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 or 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 
  
  Back