Senior Director, Regulatory Affairs Strategy NJ
6 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 NJ. This is a critical role that will play a key part in ensuring compliance with global regulations and driving the growth of our company.
Key Responsibilities- Develop, implement, and maintain US/global regulatory strategies across all stages of development.
- Lead, manage, and mentor a team of regulatory professionals to ensure timely and successful submissions of drug applications to global regulatory agencies.
- Evaluate regulatory risk and recommend mitigation strategies to ensure optimal regulatory success.
- Provide expertise and guidance on global regulatory requirements, guidelines, and changes that may impact the company's products.
- Prepare and review regulatory submissions, including INDs, (s)BLAs for accuracy, completeness, and compliance with regulations and guidelines.
- Evaluate various regulatory mechanisms to optimize product development and ensure that they are implemented, if applicable.
- Consult with senior management to develop and communicate regulatory strategies and recommendations for products and programs.
- Interact with US FDA for assigned projects and lead/participate in meetings with FDA and other health authorities as appropriate.
- Provide expertise and guidance on regulatory requirements, guidelines, and changes that may impact the company's products.
- Build strong relationships with key external stakeholders, including regulatory agencies, professional societies, and key opinion leaders.
- Participate in review of and comment on regulatory guidance as relevant.
- Drive continuous improvement initiatives to enhance regulatory processes, systems, and capabilities.
- BSc or MSc level degree preferably within the life sciences (PharmD, PhD, or MD preferred).
- Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred).
- Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA).
- A broad knowledge of development and life-cycle management is preferred.
- Strong strategic skills, including the ability to make complex decisions and willingness to support difficult positions.
- Solid knowledge and understanding of global and US regulations and the US pharmaceutical commercial landscape.
- Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance.
- Direct hands-on experience with preparation and submissions of IND, (s)NDA/BLA to US FDA.
- Experience with labeling and PMC/PMR negotiations with US FDA.
- Ability to work well within cross-functional teams.
- Strong communication skills – both oral and written.
- Ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans.
- Ability to influence others and resolve conflicts.
- Cultural awareness and respect for diversity.
- Unquestionable ethics, professional integrity, and personal values consistent with the Genmab values.
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative, and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies, and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSOTM) antibody medicines.
Why Join UsWe are committed to fostering workplace diversity at all levels of the company and believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website.
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