Pharmaceutical Regulatory Affairs Manager

Placements24; Paarl; Sur place; ZAR 1 200 000 - 1 800 000; Plein temps

Avantages offerts par ce poste

Salary package competitive

Medical aid

Retirement fund benefits

Leadership development opportunities

Résumé du poste

Placements24 is recruiting for a Regulatory Affairs Manager in Paarl, Western Cape to lead regulatory strategies and ensure compliance across global markets. The role oversees submissions, interactions with health authorities, and lifecycle management of products, demanding extensive regulatory experience and leadership.

The ideal candidate will have 8–10 years in pharmaceutical regulatory affairs, deep knowledge of GMP/GCP/GLP, ICH guidelines, and a proven track record in major market

Qualifications

• Master’s degree or PhD in a life science field.
• 8–10 years in pharmaceutical regulatory affairs.
• Proven track record with major regulatory approvals (FDA, EMA, SAHPRA).
• Strong knowledge of GMP, GCP, GLP and ICH guidelines.

Responsabilités

• Develop and implement regulatory strategies for product registration and lifecycle management in global markets.
• Prepare, review, and submit regulatory dossiers (CTD, NDA, ANDA) to health authorities.
• Serve as primary contact for regulatory agencies and manage communications.
• Ensure ongoing compliance with applicable regulations, guidelines and pharmacopoeias.
• Monitor regulatory changes and assess their impact on the portfolio.
• Lead and mentor the regulatory affairs team and liaise with cross-functional units.
• Collaborate with R&D, manufacturing, QA and legal.
• Oversee regulatory aspects of clinical trial applications and approvals.
• Manage post-approval variations, renewals and lifecycle maintenance.

Connaissances

Regulatory leadership

Strategic planning

Regulatory submissions

Team mentorship

Formation

Master's degree or PhD in Pharmacy/chemistry/biology

Description du poste

About the Role

Our client, a distinguished pharmaceutical organization, is actively seeking an accomplished Regulatory Affairs Manager to lead their regulatory strategies and ensure compliance from their offices in Paarl, Western Cape. This senior position is responsible for overseeing all aspects of regulatory submissions, interactions with health authorities, and ensuring that products meet all applicable legal and scientific requirements for market approval and maintenance. The ideal candidate will possess extensive experience in pharmaceutical regulatory affairs, a thorough understanding of global regulatory landscapes, and exceptional leadership capabilities. This is a key role for driving product lifecycle management and market access strategies within a highly respected company. Join our client's committed team in the scenic Paarl, Western Cape and play a pivotal role in bringing essential medicines to patients worldwide.

Key Responsibilities

• Develop and implement regulatory strategies for product registration and lifecycle management in various global markets.
• Prepare, review, and submit regulatory dossiers (e.g., CTD, NDA, ANDA) to health authorities worldwide.
• Serve as the primary point of contact for regulatory agencies, managing communications and responses.
• Ensure ongoing compliance with all applicable regulations, guidelines, and pharmacopoeias.
• Monitor changes in the regulatory environment and assess their impact on the company's portfolio.
• Lead and mentor the regulatory affairs team, fostering a culture of excellence and compliance.
• Collaborate with cross-functional teams including R&D, manufacturing, quality assurance, and legal.
• Oversee the regulatory aspects of clinical trial applications and approvals.
• Manage post-approval variations, renewals, and other lifecycle maintenance activities.

Requirements

• Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science discipline.
• Minimum of 8-10 years of progressive experience in pharmaceutical regulatory affairs.
• Proven track record of successful regulatory submissions and approvals in major markets (e.g., FDA, EMA, SAHPRA).
• In-depth knowledge of drug development processes, GMP, GCP, and GLP.
• Strong understanding of ICH guidelines and other relevant international regulatory frameworks.
• Excellent strategic thinking, leadership, and project management skills.
• Exceptional written and verbal communication skills, with strong negotiation abilities.
• Ability to work effectively in a team environment and manage multiple complex projects simultaneously.
• Experience working within the pharmaceutical industry in Paarl, Western Cape is highly desirable.

Benefits

Our client offers an attractive salary package, performance bonuses, comprehensive medical aid, retirement fund benefits, and ample opportunities for professional growth and leadership development. Employees benefit from working in a mission-driven organization dedicated to improving global health outcomes from the beautiful Paarl, Western Cape.