Global Regulatory Affairs Manager

6 days ago

Kastrup, Denmark Ferring Pharmaceuticals Full time

Global Regulatory Affairs Manager - CMC

About the Role:

Ferring Pharmaceuticals is seeking an experienced Global Regulatory Affairs Manager to join our CMC team. As a key member of our team, you will be responsible for the lifecycle projects for one of our products, working closely with stakeholders, project teams, and colleagues within global regulatory affairs.

Key Responsibilities:

  1. Develop and implement CMC regulatory strategies and plans to support worldwide market expansions and approvals.
  2. Provide regulatory CMC expertise to cross-functional teams, including Global Regulatory Project Teams, CMC Teams, Product Teams, and Launch Teams.
  3. Perform regulatory impact assessments of CMC changes for development projects and established products, ensuring timely submission and approval worldwide.
  4. Drive and execute Scientific Advice with national Competent Authorities in relation to CMC activities.
  5. Participate in development and optimization of departmental and working processes.

Your Background:

We are looking for a highly skilled and experienced professional with a strong background in global regulatory affairs, preferably in regulatory CMC activities. You should have a M.Sc. in a life science or pharmacy and excellent communication and negotiation skills. Experience in facilitating risk management discussions and a proactive mindset are also essential.

Our Company:

Ferring Pharmaceuticals is an international company with a strong commitment to innovation and development. We offer an open and collaborative work environment, excellent development opportunities, and a chance to make a real difference in the lives of our patients. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.

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