Assistant Regulatory Affairs Manager
September 25, 2024 11:00 pm
HealthActiv is presently looking for an Assistant Regulatory Affairs Manager who will provide support on Regulatory Policies, Contracts, Pharmacovigilance, and Good Distribution and Storage Practices to assist the companies within the Cluster to achieve overall organisational regulatory, supplier contract and commercial objectives.
Key Responsibilities
- Strategic Management: Continuously improve strategies, systems and processes relating to regulatory and GDP/GSP requirements to ascertain business continuity within the local and international legal framework.
- Operations: Lead and manage the day-to-day planning and execution of the Regulatory Affairs Department.
- Regulatory: Assist in the preparation, compilation, and submission of regulatory documents for the registration/renewal of products.
- Quality: Ensure adherence to the WHO GDP/GSP specifications and Quality Audits.
- Contract Management: Drive the process for the administration of contracts and ensure the timely renewal of agreements.
- Cross-functional Collaboration: Provide regulatory guidance to concerned departments to ensure regulatory requirements are integrated into work processes.
- Business Development: Assist in the identification of new business development opportunities within the local and international markets.
Qualifications & Experience
- Registered Pharmacist with at least 10 years of experience as a Registered Pharmacist. Post graduate Degree/Diploma would be an advantage.
- At least 5 years of Regulatory, GDP/GSP quality and business experience within the pharmaceutical industry will be an advantage.
Other Requisites
- In-depth understanding of regulations and guidelines relating to the pharmaceutical industry.
- Excellent planning and organisational skills.
- Strong communication, presentation and negotiation skills.
- Demonstrate honesty and ethical behaviour in all areas of responsibility.
- Ability to troubleshoot regulatory issues and find compliant solutions.
- Ensure due diligence in all processes.
Contact
Human Capital Department