Hybrid Regulatory Affairs Associate - West Africa Regulatory Affairs Associate - West Africa with verification

The Regulatory Affairs Associate will be responsible for ensuring that the company complies with all the regulations and laws pertaining to the veterinary biologicals business in Africa. He/she works with regulatory agencies and personnel on specific regulatory issues affecting the business. Advises the company on the regulatory aspects and offers the company options based on the proposed activities and protects current markets from regulatory related threats.

Responsibilities

• Product regulatory clearance & registration processes, including compilation of dossiers and ensuring accuracy and completeness of the same. Be accountable for progress & deadlines.
• Keeping track of the ever-changing legislation in all Africa and participate in law making in those regions.
• Developing and facilitating relations with key regulatory authorities and decision-makers at a country level; discussing and challenging issues and negotiating solutions in the best interests of the company.
• Acting as the interface between the company and regulatory authorities on all regulatory affairs.
• Offering advice on scientific restraints and requirements.
• Assist in establishing a network of local consultants/legal entities in the respective countries in Africa, to assist in dossier submission and compliance.
• Ensuring regulatory compliance of all products and take preemptive actions to uphold the integrity and image of the company and its products.
• Supervise the generation and maintenance of product documentation for registration purposes.
• Assist in managing the Intellectual Property & Regulatory Affairs (IPRA) section, strategize registration approaches, execute all activities in support of company direction and strategic plan.
• Assist in managing the product innovation process for Africa: evaluating the potential use of veterinary biological products, giving inputs on registration requirements and timelines, giving strategic inputs on registration details to increase innovation flexibility.
• Reviewing company data before it is presented outside of Kemin for its compliance with branding guidelines and regulatory language.
• Safeguard product formulations and bill of materials on the ERS.

Qualifications

Education level:

• Degree in a technical field (e.g., Veterinary, Pharmaceutical, Biotechnology, Microbiology, Virology). Advanced degree preferred.
• Experience in Regulatory Affairs for biologics or pharmaceutical fields.

Experience:

• Strong record of successful product submission and registrations of Biologicals.
• Excellent technical writing skills to prepare regulatory documentation and connect with Authorities
• Demonstrated project management, negotiation, and communication (written and oral) skills.
• Demonstrated global perspective, customer focus, cross-functional collaboration and teamwork skills.

Specific Skills/competencies/ Training Required

• Strong argumentative with basic legal writing skills
• Strong interpersonal/communication skills

Personal Characteristics

• Ability to develop strong networks and influence internal and external stakeholders.

Certifications

• Registration of Medicines certificate will be advantageous.