Senior Regulatory Affairs Specialist - Dossier Submission

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

Benefits offered by this job

Private medical insurance

Retirement fund

Annual bonuses

Hybrid work arrangement

Job summary

Placements24 is seeking an experienced Senior Regulatory Affairs Specialist in Benoni, Gauteng, to lead dossier submissions for international markets. The role requires deep knowledge of CTD/eCTD, SAHPRA, FDA and EMA guidelines, and collaboration with R&D, QA, manufacturing and marketing teams.

You will manage submission plans, ensure labeling and product information compliance, and monitor regulatory changes to keep the portfolio on track for timely registrations and lifecycle management.

Qualifications

• Minimum 5 years of progressive experience in pharmaceutical regulatory affairs.
• Proven experience with dossier preparation and submission (CTD/eCTD).
• Experience interacting with regulators (SAHPRA, FDA, EMA).
• Knowledge of CMC requirements and labeling/packaging compliance.

Responsibilities

• Prepare, review and manage regulatory dossiers for new drugs, variations and renewals.
• Apply ICH, FDA, EMA and SAHPRA guidelines to submission strategies.
• Liaise with national and regional health authorities to address queries.
• Develop submission plans and timelines aligned with development strategy.

Skills

Attention to detail

Regulatory intelligence

Strong communication

Project management

Education

Bachelor's degree in Pharmacy, Chemistry, Biology

Master's or PhD (advantage)

Tools

Regulatory information management systems

Job description

About the Role

Our client, a well-established pharmaceutical company with a growing portfolio, is seeking an experienced Senior Regulatory Affairs Specialist to lead their dossier submission efforts. This role is crucial for ensuring timely and compliant registration of pharmaceutical products in various international markets. Based in Benoni, Gauteng , you will be responsible for preparing, reviewing, and submitting high-quality regulatory dossiers, liaising with health authorities, and staying abreast of evolving regulatory landscapes. The ideal candidate possesses a strong understanding of global regulatory requirements, excellent attention to detail, and exceptional communication skills. This is a strategic position offering significant impact and career growth within a reputable organization committed to improving global health. Join a team that is dedicated to navigating the complexities of pharmaceutical regulation.

Key Responsibilities

• Prepare, review, and manage the submission of regulatory dossiers (e.g., CTD/eCTD) for new drug applications (NDAs), variations, and renewals.
• Interpret and apply global regulatory guidelines (e.g., ICH, FDA, EMA, SAHPRA) to product registration strategies.
• Liaise directly with national and regional health authorities to facilitate dossier reviews and address queries.
• Develop and maintain regulatory submission plans and timelines in alignment with product development strategies.
• Ensure compliance of labeling, packaging, and product information with regulatory requirements.
• Conduct regulatory intelligence activities to monitor changes in the regulatory environment and assess impact on company products.
• Collaborate closely with R&D, Quality Assurance, Manufacturing, and Marketing departments to gather necessary information for submissions.
• Provide regulatory input and support throughout the product lifecycle.
• Maintain regulatory databases and ensure accurate record-keeping.
• Contribute to the development and implementation of departmental SOPs and best practices.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field; Advanced degree (Master's or PhD) is a plus.
• Minimum of 5 years of progressive experience in pharmaceutical regulatory affairs, with a strong focus on dossier preparation and submission.
• In-depth knowledge of the Common Technical Document (CTD/eCTD) format and requirements.
• Proven experience interacting with regulatory agencies such as SAHPRA, FDA, and EMA.
• Familiarity with CMC (Chemistry, Manufacturing, and Controls) requirements.
• Excellent written and verbal communication skills, with strong attention to detail.
• Proficiency in regulatory information management systems and standard office software.
• Strong analytical and problem-solving abilities.
• Ability to manage multiple projects simultaneously and meet tight deadlines.

Benefits

Our client offers a competitive salary and a comprehensive benefits package, including private medical insurance, a retirement fund, and potential for annual bonuses. Professional development is highly valued, with opportunities for advanced training, conference attendance, and staying current with regulatory changes. Paid annual leave, sick leave, and other statutory benefits are provided. This hybrid role in Benoni, Gauteng , provides a dynamic work environment with the flexibility to balance office-based collaboration with remote work for focused dossier preparation and review. Join a company that offers a clear career path and the chance to significantly contribute to bringing vital medicines to patients worldwide.