Senior Pharmaceutical Regulatory Affairs Specialist

Placements24; Benoni; Vor Ort; ZAR 900.000 - 1.500.000; Vollzeit

Benefits dieser Stelle

Health benefits

Career advancement

Team environment

Learning opportunities

Zusammenfassung

Placements24 is seeking a Senior Pharmaceutical Regulatory Affairs Specialist to lead regulatory submissions and strategy from Benoni, Gauteng. You will coordinate with health authorities worldwide and guide product lifecycle decisions to ensure market access and compliance.

The role requires extensive experience in regulatory affairs, CTD dossier preparation, and strong cross-functional collaboration to support development and post-approval activities.

Qualifikationen

• 6+ years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of SAHPRA and global submission requirements.
• Experience preparing and managing CTD dossiers.
• Strong understanding of product development, manufacturing and QA.
• Excellent communication and negotiation skills.
• Proficiency with regulatory information management systems desirable.
• Detail-oriented with strong organizational skills.

Aufgaben

• Prepare, compile, and submit regulatory dossiers for NDAs, variations, and renewals (SAHPRA, FDA, EMA).
• Act as primary contact with regulatory health authorities and manage inquiries.
• Interpret and advise on national and international regulatory requirements and guidelines.
• Review labeling, promotional materials, and product information for compliance.
• Develop regulatory strategies for development and lifecycle management.
• Conduct regulatory intelligence to stay ahead of changes.
• Oversee post-approval activities (annual reports, safety updates).
• Collaborate with R&D, Clinical, Quality, Manufacturing, Marketing to meet lifecycle requirements.
• Participate in regulatory inspections and provide support as needed.
• Maintain regulatory documentation and databases.

Kenntnisse

Regulatory strategy

Regulatory intelligence

Stakeholder communication

Prioritization

Analytical thinking

Ausbildung

Bachelor's or Master's degree in Pharmacy or Life Sciences

Tools

Regulatory information management systems

Jobbeschreibung

About the Role

Our client, a respected pharmaceutical entity, is seeking a highly knowledgeable and experienced Senior Pharmaceutical Regulatory Affairs Specialist to enhance their regulatory compliance team in Benoni, Gauteng . This critical role involves navigating the complex landscape of pharmaceutical regulations to ensure our client's products achieve and maintain market authorization globally. You will be responsible for preparing, reviewing, and submitting regulatory dossiers, liaising with health authorities, and providing strategic guidance on regulatory requirements. This position offers a significant opportunity to influence product lifecycle management and contribute to bringing innovative therapies to patients. We are looking for a meticulous, strategic thinker with a proven track record in pharmaceutical regulatory affairs. Your expertise will be crucial in ensuring our client's continued success and adherence to international standards. This role is pivotal for maintaining market access and compliance.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers for new drug applications (NDAs), variations, and renewals in various markets (e.g., SAHPRA, FDA, EMA).
• Serve as the primary point of contact with regulatory health authorities, managing all correspondence and inquiries.
• Interpret and advise on national and international regulatory requirements, guidelines, and trends affecting pharmaceutical products.
• Review and approve labeling, promotional materials, and product information to ensure regulatory compliance.
• Develop regulatory strategies for product development and lifecycle management.
• Conduct regulatory intelligence activities to stay informed about changes in the regulatory landscape.
• Oversee post-approval regulatory activities, including annual reports and safety updates.
• Collaborate with internal teams (R&D, Clinical, Quality, Manufacturing, Marketing) to ensure regulatory requirements are met throughout the product lifecycle.
• Participate in regulatory inspections and provide necessary support.
• Maintain regulatory documentation and databases.
• Provide regulatory input for product development, clinical trial applications, and manufacturing change controls.

Requirements

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline.
• A minimum of 6 years of comprehensive experience in pharmaceutical regulatory affairs.
• In-depth knowledge of regulatory submission processes and requirements in key markets, including South Africa (SAHPRA).
• Proven experience in preparing and managing regulatory dossiers (e.g., CTD format).
• Strong understanding of pharmaceutical product development, manufacturing, and quality assurance principles.
• Excellent communication, negotiation, and interpersonal skills.
• Ability to analyze complex regulatory information and provide clear strategic guidance.
• Proficiency in regulatory information management systems is desirable.
• Detail-oriented with exceptional organizational skills.
• Ability to work independently and manage multiple priorities effectively.
• Fluency in English; knowledge of other languages relevant to global markets is a plus.

Benefits

• Our client offers a competitive compensation package, comprehensive health benefits, and excellent opportunities for career advancement within a reputable organization.
• This role, situated in Benoni, Gauteng , offers a chance to work on diverse projects and contribute significantly to regulatory strategy.
• Employees benefit from a supportive team environment, continuous learning opportunities, and the chance to be part of a company dedicated to improving health outcomes.
• We are committed to attracting and retaining top talent by offering a stimulating and rewarding work experience.