Regulatory Affairs Director

3 weeks ago

Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

Precision Medicine Regulatory Strategy

As a key member of the Gilead Sciences International, Ltd. team, you will develop and execute regulatory strategies in alignment with the drug global regulatory strategy. You will collaborate with cross-functional stakeholders across the company's therapeutic areas and in compliance with relevant regulations. Your mission will be to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with the biomarker team and global/regional regulatory liaisons to provide global regulatory guidance. You will be responsible for regulatory strategy and support, ensuring communication of a clear vision for the translational discovery, development, and validation of biomarkers in clinical studies. Your operational and technical regulatory assistance will be required through all stages of clinical development through global registration for IVD projects. Additionally, you may be involved in the identification of predictive biomarkers that may influence drug product's clinical development strategy and proof of mechanism.

Responsibilities:

  • Represent Regulatory Affairs precision medicine subject matter expertise on cross-functional/cross-regional Regulatory Teams and other Sub-teams involved with the development and validation of IVDs (e.g., Study Management, Clinical, Biomarkers) and present to senior leadership as required.
  • Develop, lead, and communicate a business plan to and implement high-quality globally aligned precision medicine regulatory strategies to support Gilead assets from early development through registration and represent Gilead in key interactions with Health Authorities.
  • Maintain a current understanding of global IVD/CDx regulations, assess, and communicate their impact on drug and IVD/CDx development & registration activities, respectively.
  • Provide IVD regulatory input during clinical development to ensure compliance of diagnostics used in therapeutic trials with global and local regulatory requirements (such as US FDA and EU IVDR).
  • Provide regulatory strategy relative to premarket submission, IVD partnering, FDA and other Health Authority interface, regulatory policy, and practice.
  • Lead the preparation and filing of HA briefing books, including coordination and planning for pre-Submission meetings with FDA and IDEs. Provide inputs on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs, device clinical performance study applications, and labeling for drug and diagnostic products.
  • Manage internal and external stakeholders to advance scientific and technical capabilities to design and execute translational research and precision medicine across all therapeutic areas.
  • Contribute to local and/or global process improvements which have a significant impact on business.
  • Support or lead training related to the IVD/CDx development & registration activities.
  • Ensure compliance with established practices, policies, processes, and any regulatory or other requirements.
  • Represent Gilead with trade organizations, with travel to key meetings on an annual basis.

Requirements:

We are all different, yet we all use our unique contributions to serve patients. For this role, we seek individuals with a BA/BS or advanced degree in life sciences or a related field, with significant regulatory experience in the biopharma industry, regulatory agency, clinical research, or other related healthcare environment. Experience in in vitro diagnostic development is strongly preferred.

Knowledge & Other Requirements:

  • Demonstrated ability to be a fast learner.
  • Demonstrated ability to be flexible and adaptable to change, to move between projects easily, and provide support/expertise where needed.
  • Demonstrates advanced knowledge of regulatory requirements (including those related to IVDs, notably IVDR) and the role of regulatory affairs in achieving cross-functional drug discovery and development goals and objectives.
  • In-depth knowledge of relevant health authorities, including people, system, processes, and requirements, as evidenced by past effectiveness and successes in conducting HA interactions.
  • Able to represent Gilead to regulatory authorities when managing standard or more routine negotiations.
  • Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills, and proficiencies with Microsoft Office suite, as evidenced through accomplishments in past roles.
  • Ability to lead and influence programs, projects, and/or initiatives.
  • Strong interpersonal and communication skills with the ability to rapidly understand and navigate team dynamics.
  • Proven ability to work successfully in a team-oriented, matrixed environment.
  • When needed, ability to travel.

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