Global Regulatory Lead
2 months ago
Unlock Your Potential as a Global Regulatory Affairs Professional
Ferring Pharmaceuticals A/S is dedicated to advancing innovative therapies for the treatment of diseases within the Reproductive Medicine & Maternal Health and Uro-Oncology therapeutic areas. We strive to lead in innovation and adopt a global perspective, starting from the early stages of development.
We are seeking an experienced Regulatory Affairs Professional to join our team as a Global Regulatory Lead. This challenging position will enable you to drive the progression of our development projects and/or key marketed products within these fields.
In this role, you will work in a team of highly skilled regulatory professionals responsible for the global regulatory activities for our development projects and marketed products. You will be assigned to one or more projects or marketed products, and your responsibilities may encompass:
- Represent GRA in the Global Project Team and chair the Global Regulatory Teams, providing regulatory strategic expert input to drive project/product progression.
- Drive the development of high-quality global regulatory strategies, including identifying regulatory opportunities and mitigation of risks, strategic submission and regulatory activity planning, and development of competitive labels in collaboration with relevant team members and stakeholders.
- Plan and manage meetings with health authorities worldwide for the projects/products assigned, driving and leading the preparation of high-quality briefing packages, liaising with health authorities and experts to obtain scientific advice to mitigate regulatory risks and enable project progression.
- Ensure submission and approvals of BLAs/MAAs in US, EU, Japan, China and other countries worldwide in collaboration with local regulatory colleagues, driving the strategic planning of market expansions, including responses to authority inquiries.
- Prepare the regulatory LCM strategy and manage the strategic planning and execution of regulatory submissions and approvals for worldwide market expansions, renewals, and variations for the products assigned, leading the submission team and chairing the Labelling Management Team.
- Ensure compilation, submission and approval of CTAs and INDs for all clinical trial-related regulatory activities, maintaining these throughout the development phases.
This is a fantastic opportunity to make a real impact on our business and contribute to the development of life-changing treatments. If you are a motivated and experienced Regulatory Affairs Professional looking to take your career to the next level, we encourage you to apply.
About the Role
The successful candidate will have a university degree in science (life science, health or medical sciences) and at least 8 years of comprehensive experience with drug development from phase 1 to launch, including health authority interactions (FDA, EMA, Japan and China). You will have experience managing global regulatory activities and driving regulatory strategic project discussions, including preparing regulatory strategies and submissions. Strong negotiation skills, solid judgement, and effective decision-making abilities are essential for this role.
Your New Workplace
Our office is located in Copenhagen, Denmark, and offers a modern and collaborative work environment. As a valued member of our team, you will enjoy close collaboration with colleagues across the global functions and in our regional and affiliate offices.
Salary Range: €90,000 - €120,000 per annum
Benefits
We offer a range of benefits, including a salary range of €90,000 - €120,000 per annum, parental leave for both birthing and non-birthing parents, and an extended support package for family building. Our inclusive workplace values diversity and promotes equal opportunities for all employees.
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