Senior Pharmaceutical Regulatory Affairs Specialist

Placements24; Queenstown; Hybrid; NZD 65,000 - 98,000; Full time

Benefits offered by this job

Medical aid

Retirement savings

Performance-based bonuses

Job summary

Our client in Queenstown, South Africa, seeks a Senior Pharmaceutical Regulatory Affairs Specialist to lead regulatory submissions and ensure compliance across SAHPRA and selected international markets. The role is hybrid, balancing on-site collaboration with flexible remote work.

The ideal candidate will drive regulatory strategies and lifecycle management of pharmaceutical products. With 5+ years in regulatory affairs, you will navigate CTD formats, provide strategic guidance to

Qualifications

• Minimum of 5 years experience in pharmaceutical regulatory affairs.
• In-depth knowledge of SAHPRA requirements; FDA/EMA experience is advantageous.
• Experience preparing/submitting dossiers for new marketing authorizations and variations.
• Strong understanding of development, manufacturing, and quality control principles.
• Excellent analytical, problem-solving, and strategic thinking skills.
• Exceptional written and verbal communication skills.
• Detail-oriented with strong organizational and project management abilities.
• Ability to work independently and collaboratively in fast-paced environments.
• Familiarity with CTD (Common Technical Document) format is highly desirable.

Responsibilities

• Prepare, review, and submit regulatory documentation for NDAs, variations, and renewals to SAHPRA and other international bodies.
• Ensure compliance with pharmaceutical regulations, guidelines, and company policies.
• Provide regulatory strategic advice to project teams, R&D, and commercial departments.
• Evaluate changes to products, processes, and labeling for regulatory impact and manage submissions.
• Respond to queries from regulatory authorities and manage post-approval commitments.
• Maintain regulatory databases and filing systems with accurate records.
• Monitor regulatory intelligence and identify legislative changes impacting the company.
• Collaborate with quality, manufacturing, and marketing to align regulatory strategies.
• Support regulatory inspections and audits.
• Contribute to regulatory strategies for new product development and lifecycle management.

Skills

Regulatory strategy

CTD familiarity

Documentation management

Regulatory intelligence

Stakeholder communication

Education

Bachelor's or Master's in Pharmacy, Chemistry, Life Sciences

Job description

About the Role

Our client, a globally recognized pharmaceutical company, is seeking an experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their team in Queenstown, Eastern Cape. This critical role involves managing regulatory submissions, ensuring compliance with local and international regulations, and supporting the lifecycle management of pharmaceutical products. The ideal candidate will possess a deep understanding of regulatory pathways, documentation requirements, and the evolving landscape of pharmaceutical legislation. This is an excellent opportunity to leverage your expertise in regulatory affairs to make a significant impact on product approvals and market access within a dynamic and supportive work environment. The hybrid model offers flexibility while ensuring essential on-site collaboration.

Key Responsibilities

• Prepare, review, and submit regulatory documentation for new drug applications (NDAs), variations, and renewals to health authorities, primarily SAHPRA and potentially other international bodies.
• Ensure compliance with all relevant pharmaceutical regulations, guidelines, and company policies.
• Provide regulatory strategic advice to project teams, R&D, and commercial departments.
• Evaluate changes to products, processes, and labeling for regulatory impact and manage associated submissions.
• Respond to queries from regulatory authorities and manage post-approval commitments.
• Maintain regulatory databases and filing systems, ensuring accurate and up-to-date records.
• Monitor regulatory intelligence, identifying changes in legislation and guidance that may impact the company's products or operations.
• Collaborate with cross-functional teams, including quality, manufacturing, and marketing, to ensure alignment on regulatory strategies.
• Support regulatory inspections and audits.
• Contribute to the development of regulatory strategies for new product development and lifecycle management.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related discipline.
• Minimum of 5 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of regulatory requirements and submission processes in South Africa (SAHPRA) is essential; experience with other major markets (e.g., FDA, EMA) is advantageous.
• Proven experience in preparing and submitting dossiers for new marketing authorizations and variations.
• Strong understanding of pharmaceutical development, manufacturing, and quality control principles.
• Excellent analytical, problem-solving, and strategic thinking skills.
• Exceptional written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
• Detail-oriented with strong organizational and project management abilities.
• Ability to work independently and collaboratively in a fast-paced environment.
• Familiarity with CTD (Common Technical Document) format is highly desirable.

Benefits

Our client offers a competitive salary package, commensurate with experience, and a comprehensive benefits program including medical aid, retirement savings, and performance-based bonuses. Opportunities for continuous professional development and global exposure within regulatory affairs are readily available. This hybrid role provides the flexibility to balance remote work with essential on-site responsibilities in Queenstown, contributing to critical pharmaceutical advancements.