Job description - Head Regulatory Affairs
Alternative job titles
Director Regulatory Affairs
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 Head Regulatory Affairs should have held a Regulatory Affairs Management position with line management responsibilities and preferably international experience.
Competencies
- Initiate marketing strategies and coordinate actions to influence the market
- Make strategic decisions
- Leadership skills including recognising the strengths and weaknesses in others as well as oneself
Tasks
- Responsible for the strategy of the RA department
- Develop & maintain regulatory knowledge of European regulations
- Managing a team that consists of several regulatory affairs managers & officers
- Defend company business interest in international standardization groups
- 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
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