Regulatory Affairs Specialist - Pharmaceutical

Placements24; Mossel Bay; Hybrid; ZAR 700,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Medical aid

Disability cover

Retirement fund

Professional development

Bonuses

Annual leave

Job summary

Placements24 in Mossel Bay, Western Cape, seeks an experienced Regulatory Affairs Specialist to ensure SAHPRA compliance and international regulatory alignment. Hybrid role blending on-site strategy and remote execution.

You will prepare dossiers, review labeling, and guide cross-functional teams across R&D, marketing and manufacturing, navigating evolving regulations with meticulous documentation. The role offers professional development opportunities and a collaborative, dynamic environment

Qualifications

• Bachelor's degree in a related field; Master's degree advantageous.
• Minimum 4–6 years in pharmaceutical regulatory affairs with SAHPRA focus.
• Experience with CTD format and dossier preparation.
• Strong writing and communication skills; attention to detail.
• Ability to manage multiple projects and meet deadlines.
• Hybrid work setup with strong collaboration.

Responsibilities

• Prepare regulatory dossiers for NDAs, variations, and renewals to SAHPRA and others.
• Review labeling and promotional materials for compliance.
• Provide regulatory guidance to R&D, marketing and manufacturing.
• Monitor regulatory changes and impact on products.
• Maintain regulatory databases and track submission statuses.
• Respond to health authority queries and manage post-approval commitments.
• Conduct regulatory intelligence to identify trends.
• Liaise with external consultants and partners.
• Ensure GRP compliance and internal SOP adherence.

Skills

Regulatory affairs

SAHPRA submissions

CTD dossier preparation

Regulatory intelligence

Regulatory writing

Cross-functional collaboration

Regulatory information management

Education

Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or Law

Master's degree or professional certification

Tools

Regulatory information management systems

Document management systems

Job description

About the Role

Our client, a dynamic and growing pharmaceutical company, is seeking an experienced Regulatory Affairs Specialist to join their team in Mossel Bay, Western Cape, ZA. This role is crucial for ensuring that our client's pharmaceutical products meet all national and international regulatory requirements, facilitating timely product approvals and maintaining compliance throughout the product lifecycle. The ideal candidate will possess a strong understanding of pharmaceutical regulations and a meticulous approach to documentation and submission preparation. This position adopts a hybrid work model, allowing for a blend of on-site strategic planning and remote execution of tasks. You will be integral in navigating the complex regulatory landscape to bring innovative medicines to patients.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers for new drug applications (NDAs), variations, and renewals to health authorities, primarily SAHPRA and potentially others.
• Review and assess labeling, promotional materials, and advertising content for regulatory compliance.
• Provide regulatory guidance and support to cross-functional teams, including R&D, marketing, and manufacturing.
• Monitor changes in the regulatory environment and assess their impact on the company's products and strategies.
• Maintain regulatory databases and ensure the accurate tracking of submission status and approvals.
• Respond to queries from health authorities and manage post-approval regulatory commitments.
• Conduct regulatory intelligence activities to identify emerging trends and opportunities.
• Liaise with external regulatory consultants and partners as needed.
• Ensure compliance with Good Regulatory Practices (GRP) and internal SOPs.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, Law, or a related field.
• A Master's degree or relevant professional certification is advantageous.
• Minimum of 4-6 years of experience in pharmaceutical regulatory affairs, with a strong focus on SAHPRA submissions.
• Thorough knowledge of pharmaceutical regulatory requirements, guidelines, and submission processes in South Africa and ideally other key markets.
• Experience with dossier preparation using Common Technical Document (CTD) format.
• Excellent analytical, writing, and communication skills.
• Ability to manage multiple projects simultaneously and meet strict deadlines.
• Proficiency in regulatory information management systems and databases.
• Strong attention to detail and organizational skills.
• Ability to work effectively in a hybrid setup, demonstrating self-discipline and collaboration.
• Experience with medical devices or complementary medicines is a plus.

Benefits

• Our client offers a competitive salary, comprehensive health benefits including medical aid and disability cover, and a retirement fund.
• Employees benefit from opportunities for professional development, including attendance at industry conferences and training programs.
• This hybrid role, situated in Mossel Bay, Western Cape, ZA, provides a flexible work environment combined with the satisfaction of contributing to regulatory success in the pharmaceutical industry.
• Additional benefits include performance bonuses and generous annual leave.