Job description - Regulatory Affairs Manager
Alternative job titles
Senior Regulatory Affairs Executive
Description
The Regulatory Affairs Manager is responsible for the leadership and support of the Regulatory personnel. He/she participates in all activities relating registration requirements and line extension indications.
Qualifications
A candidate for the Regulatory Affairs Manager position should preferably be in possession of a degree in pharmacy and have extensive experience in the regulatory field. In order to be a successful manager, the candidate should be familiar with a variety of the fields’ concepts, practices, and procedures
Competencies
- Keep up to date with market trends and new developments utilising information for business improvement
- Understand and develop long term business vision
- Careful delegation of tasks whilst maintaining responsibility for final result
- Careful planning to achieve accurate and timely results
- Ability to discuss strategic and sensitive issues
- Recognise recurring issues and analyse their causes in order to reach a solution
Tasks
- Responsible for coordination & preparation of regulatory submissions and strategies
- Develop & maintain regulatory knowledge of European regulations
- Managing a team that consists of several regulatory affairs officers
- Manage the final product submissions and negotiate and communicate effectively with regulatory authorities to obtain timely product approvals
- Participate in product teams with regard to implementation of regulatory requirements
- Defend company business interest in international standardization groups
- Manage transposition of international standards into company product related requirements
- Provide the Project teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning
- Implement QA systems and generate SOPs
- Update licensing and collect information on registration instructions and regulations
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