Senior Regulatory Affairs Specialist/ Responsible Pharmacist at DSM-Firmenich

Job Description

• This role will be a key contact with the local authorities and trade association as well as a focal point for internal functions who will guide the business through local regulations.

DEI Statement

• At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work, benefiting to our People, Customers & Communities and driving business value. Equal access to opportunities is a given, belonging is a shared feeling, authenticity is celebrated.

Your Key Responsibilities:

• Contribute as a Regulatory Affairs (RA) team member in the joint efforts for the development of the global product approval strategy in a timely and accurate manner.
• Act as Responsible Pharmacist and be the contact for the 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 e.g. SAHPRA, Nigerian National Agency for Food and Drug Administration and Control (NAFDAC), Pharmacy and Poisons Board of Kenya.
• Support customer queries related to food, health supplements and pharma, related to dsm-firmenich products 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 to 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 the 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, Ethiopia.
• Experience in pharma, health supplements and/or food legislation in Africa region.
• Interdisciplinary knowledge in the following areas: 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.