My client is and established global biopharma company that has retained us to find top-tier candidates for a new Global Regulatory Affairs Director (or Sr. Director) role within their science-driven and patient-focused organization. In this newly created position you will be leading US and Global regulatory strategies for assigned oncology programs from development through commercialization. This is a highly visible role where you will be working closely with senior management and collaborating with a number of cross-functional stakeholders.
- Develop asset-specific regional and/or global regulatory strategies for designated oncology programs.
- Ensure that regulatory strategies will deliver the needs of the local regions, taking in to account the needs of other regions globally.
- Lead interactions with local and regional regulatory authorities.
- Implement regional strategies in support of the projects globally.
- Ensure appropriate interaction with regional commercial teams in local regions.
- Ensure compliance with regional requirements at all stages of product life.
- Keep management team informed of regulatory status of projects and any risks/issues;
- Facilitate dialogue between team and matrix members so they understand links between their different ideas and perspectives.
- Anticipate and plan for changes in the evolving regulatory environment and policy/regulations; develop and implement risk mitigation strategies as appropriate.
Knowledge and Skills:
- Scientific Degree (MS, Pharm D, Ph.D.) required.
- 7-10 years of biopharma industry experience with at least five years within global regulatory affairs.
- Significant regulatory experience in product development and life-cycle management.
- Clinical regulatory experience with oncology programs is required.
- Extensive knowledge of clinical trial and licensing requirements in the US, Europe and other major markets.
- Experience filing and maintaining INDs and CTAs plus hands-on involvement in NDAs, BLAs, or MAAs a plus.
- Direct experience with global health authority interactions and success obtaining licenses in different geographic areas.
- Must work well in a matrix environment