Senior Regulatory Affairs Specialist

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

Benefits offered by this job

Medical aid

Retirement fund

Life insurance

International travel

Career growth

Job summary

Placements24 seeks a Senior Regulatory Affairs Specialist in Rustenburg to drive regulatory strategy and lifecycle management for pharmaceutical products. You will prepare and submit dossiers, interact with SAHPRA, and guide cross-functional teams on compliance throughout product life cycles.

The role requires strong communication and negotiation skills, detailed regulatory knowledge, and a track record of successful registrations. Travel for conferences and regulatory meetings is possible.

Qualifications

• Bachelor's degree in Pharmacy, Law, Life Sciences or related field.

Responsibilities

• Develop and implement regulatory strategies for product registration and lifecycle management in SA and key regions.
• Prepare, review and submit regulatory documentation to health authorities such as SAHPRA.
• Act as primary contact with regulatory agencies and manage interactions.
• Provide regulatory guidance to R&D, marketing and manufacturing teams.

Skills

Regulatory strategy

Dossier submission

SAHPRA regulations

Regulatory submissions

Stakeholder negotiation

Attention to detail

Analytical skills

Education

Bachelor's degree in Pharmacy/Life Sciences/Law

Job description

About the Role

Our client is seeking a strategic and experienced Senior Regulatory Affairs Specialist to join their regulatory team based in Rustenburg . This pivotal role involves ensuring that all pharmaceutical products comply with local and international regulatory standards throughout their lifecycle. You will be at the forefront of navigating complex regulatory landscapes, contributing to product approvals and lifecycle management. This position offers a significant opportunity to impact product strategy and market access, working within a company that values compliance, innovation, and global health. You will collaborate closely with cross-functional teams to achieve regulatory success.

Key Responsibilities

• Develop and implement regulatory strategies for product registration and lifecycle management in assigned markets, focusing on South Africa and other key regions.
• Prepare, review, and submit regulatory documentation (e.g., dossiers , variations, renewals) to health authorities such as the SAHPRA.
• Act as a primary point of contact with regulatory agencies, responding to queries and managing interactions effectively.
• Provide regulatory guidance and support to internal teams, including R&D, marketing, and manufacturing, on compliance matters.
• Monitor changes in the regulatory environment and assess their impact on the company's products and operations.
• Ensure that product labeling, advertising, and promotional materials comply with all applicable regulations and guidelines.

Requirements

• Bachelor's degree in Pharmacy, Law, Life Sciences, or a related field.
• A Master's degree or professional certification is a plus.
• Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs, with a strong understanding of SAHPRA regulations.
• Proven track record of successful product registrations and post-approval submissions.
• Excellent understanding of the pharmaceutical product lifecycle and related regulatory requirements.
• Strong communication, negotiation, and interpersonal skills, with the ability to influence stakeholders.
• Meticulous attention to detail and strong analytical and problem-solving capabilities.

Benefits

• An attractive annual salary commensurate with experience and qualifications.
• Comprehensive medical aid, retirement fund, and life insurance benefits.
• Opportunities for international travel to attend conferences and regulatory meetings.
• Significant potential for career growth into leadership roles within regulatory affairs.
• A collaborative and ethical work environment that promotes professional development and work-life balance.