferred.
- 8+ years of progressive experience in pharmaceutical regulatory affairs.
- Demonstrated success in preparing and submitting major regulatory filings (e.g., NDAs, MAAs) and achieving approvals.
- In-depth knowledge of global regulatory requirements (e.g., FDA, EMA, ICH guidelines).
- Strong understanding of drug development processes, from preclinical through commercialization.
- Excellent analytical, strategic thinking, and problem-solving skills.
- Exceptional written and verbal communication and presentation skills, with the ability to clearly articulate complex regulatory issues.
- Proven ability to manage multiple projects simultaneously and work effectively under pressure.
- Strong leadership and team collaboration skills, with experience working in a remote environment.
- Detail-oriented with a high level of accuracy and compliance.
This advertiser has chosen not to accept applicants from your region.
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Senior Pharmaceutical Regulatory Affairs Manager
Posted 10 days ago
Job Viewed
Job Description
Our client, a rapidly growing pharmaceutical innovator, is seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Manager to join our dedicated, fully remote team. This critical role will be responsible for leading regulatory strategies, ensuring compliance with global health authority regulations, and facilitating the timely approval of pharmaceutical products. You will play a key part in navigating the complex regulatory landscape, enabling us to bring life-saving and life-enhancing medications to patients.
Responsibilities:
Qualifications:
Responsibilities:
- Develop and execute comprehensive regulatory strategies for product development, registration, and lifecycle management.
- Interpret and apply global regulatory guidelines (e.g., FDA, EMA, ICH) to ensure compliance across all stages of drug development.
- Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs) to health authorities worldwide.
- Liaise directly with regulatory agencies, manage communications, and respond to agency queries.
- Provide regulatory guidance and support to R&D, clinical, manufacturing, and commercial teams.
- Assess regulatory risks and develop mitigation plans for product development and commercialization.
- Monitor regulatory changes and industry trends, advising the organization on potential impacts.
- Oversee post-approval regulatory activities, including supplements, variations, and annual reports.
- Manage regulatory submission timelines and ensure adherence to project milestones.
- Review and approve labeling, promotional materials, and advertising for regulatory compliance.
- Contribute to the development and implementation of departmental SOPs and best practices.
- Mentor and guide junior regulatory affairs professionals.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science discipline. A Ph.D. is a plus.
- A minimum of 8 years of progressive experience in pharmaceutical regulatory affairs.
- Proven track record of successful regulatory submissions and approvals.
- In-depth knowledge of global pharmaceutical regulatory requirements and guidelines.
- Experience with diverse therapeutic areas and dosage forms.
- Strong understanding of drug development processes, from preclinical to post-marketing.
- Excellent written and verbal communication skills, with the ability to negotiate and influence.
- Exceptional analytical and problem-solving abilities.
- Demonstrated ability to work independently, manage multiple projects, and meet tight deadlines in a remote setting.
- Experience with regulatory information management systems is beneficial.
- Strong leadership and team collaboration skills.
This advertiser has chosen not to accept applicants from your region.
1
Senior Pharmaceutical Regulatory Affairs Manager
Posted 1 day ago
Job Viewed
Job Description
Our client, a leading pharmaceutical innovator, is seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Manager to ensure compliance with global regulatory standards. This is a full-time, in-office position located in Nakuru, Nakuru, KE. The ideal candidate will possess a comprehensive understanding of regulatory submission processes, drug development lifecycle, and health authority requirements. You will be responsible for developing and implementing regulatory strategies, preparing and submitting regulatory dossiers (e.g., INDs, NDAs, MAAs), and managing post-approval regulatory activities. Key responsibilities include liaising with regulatory agencies, interpreting regulatory guidelines, and ensuring that all company products and processes meet stringent compliance requirements. You will work closely with R&D, clinical operations, quality assurance, and manufacturing teams to facilitate timely regulatory approvals and maintain compliance throughout the product lifecycle. This role demands exceptional analytical skills, strong leadership capabilities, and meticulous attention to detail. The ability to effectively communicate complex regulatory information to internal and external stakeholders is essential. We are looking for a seasoned regulatory affairs professional who can lead regulatory strategy, ensure compliance, and contribute to the successful market access of innovative pharmaceutical products. Your expertise will be critical in navigating the complex regulatory landscape and driving the company's product pipeline forward.
Responsibilities:
Responsibilities:
- Develop and execute global regulatory strategies for product development and registration.
- Prepare, review, and submit regulatory dossiers to health authorities worldwide (e.g., FDA, EMA, local agencies).
- Manage all aspects of the regulatory submission process, including pre-submission meetings and follow-ups.
- Ensure compliance with applicable pharmaceutical laws, regulations, and guidelines.
- Liaise effectively with regulatory agencies, responding to inquiries and addressing concerns.
- Monitor and interpret evolving regulatory requirements and trends.
- Provide regulatory guidance and support to cross-functional teams (R&D, Manufacturing, QA, Clinical).
- Oversee post-approval regulatory activities, including variations, renewals, and annual reports.
- Conduct regulatory due diligence for potential partnerships and acquisitions.
- Develop and maintain departmental Standard Operating Procedures (SOPs) related to regulatory affairs.
- Mentor and guide junior regulatory affairs professionals.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- 7+ years of progressive experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global regulatory submission requirements and processes.
- Proven experience in preparing and submitting various types of regulatory dossiers.
- Strong understanding of drug development lifecycle and relevant scientific principles.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with the ability to influence stakeholders.
- Experience in managing health authority interactions and inspections.
- Proficiency with regulatory information management systems is a plus.
- Strong leadership and team management capabilities.
- Ability to work effectively in a team-oriented environment and manage multiple priorities.
This advertiser has chosen not to accept applicants from your region.
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