Senior Regulatory Affairs Specialist

Placements24; Mossel Bay; Hybrid; ZAR 700,000 - 1,000,000; Full time

Benefits offered by this job

Medical aid

Retirement provisions

Paid leave

Job summary

Placements24 is seeking an experienced Senior Regulatory Affairs Specialist for Mossel Bay in a hybrid role that balances on-site engagement with remote work. The role focuses on regulatory strategy, submissions, and ensuring compliance with national and international regulations.

You will liaise with SAHPRA, FDA, and EMA, guide cross-functional teams, and monitor regulatory changes to inform product strategy and lifecycle management.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences or Chemistry.
• 5+ years in regulatory affairs within the pharmaceutical industry.
• Experience with SAHPRA and international regulators.

Responsibilities

• Prepare, review and submit regulatory dossiers (CTD format) for new drug applications and variations.
• Liaise with regulatory authorities such as SAHPRA, FDA and EMA.
• Provide regulatory guidance to cross-functional teams (R&D, manufacturing, marketing).
• Monitor regulatory changes and assess impact on products and strategies.
• Manage post-approval regulatory activities (amendments, annual reports).
• Review promotional materials and labeling for compliance.
• Develop and implement regulatory strategies for product registration and lifecycle management.
• Conduct regulatory intelligence activities and competitor analysis.
• Contribute to development and implementation of departmental SOPs.

Skills

Communication

Analytical thinking

Problem solving

Regulatory knowledge

Team collaboration

Education

Bachelor's degree in Pharmacy or related field

Master's degree advantageous

Tools

Regulatory information management systems

Job description

About the Role

Our client, a reputable pharmaceutical organization, is seeking an experienced Senior Regulatory Affairs Specialist to join their team in Mossel Bay. This hybrid role balances essential on-site engagement with the flexibility of remote work, offering a unique opportunity to contribute to regulatory strategy and submissions. The Specialist will be responsible for ensuring that our client's pharmaceutical products comply with all relevant national and international regulations. You will play a key role in preparing and submitting regulatory documentation, liaising with health authorities, and providing regulatory guidance to internal teams. This position is crucial for facilitating the timely approval and market access of innovative therapies. The ideal candidate will possess a deep understanding of the pharmaceutical regulatory landscape and a commitment to upholding the highest standards of compliance.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD format) for new drug applications and variations.
• Liaise effectively with regulatory authorities such as SAHPRA, FDA, and EMA.
• Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing.
• Monitor changes in the regulatory landscape and assess their impact on the company's products and strategies.
• Manage post-approval regulatory activities, including amendments and annual reports.
• Review promotional materials and labeling for regulatory compliance.
• Develop and implement regulatory strategies for product registration and lifecycle management.
• Conduct regulatory intelligence activities and competitor analysis.
• Contribute to the development and implementation of departmental SOPs.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• A Master's degree or relevant professional qualification is advantageous.
• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry.
• In-depth knowledge of pharmaceutical regulations and guidelines in key markets (South Africa essential).
• Proven experience in preparing and submitting regulatory dossiers.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work independently and collaboratively in a hybrid work environment.
• Strong analytical and problem-solving skills.
• Proficiency in regulatory information management systems is a plus.

Benefits

Our client offers a competitive annual salary and a comprehensive benefits package, including medical aid, retirement provisions, and paid leave. The hybrid work model provides a flexible approach to managing work and personal life. Our client is dedicated to fostering employee growth through continuous training, professional development opportunities, and support for further education. Employees benefit from a supportive team environment and the chance to work on impactful projects that contribute to global health advancements. The Mossel Bay location offers a unique coastal lifestyle.