Senior Regulatory Affairs Specialist/ Responsible Pharmacist

Senior Regulatory Affairs Specialist/ Responsible Pharmacist
Isando, SA
Hybrid

dsm-firmenich is seeking an experienced Regulatory Affairs Specialist/ Responsible Pharmacist with expertise in the South African regulatory landscape in Food and Pharmaceuticals.

This role will be a key contact with local authorities and trade associations, guiding the business through local regulations.

Your Key Responsibilities:

• Contribute as a Regulatory Affairs (RA) team member in the development of the global product approval strategy in a timely and accurate manner.
• Act as Responsible Pharmacist and be the contact for communication towards South African Health Products Regulatory Authority (SAHPRA), South African Pharmacy Council (SAPC), and the National Department of Health.
• Prepare registration dossiers, necessary certificates, and documentation for product submission and approvals towards different authorities in Sub Sahara Africa (SSA) including SAHPRA, Nigerian National Agency for Food and Drug Administration and Control (NAFDAC), and Pharmacy and Poisons Board of Kenya.
• Support customer queries related to food, health supplements, and pharma, in close collaboration with other internal functions.
• Ensure that internal documents such as advertising, marketing materials, and product labels are in line with applicable regulations.
• Contribute to the monitoring, representation, and shaping activities in SSA region trade associations and other industry-related conferences/organizations.
• Write and update Standard Operating Procedures (SOPs) related to the job function to ensure compliance with medicines practices in the SSA region.

We bring:

• An open, trusted, and flexible work environment that empowers people to take accountability for their work and own the outcome.
• A space to grow by encouraging and supporting curiosity and an open mindset.
• A culture that prioritizes safety and well-being, both physically and mentally.
• Barrier-free communities within our organization where every employee is equally valued and respected – regardless of their background, beliefs, or identity.
• A firm belief that working together with our stakeholders and suppliers is key to achieving great things.
• An eagerness to be one team and learn from each other to bring progress to life and create a better future.

You bring:

• University degree in Pharmacy is a must, registered within SAPC, since the holder of the position will act as Responsible Pharmacist.
• Seasoned Regulatory Affairs professional with in-depth knowledge and established network at SAHPRA and ideally with other regulatory authorities in the SSA region including Nigeria, Kenya, and Ethiopia.
• Experience in pharma, health supplements, and/or food legislation in the Africa region.
• Interdisciplinary knowledge in Quality Standards, registration procedures for ingredients and complementary medicines/health supplements, GMP, and GPP rules.
• Customer orientation with strong aptitude for proactively identifying needs and defining solutions. Strong verbal and written communication skills.
• Able to perform in a fast-paced work environment where constant re-prioritization is required.
• Passionate about preventative health care.
• Fluent in English; any other language (e.g., French) is a plus.

Equal opportunities commitment:

dsm-firmenich is fully dedicated to inclusion because when people feel engaged and empowered, their creativity and innovation drive unprecedented progress. We aim to build a workplace where opportunity really is equal, so everyone can thrive. We do not discriminate; there’s a place for everyone at dsm-firmenich.

dsm-firmenich is an Equal Opportunity and Affirmative Action Employer. We are committed to providing reasonable support for disabled applicants in our recruiting process. Should you need assistance, and are comfortable to share this, please let us know.

About dsm-firmenich:

As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world’s growing population to thrive. With our comprehensive range of solutions, natural and renewable ingredients, and renowned science and technology capabilities, we work to create what is essential for life, desirable for consumers, and more sustainable for the planet.

dsm-firmenich is a Swiss-Dutch company, listed on the Euronext Amsterdam, with operations in almost 60 countries and revenues of more than €12 billion. With a diverse, worldwide team of nearly 30,000 employees, we bring progress to life every day, everywhere, for billions of people.

www.dsm-firmenich.com