Regulatory Strategist Oncology (D06)
Regulatory Strategist Oncology
- In close partnership with the global regulatory strategist (GRTL) and regional strategists/liaisons develop strategic and operational plan for the development and the registration of assets across oncology.
- Develop contingency plans for achieving regulatory objectives with associated risks and mitigation strategies in conjunction with GRTL.
- Propose approaches to resolve regulatory issues and appropriately drive speed to patients.
- Support global health authority interactions by preparing objectives for meetings, outline of briefing material, facilitating content discussions and input. Contribute to building a strong and trusted relationship with Health Authorities.
- Understanding of scientific content, drug development and regulatory requirements.
- Analytical skills with regard to assessment of regulatory precedence and regulatory scientific guidelines. Lead identification and compilation of regulatory lessons learned, bringing the appropriate regulatory and clinical experts together, eg registrational program precedents, integrated summaries of EPARs and SBOA, Main messages from a competitor AdCom.
- Track schedules and attendance of relevant Public-Private regulatory meetings or FDA workshops.
- Proven flexibility in adapting to new therapeutic areas and partnering with outside and internal experts.
- Contribute to one regulatory voice to key stakeholders internally and externally (operational partners, health authorities).
- Facilitate identification of and internal agreement on target labeling
- 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
- Seeks multiple perspectives and listens openly to others' points of views.
- Enables and demonstrates the courage to speak up on issues and risks as well as on the good news.
- 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.
- Demonstrates resilience and perseverance.
- Solid scientific background, Ph.D., M.D., PharmD or equivalent professional experience with at least 2 years of relevant regulatory experience.
- A basic knowledge of (i) drug development and (ii) policy, laws, regulations and guidelines as they apply to the FDA for drug development and approval is required. Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers within in a cross-functional environment. Proven ability to work with outside partners.
- Demonstrated ability to be solution-oriented