Senior Director, Regulatory Affairs Strategy
5 days ago
Genmab is seeking an experienced and passionate leader to join our Global Regulatory Affairs (GRA) organization as a Senior Director, Regulatory Affairs Strategy. In this role, you will be responsible for developing and implementing US regulatory strategies and advancing Genmab's portfolio of development and marketed drugs.
Key Responsibilities- Regulatory Strategy Development: Develop and implement US regulatory strategies for assigned projects, ensuring compliance with global regulations and driving the growth of our company.
- Team Leadership: Lead, manage, and mentor a team of regulatory professionals to ensure timely and successful submissions of drug applications to global regulatory agencies.
- Regulatory Risk Management: Evaluate regulatory risk and recommend mitigation strategies to ensure optimal regulatory success.
- Regulatory Expertise: Provide expertise and guidance on global regulatory requirements, guidelines, and changes that may impact the company's products.
- Submission Preparation: Prepare and review regulatory submissions, including INDs, (s)BLAs, for accuracy, completeness, and compliance with regulations and guidelines.
- Regulatory Mechanisms: Evaluate various regulatory mechanisms to optimize product development, such as orphan drug designation, breakthrough therapy designation, Fast Track, accelerated approval, compassionate use, pediatric plans, diversity action plans.
- Stakeholder Engagement: Interact with US FDA for assigned projects, leading and/or participating in meetings with FDA and other health authorities as appropriate.
- Continuous Improvement: Drive continuous improvement initiatives to enhance regulatory processes, systems, and capabilities.
- Education: BSc or MSc level degree preferably within the life sciences (PharmD, PhD, or MD preferred).
- Experience: Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred).
- Skills: Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA), strong strategic skills, ability to make complex decisions, and willingness to support difficult positions.
- Knowledge: Solid knowledge and understanding of global and US regulations, the US pharmaceutical commercial landscape, complex medical and scientific subject matter, and evolving regulatory policy and guidance.
- Leadership: Ability to work well within cross-functional teams, strong communication skills, ability to use appropriate interpersonal styles and techniques, and ability to influence others and resolve conflicts.
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