Director, Regulatory Affairs Strategy

2 weeks ago

Plainsboro, New Jersey, United States Genmab Full time
Job Title: Director, Regulatory Affairs Strategy

Genmab is seeking an experienced and passionate leader to join our Global Regulatory Affairs (GRA) organization as a Director, Regulatory Affairs Strategy. In this role, you will be responsible for developing and implementing global and US regulatory strategies to advance Genmab's portfolio of development pipeline candidate drugs.

Key Responsibilities:
  • Develop and implement global and US regulatory strategies to advance Genmab's portfolio of development pipeline candidate drugs.
  • Provide strategic input and ensure operational execution of global and US submission activities.
  • Interface directly with the US FDA as the primary contact for the company for assigned programs.
  • Lead the Global Regulatory Team (GRT) and Submission Team(s).
  • Evaluate regulatory risk and recommend mitigation strategies to the cross-functional teams and management.
  • Lead the strategic development of briefing materials and prepare teams for US/global health authority meetings.
  • Participate in the development and review of submission documentation to support successful INDs/CTAs as well as marketing applications (e.g., BLAs/MAAs).
  • Evaluate competitive landscape and various regulatory mechanisms that allow optimization of product development (e.g., orphan drug designation, breakthrough therapy designation, Fast Track, accelerated approval, pediatric plans) and present options and recommendations to expedite the path to market, as applicable.
  • Collaborate with the Labeling team to develop the Company Core Data Sheet and US Prescribing Information depending on the assigned project(s).
  • Consult with senior management to develop and communicate regulatory strategies and advice for products and programs.
  • Interact with the US FDA and global health agencies for assigned project(s).
  • Monitor and assess regulatory guidelines, regulations, and current regulatory environment/landscape, and their impact on the development of Genmab products.
  • Maintain an updated knowledge of regulatory topics and regulations and participate in maintaining and preparing regulatory processes and ways of working.
  • Build strong relationships with key external stakeholders including regulatory agencies, professional societies, and key opinion leaders, as relevant.
  • Participate in review of and comment on regulatory guidance as relevant.
  • As assigned by management, provide regulatory due diligence assessment of licensing/acquisition opportunities.
Requirements:
  • BSc or MSc level degree preferably within the life sciences (PharmD, PhD preferred)
  • Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred)
  • Prior experience of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA)
  • A solid understanding and experience in drug development including early and late development is highly preferred.
  • A broad knowledge of life-cycle management is highly preferred.
  • Strong strategic skills including the ability to make complex decisions
  • Solid knowledge and understanding of global and US regulations and the US pharmaceutical market
  • Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance
  • Strong organizational, communication (both oral and written), and time management skills needed to manage multiple ongoing projects/tasks simultaneously.
  • Must have attention to detail and be able to solve problems with minimal supervision.
  • Be able to work independently with an ability to drive projects to successful outcomes.
  • Ability to influence others and resolve conflicts
  • Highly motivated and self-driven individual who enjoys being challenged.
  • Unquestionable ethics, professional integrity, and personal values consistent with the Genmab values
About Genmab

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.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

We are committed to fostering workplace diversity at all levels of the company and we 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 https://www.genmab.com/privacy.

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