Regulatory Affairs Specialist - Pharmaceutical Submissions

Placements24; Paarl; Sur place; ZAR 700 000 - 1 000 000; Plein temps

Avantages offerts par ce poste

Medical aid

Life assurance

Provident fund

Annual leave

Résumé du poste

Placements24 seeks a Regulatory Affairs Specialist for its Paarl-based team. You will prepare, submit and maintain regulatory dossiers (CTD/eCTD) for new and existing medicines, ensuring SAHPRA, FDA and EMA compliance throughout the product lifecycle.

You will collaborate with R&D, Manufacturing and Quality Assurance, monitor regulatory changes, respond to agency queries, and guide cross-functional teams on regulatory strategies in the South Africa and international markets.

Qualifications

• Bachelor's degree in pharmacy, chemistry, biology or life sciences.
• 4–6 years in pharmaceutical regulatory affairs.
• Strong knowledge of CTD/eCTD and SAHPRA submission.
• Proficient in ICH, FDA, EMA guidelines.
• Excellent written and verbal communication.
• Ability to manage multiple dossiers and deadlines.

Responsabilités

• Prepare and compile regulatory submission dossiers (CTD, eCTD) for NDAs, variations and renewals.
• Ensure submissions meet requirements of SAHPRA, FDA and EMA.
• Liaise with R&D, Manufacturing and QA to gather information for submissions.
• Monitor regulatory changes and assess impact on products and strategies.
• Maintain regulatory documentation and databases with accuracy.
• Respond to health authority queries during reviews.
• Manage post-approval regulatory commitments and ongoing compliance.
• Review promotional materials and labeling for regulatory compliance.
• Provide regulatory guidance to cross-functional teams.
• Contribute to development and implementation of regulatory strategies.

Connaissances

Regulatory affairs

Documentation drafting

Attention to detail

Communication skills

Formation

Bachelors in Pharmacy/ Chemistry/ Biology

Outils

RIMS

CTD/eCTD

Description du poste

About the Role

Our client, a respected global leader in the pharmaceutical industry, is seeking a diligent and knowledgeable Regulatory Affairs Specialist . This crucial role, based in Paarl, Western Cape , will focus on the preparation, submission, and maintenance of regulatory documentation for new and existing pharmaceutical products. The Specialist will ensure compliance with national and international regulatory requirements, facilitating the smooth market entry and lifecycle management of our client's innovative medicines. This position is ideal for a detail-oriented professional with a strong understanding of the regulatory landscape. Join our committed team in Paarl and play a vital role in bringing essential therapies to patients worldwide. The position is office-based, requiring your presence to collaborate closely with internal and external stakeholders.

Key Responsibilities

• Prepare and compile high-quality regulatory submission dossiers (e.g., CTD, eCTD) for new drug applications (NDAs), variations, and renewals.


• Ensure all regulatory submissions meet the requirements of relevant health authorities (e.g., SAHPRA, FDA, EMA).


• Liaise with internal departments (R&D, Manufacturing, Quality Assurance) and external partners to gather necessary information for submissions.


• Monitor changes in the regulatory landscape and assess their impact on company products and strategies.


• Maintain regulatory documentation and databases, ensuring accuracy and completeness.


• Respond to queries from health authorities during the review process.


• Manage post-approval regulatory commitments and ensure ongoing compliance.


• Review promotional materials and labelling for regulatory compliance.


• Provide regulatory guidance and support to cross-functional teams.


• Contribute to the development and implementation of regulatory strategies.

Requirements

• A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline; advanced degrees are advantageous.


• A minimum of 4-6 years of experience in pharmaceutical regulatory affairs.


• Thorough understanding of regulatory submission processes and requirements in key markets, including South Africa.


• Experience with Common Technical Document (CTD) format and electronic submission platforms.


• Proficiency in regulatory guidelines (ICH, FDA, EMA, SAHPRA).


• Excellent written and verbal communication skills, with a strong ability to draft clear and concise regulatory documents.


• Strong analytical and problem-solving skills, with meticulous attention to detail.


• Ability to manage multiple projects, prioritize tasks, and meet tight deadlines.


• Proficiency in MS Office Suite and regulatory information management systems (RIMS).

Benefits

• Our client provides a competitive salary package and a comprehensive range of benefits, including medical aid, life assurance, and a provident fund.


• Opportunities for continuous learning and professional development, including participation in industry conferences and training programs, are readily available.


• The role is based in our modern facility in Paarl, Western Cape, fostering a professional and collaborative work environment.


• We offer a generous annual leave policy and prioritize employee well-being and career progression within the organisation.