Senior Regulatory Affairs Specialist - Pharmaceuticals

Placements24; Cape Town; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Competitive salary

Hybrid work flexibility

Comprehensive medical insurance

Retirement fund benefits

Professional development & training

Annual bonus potential

Vacation & public holidays

Healthcare initiatives

Industry conferences & networking

Job summary

Placements24 is seeking a Senior Regulatory Affairs Specialist in Cape Town, Western Cape, SA to ensure compliance with national and international regulations, prepare and submit regulatory dossiers, and liaise with SAHPRA, FDA, and EMA as required.

The role requires a Pharmacy/Life Sciences degree and at least 6 years of regulatory experience, with strong writing and project management skills. Hybrid work includes on-site collaboration at the Cape Town office and remote work when feasible.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or life science.
• Minimum of 6 years of Regulatory Affairs experience in the pharmaceutical industry.
• Understanding of global regulatory requirements and CTD submissions.
• Experience with preparing and submitting regulatory dossiers.

Responsibilities

• Prepare, review, and submit regulatory dossiers for NDAs, variations, and renewals.
• Liaise with SAHPRA, FDA, EMA, and other authorities as required.
• Interpret regulatory requirements for internal teams and provide guidance.
• Develop regulatory strategies to support product development and lifecycle management.
• Monitor regulatory changes and maintain compliance.
• Support labeling, advertising, and promotional materials with regulatory input.
• Conduct regulatory intelligence and competitor analysis.
• Participate in inspections and respond to queries.
• Collaborate with R&D, Clinical, Marketing, and Manufacturing teams.
• Update regulatory databases and documentation timely.

Skills

Regulatory expertise

Project management

Communication skills

Education

Bachelor's degree in Pharmacy/ Chemistry/ Biology

Job description

About the Role

Our client, a dynamic player in the Pharmaceutical sector, is seeking a meticulous and experienced Senior Regulatory Affairs Specialist to join their team in Cape Town, Western Cape, ZA . This role is pivotal in ensuring that our client's products comply with all relevant national and international regulatory requirements, facilitating timely product approvals and market access. The position involves preparing and submitting regulatory dossiers, liaising with health authorities, and staying abreast of evolving regulatory landscapes. This role adopts a hybrid work model, blending remote work with essential on-site collaboration at our Cape Town office. The ideal candidate has a comprehensive understanding of pharmaceutical regulations and a proven ability to navigate complex submission processes. You will be a key contributor to our client's success by ensuring adherence to the highest standards of regulatory compliance within the Pharmaceutical industry. Your expertise will be crucial in bringing innovative treatments to patients efficiently and safely.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers for new drug applications (NDAs), variations, and renewals.
• Liaise with regulatory authorities such as SAHPRA, FDA, EMA, and others as required.
• Interpret and communicate regulatory requirements and guidelines to internal teams.
• Develop regulatory strategies to support product development and lifecycle management.
• Maintain regulatory compliance by monitoring changes in regulations and guidelines.
• Provide regulatory input and support for product labeling, advertising, and promotional materials.
• Conduct regulatory intelligence gathering and competitor analysis.
• Participate in regulatory inspections and respond to authority queries.
• Collaborate with cross-functional teams including R&D, Clinical Affairs, Marketing, and Manufacturing.
• Ensure timely and accurate updates to regulatory databases and documentation.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
• Minimum of 6 years of experience in Regulatory Affairs within the Pharmaceutical industry.
• Thorough understanding of global pharmaceutical regulatory requirements and submission processes (e.g., CTD format).
• Proven experience in preparing and submitting various types of regulatory dossiers.
• Excellent analytical, organizational, and problem-solving skills.
• Strong written and verbal communication skills, with keen attention to detail.
• Ability to work independently and manage multiple projects in a deadline-driven environment.
• Experience with hybrid work arrangements is preferred.
• Familiarity with the South African regulatory landscape (SAHPRA) is advantageous.
• Based in or willing to relocate to the Cape Town area.

Benefits

• Competitive annual salary of ZAR.
• Hybrid work flexibility.
• Comprehensive medical insurance coverage.
• Retirement fund benefits.
• Opportunities for professional development and international training.
• Annual bonus potential based on performance.
• Stimulating work environment within a growing Pharmaceutical company.
• Paid vacation and public holidays.
• Contribution to healthcare initiatives.
• Access to industry conferences and networking events.