Senior Director, Regulatory Affairs Strategy

2 months ago

Plainsboro, New Jersey, United States Genmab Full time
Job Description

At Genmab, we're committed to building extraordinary futures together, by developing innovative products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases.

We believe that being uniquely talented, determined to be our best, and authentic is essential to fulfilling our purpose.

The Role

Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.

In this role, the regulatory leader will be primarily responsible for the development of US regulatory strategies and have the role of Global Regulatory Strategist to advance Genmab's portfolio of development and marketed drugs.

This individual will provide strategic input and ensure operational execution of US submission activities and work collaboratively with Regional Regulatory Strategists with responsibilities exUS.

The individual will interface directly with the US FDA as the primary contact for assigned programs.

Importantly, the chosen candidate will manage and mentor a group of Regulatory Affairs strategists.

Responsibilities:

  • Act as the US/Global Regulatory Leader (GRL) for assigned project(s) and be responsible for the development, implementation, and maintenance of 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 (e.g., orphan drug designation, breakthrough therapy designation, Fast Track, accelerated approval, compassionate use, pediatric plans, diversity action plans) 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. The US/GRL will lead and/or 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.

Requirements:

  • 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

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