Global/US Regulatory Leader
Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.
In this role, the regulatory leader will be primarily responsible for the development of global (and US) regulatory strategies (depending on the assigned project) to advance Genmab’s portfolio of development pipeline candidate drugs. This individual will provide strategic input and ensure operational execution of global (and US) submission activities. The individual will be responsible to interface directly with the global health authorities (and US FDA) as the primary contact for the company for assigned programs. This position is based in our Princeton, NJ office.
Reporting to the Vice President, Head of Global Regulatory Affairs the key responsibilities include but are not limited to:
- Act as the Global Regulatory Leader (GRL) for assigned projects. In collaboration with regional regulatory leaders, be responsible for the development of innovative, robust global regulatory strategies (in line with the Target Product Profile) and ensure efficient and effective execution of such strategies for pipeline assets.
- May also be the US regulatory leader (US RL) for an assigned project. In collaboration with the GRL, be responsible for the US regulatory strategy. Represent the US GRA perspective and be accountable to develop and maintain US aspects of regulatory strategy documents.
- Evaluate regulatory risk and recommend mitigation strategies to ensure optimal regulatory success.
- Represent GRA in global Compound Development Teams (CDT) to successfully meet project deliverables while adhering to regulatory requirements for programs and products. May involve members of the GRA team to participate in CDT meetings on ad hoc basis as needed or applicable.
- Lead the strategic development of briefing materials and prepare teams for global health authority meetings.
- Participate in the development of and assess the appropriateness of submission documentation to support successful IND/CTAs as well as BLAs/MAAs.
- Evaluate various regulatory mechanisms that allow optimization of product development (e.g., orphan drug designation, breakthrough therapy designation, PRIME, Fast Track, accelerated/conditional approval, compassionate use, pediatric plans) and ensure that they are implemented, if applicable
- Work to develop Company Core Data Sheet and US Prescribing Information.
- Consult with senior management to develop and communicate regulatory strategies and advice for products and programs.
- Monitor and assess global and US regulatory guidelines and regulations and current regulatory environment/landscape and their impact on the development of Genmab products
- Interact with the global health agencies and US FDA for assigned projects.
- 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
- As assigned by management, provide regulatory due diligence assessment of licensing/acquisition opportunities
Skills & Experience
- BSc or MSc level degree preferably within the life sciences (PharmD, PhD preferred)
- Minimum of 3-5 years of hands on industry experience within Regulatory Affairs (Oncology experience preferred)
- Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA)
- 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 market place
- Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance
- 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
If you are interested in the position, please apply via https://genmab.loop.jobs/job/Genmab-Princeton-New-Jersey/69040551