Senior Regulatory Affairs Manager - Pharmaceutical

Placements24; Stellenbosch; Hybrid; ZAR 1,800,000 - 2,800,000; Full time

Benefits offered by this job

Executive salary and bonus

Comprehensive health and lifeinsurance

Retirement benefits

Generous annual leave

Professional development opportunities

Hybrid work arrangement

Job summary

Placements24, on behalf of a leading pharmaceutical company, seeks a Senior Regulatory Affairs Manager to lead regulatory strategy and submissions for SA markets from Stellenbosch, Western Cape. The role blends home-office work with essential on-site collaboration.

You will manage SAHPRA dossiers, ensure GMP/GCP/GLP compliance, mentor a regulatory team and coordinate with R&D, manufacturing and marketing to support product registrations and lifecycle management.

Qualifications

• Advanced degree (Master's or PhD) in Pharmacy, Chemistry, Biology or related field.
• Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
• In-depth knowledge of SAHPRA regulations and submission requirements, as well as international regulatory frameworks (e.g., FDA, EMA).
• Proven track record of successful regulatory submissions and approvals.
• Excellent strategic thinking, analytical, and problem-solving skills.
• Strong leadership and team management capabilities.
• Exceptional written and verbal communication skills, with a high degree of accuracy.
• Ability to work independently and manage multiple projects simultaneously.

Responsibilities

• Develop regulatory strategies for new product registrations and lifecycle management.
• Prepare, review, and submit regulatory dossiers to health authorities in South Africa and other target markets.
• Ensure ongoing compliance with GMP, GCP, GLP.
• Act as the primary point of contact with regulatory agencies, responding to queries.
• Monitor changes in the regulatory landscape and assess their impact on products and operations.
• Provide regulatory guidance and support to R&D, manufacturing, marketing, and other departments.
• Manage regulatory aspects of product recalls, variations, and annual reports.
• Lead and mentor a team of regulatory affairs professionals.

Skills

Regulatory strategy

Team leadership

Regulatory submissions

SAHPRA knowledge

Regulatory information management

Education

Master's or PhD in Pharmacy, Chemistry, Biology

Tools

Regulatory information management systems

FDA/EMA frameworks

Job description

About the Role

Our client, a distinguished pharmaceutical company, is seeking an experienced Senior Regulatory Affairs Manager to lead regulatory strategy and operations for their product portfolio, based in the scenic region of Stellenbosch, Western Cape. This role is instrumental in ensuring compliance with all relevant pharmaceutical regulations, facilitating timely product approvals, and maintaining market authorizations. The Senior Regulatory Affairs Manager will provide expert guidance on regulatory requirements, manage submissions, and liaise with health authorities, including SAHPRA. This hybrid position allows for focused work from a home office combined with essential on-site collaboration and meetings in Stellenbosch, offering flexibility for professionals in the wine region.

Key Responsibilities

• Develop and implement comprehensive regulatory strategies for new product registrations and lifecycle management.
• Prepare, review, and submit regulatory dossiers to health authorities in South Africa and other target markets.
• Ensure ongoing compliance with all applicable regulations, guidelines, and standards (e.g., GMP, GCP, GLP).
• Act as the primary point of contact with regulatory agencies, responding to queries and managing communications.
• Monitor changes in the regulatory landscape and assess their impact on the company's products and operations.
• Provide regulatory guidance and support to R&D, manufacturing, marketing, and other relevant departments.
• Manage regulatory aspects of product recalls, variations, and annual reports.
• Lead and mentor a team of regulatory affairs professionals.

Requirements

• Advanced degree (Master's or PhD) in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
• In-depth knowledge of SAHPRA regulations and submission requirements, as well as international regulatory frameworks (e.g., FDA, EMA).
• Proven track record of successful regulatory submissions and approvals.
• Excellent strategic thinking, analytical, and problem-solving skills.
• Strong leadership and team management capabilities.
• Exceptional written and verbal communication skills, with a high degree of accuracy.
• Ability to work independently and manage multiple projects simultaneously.
• Proficiency in regulatory information management systems.
• Willingness to travel as required for meetings and conferences.

Benefits

• Highly competitive executive salary and bonus structure.
• Comprehensive healthcare, life insurance, and retirement benefits.
• Generous annual leave and flexible working arrangements.
• Significant opportunities for professional development and leadership growth.
• Work with a globally recognized leader in the pharmaceutical industry.
• Beautiful work environment in the heart of the Cape Winelands.