Regulatory Expert
11 hours ago
About the Role
We are seeking an experienced Regulatory Affairs Professional to join our team as a Global Regulatory Lead. This challenging position will involve driving the development of innovative therapies for diseases within Reproductive Medicine & Maternal Health and Uro-Oncology therapeutic areas.
Ferring Pharmaceuticals A/S is dedicated to advancing treatments that help people live better lives. Our approach encompasses a diverse range of treatment solutions, and we strive to lead in innovation while adopting a global perspective from early development stages.
In this role, you will leverage your extensive regulatory expertise to drive the progression of our development projects and/or key marketed products within these fields. You will work closely with colleagues across the global functions and regional offices to deliver high-quality results.
Key Responsibilities
- Represent GRA in the Global Project Team and chair the Global Regulatory Teams providing regulatory strategic expert input to drive project/product progression.
- Develop and execute global regulatory strategies, including worldwide submission planning, market expansions, and label expansions.
- Plan and manage meetings with health authorities worldwide for the projects/products assigned.
- Lead the preparation of high-quality briefing packages and liaise with health authorities and experts to obtain scientific advice to mitigate regulatory risks.
- Ensure submission and approvals of BLAs/MAAs in US, EU, Japan, China, and other countries worldwide.
- Prepare the regulatory LCM strategy and manage the strategic planning and execution of regulatory submissions and approvals for worldwide market expansions, renewals, and variations.
- Compile, submit, and approve CTAs and INDs for all clinical trial-related regulatory activities.
- Provide regulatory input to evaluation of external business opportunities (due diligence).
Requirements
- University degree in science (life science, health, or medical sciences).
- + 8 years of comprehensive experience with drug development from phase 1 to launch, including health authority interactions (FDA, EMA, Japan, and China).
- Experience with labelling, clinical trials, and other clinical and non-clinical regulatory activities.
- Strong negotiation skills, solid judgment, and effective decision-making abilities.
- Able to work in an international corporate environment with a diverse and fast-paced workday.
- Fluency in English, excellent verbal and written communication skills.
About Ferring
Ferring Pharmaceuticals A/S is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. At our International PharmaScience Center in Copenhagen, we focus our R&D efforts on peptide-based drugs and biotechnology-derived medicines.
Culture at Ferring
We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status. People come first at Ferring, and we prioritize our employees' well-being, growth, and development.
Location
This role is based in our headquarters in Copenhagen, Denmark, offering a unique opportunity to work in a dynamic international environment with close collaboration across global functions and regional offices.
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