Senior Regulatory Affairs Specialist - Pharmaceuticals

Placements24; Stellenbosch; Hybride; ZAR 900 000 - 1 300 000; Plein temps

Avantages offerts par ce poste

Health insurance

Dental insurance

Vision insurance

Retirement plan

Résumé du poste

Placements24 in Stellenbosch is seeking a Senior Regulatory Affairs Specialist to ensure product compliance across lifecycle. You will prepare, submit, and manage regulatory dossiers and variations, liaising with SAHPRA and other health authorities to facilitate market approvals and renewals.

The role requires a Bachelor’s in Pharmacy or Life Sciences with 6+ years in regulatory affairs, plus strong ICH knowledge and strategic thinking to navigate complex compliance challenges in the South

Qualifications

• Bachelor’s degree in Pharmacy, Life Sciences, or related field.
• 6+ years of regulatory affairs experience in pharma.
• Strong knowledge of ICH and SAHPRA guidelines.
• Excellent communication and analytical skills.

Responsabilités

• Prepare and submit regulatory dossiers (CTD) for approvals, variations, renewals.
• Liaise with health authorities (SAHPRA, FDA, EMA) to address queries.
• Monitor regulatory changes and advise on impact on products.
• Provide regulatory guidance to R&D, Marketing, Manufacturing.
• Coordinate post-market surveillance and pharmacovigilance.

Connaissances

Regulatory strategy

Dossier submissions

Regulatory liaison

Regulatory analysis

Formation

Bachelor’s degree in Pharmacy/Life Sciences

Description du poste

About the Role

Our client is seeking an experienced Senior Regulatory Affairs Specialist to join their team in Stellenbosch . This critical role ensures that all pharmaceutical products comply with national and international regulatory requirements throughout their lifecycle. You will be responsible for preparing, submitting, and managing regulatory documentation for product approvals, variations, and renewals. The ideal candidate possesses a deep understanding of the regulatory landscape and is adept at navigating complex compliance issues to facilitate market access for innovative medicines.

Key Responsibilities

• Prepare and submit regulatory dossiers (e.g., CTD format) to health authorities, including applications for new drug approvals, variations, and renewals.
• Liaise with health authorities (e.g., SAHPRA, FDA, EMA) to respond to queries and facilitate the regulatory review process.
• Monitor changes in the regulatory environment and assess their impact on the company's products and strategies.
• Provide regulatory guidance to internal teams (e.g., R&D, Marketing, Manufacturing) to ensure compliance.
• Maintain regulatory compliance for assigned products throughout their lifecycle, including post-market surveillance and pharmacovigilance coordination.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, or a related field; advanced degree preferred.
• Minimum of 6 years of experience in regulatory affairs within the pharmaceutical industry.
• Proven experience in preparing and submitting regulatory applications in key markets.
• In-depth knowledge of regulatory guidelines and requirements (e.g., ICH, SAHPRA).
• Excellent written and verbal communication skills, strong analytical abilities, and strategic thinking for complex regulatory challenges in Stellenbosch .

Benefits

• Competitive annual salary and performance incentives.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan with employer contribution.
• Opportunities for continuous professional development and international regulatory training.
• Hybrid work model promoting flexibility and collaboration within the regulatory affairs function.