Roles & Responsibilities :
- Develop global or US regulatory strategy for Oncology products in development and through life cycle management, considering all relevant guidance, commercial needs, and company objectives.
- Develop strategic direction and provide leadership for all regulatory interactions with FDA / global regulatory authorities.
- Lead regulatory dossier submissions to global and / or FDA (IND, BLA, NDA, and supplements) utilizing internal and external resources;
ensure appropriate quality controls in place for compliant submissions.
Writing regulatory documents ( new INDs, briefing book content, BT Designation request, Priority Review Requests, ODD);
reviewing core documents to support IND / BLA / NDA, in conjunction with EUL or GRL as needed.
- Provide strategic direction (and content input) on US Labelling.
- Anticipate and interpret key trends and changes in the global / US regulatory environment and provide strategic guidance regarding development plans as a result.
- Foster positive relationships with FDA.
- Build and maintain a strong, collaborative relationship with all key stakeholders including Commercial, Medical Affairs, Promotion & Compliance, Global Development, and other functions key to the success of product development.
- Interact routinely and will develop a strong team environment with colleagues throughout GRS.
Education & Experience :
PharmD., MS or commensurate experience.
- Significant experience in regulatory affairs (, - years).
- Expert understanding of policy, laws, regulations, and guidelines as they apply to
- FDA for drug development and approval.
- Expert understanding of drug development process and understanding of scientific content and complexities related to a project in Oncology.
- Direct experience in developing strategy and leading teams through interactions with FDA.
- Extensive experience in initiating and conducting successful interactions within FDA.
- Strong ability to work successfully in a matrix environment and to lead teams successfully toward drug approvals.
- Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional, and geographic boundaries to achieve company goals.
- Communicates opinions, facts and thoughts with clarity, transparency, and honesty.
- Demonstrates ownership of results within (and beyond) area of responsibility.
- Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
- Looks for opportunities for continuous improvement.
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