Senior Regulatory Affairs Manager

Placements24; Pretoria; On-site; ZAR 1,000,000 - 1,600,000; Full time

Benefits offered by this job

Competitive salary

Medical aid

Retirement fund contributions

Life insurance

On-site facilities

Job summary

Placements24 is seeking a Senior Regulatory Affairs Manager to lead regulatory strategies for product registrations and lifecycle management in the South African market from our Pretoria facility.

You will guide a team, align with SAHPRA requirements and international guidelines, and partner with R&D, manufacturing, and commercial functions to ensure timely approvals and compliant marketing materials.

Qualifications

• SAHPRA knowledge and international guidelines (ICH) familiarity.
• 7+ years in regulatory affairs within pharma, with leadership experience.
• Experience preparing/submitting MAAs or equivalent.
• Strong project management and organizational skills.
• Excellent written and verbal communication with health authorities.

Responsibilities

• Develop and execute regulatory strategies for new registrations and lifecycle management.
• Prepare and submit regulatory dossiers (CTD format) to SAHPRA and other regions.
• Serve as primary point of contact for regulatory agencies and inquiries.
• Interpret regulatory requirements and advise cross-functional teams.
• Oversee review of marketing materials for compliance.
• Mentor junior regulatory staff and ensure SOP adherence.
• Monitor regulatory landscape and assess impact on business.
• Manage variations, renewals, and annual reports post-approval.

Skills

Regulatory strategy

Project management

Regulatory liaison

Team leadership

Communication with health authorities

Strategic planning

Regulatory intelligence

Education

Bachelor's or Master's in Pharmacy

Life Sciences or Chemistry

Tools

Regulatory information management systems

Job description

About the Role

Our client, a prominent pharmaceutical company, is seeking an experienced Senior Regulatory Affairs Manager to join their team in Pretoria, Gauteng, ZA . This is a critical in-office role where you will lead and execute regulatory strategies for product registration and lifecycle management within the South African market and potentially beyond. You will be responsible for ensuring compliance with all local and international regulatory requirements, acting as the key liaison between the company and health authorities. This position requires a deep understanding of the pharmaceutical regulatory landscape, exceptional strategic planning skills, and the ability to navigate complex regulatory pathways. As a Senior Manager, you will guide a team of regulatory professionals, contributing significantly to the company's success by bringing innovative medicines to patients efficiently and safely. We are looking for a proactive, detail-oriented leader who thrives in a collaborative office environment and is passionate about regulatory excellence in the pharmaceutical sector. Your expertise will be vital in shaping regulatory submissions and ensuring timely approvals.

Key Responsibilities

• Develop and implement comprehensive regulatory affairs strategies for new product registrations and lifecycle management.


• Prepare, review, and submit regulatory dossiers (e.g., CTD format) to health authorities in Pretoria and other relevant regions.


• Act as the primary point of contact for regulatory agencies, managing communications and responses to inquiries.


• Interpret and advise on regulatory requirements, guidelines, and policies affecting the company's products.


• Oversee the regulatory review process for marketing materials, labeling, and promotional activities to ensure compliance.


• Collaborate closely with R&D, clinical, manufacturing, and commercial teams to ensure regulatory alignment throughout the product lifecycle.


• Manage regulatory post-approval activities, including variations, renewals, and annual reports.


• Monitor changes in the regulatory landscape and assess their impact on the company's business.


• Provide guidance and mentorship to junior regulatory affairs staff.


• Ensure adherence to all company SOPs and relevant regulatory standards.

Requirements

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline.


• Minimum of 7 years of experience in regulatory affairs within the pharmaceutical industry, with at least 2 years in a management or lead role.


• In-depth knowledge of South African regulatory requirements (SAHPRA) and international guidelines (e.g., ICH).


• Proven experience in preparing and submitting Marketing Authorization Applications (MAAs) or equivalent.


• Strong understanding of drug development processes and pharmaceutical manufacturing.


• Excellent project management, organizational, and negotiation skills.


• Exceptional written and verbal communication skills, with a track record of effective communication with health authorities.


• Ability to work effectively in a team environment and manage multiple projects simultaneously.


• Proficiency in regulatory information management systems is a plus.


• Strategic thinking and problem-solving capabilities.

Benefits

• Our client offers a competitive salary, attractive bonus structure, and comprehensive benefits package including medical aid, retirement fund contributions, and life insurance.


• This role is based in our state-of-the-art facility in Pretoria, Gauteng, ZA .


• We provide opportunities for continuous professional development, including attendance at industry conferences and specialized training.


• Generous annual leave, sick leave, and family responsibility leave are provided.


• The company culture fosters collaboration, innovation, and professional growth.


• On-site amenities and easy access to public transport make this a convenient and rewarding workplace.


• You will be working alongside a team of dedicated professionals committed to bringing essential medicines to market.