Junto HLS is working directly with Leadership at a Top 20 pharma to recruit a Director, Global Regulatory Affairs CMC – Biologics.
- Required – Biologics and/or Vaccines experience
- Participates in the development of regulatory CMC development and registration strategies as the RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams for assigned products throughout clinical development and commercial lifecycle. Ensures global strategies are successfully executed across both new product development and existing portfolio life cycle management.
- Interfaces cross-functionally both within the regulatory affairs team as well as with commercial, clinical development, global marketing, quality, etc to ensure that data are identified, obtained and effectively presented for the registration of products world-wide.
- Demonstrates leadership and comprehensive understanding of global RA CMC regulations and guidelines by applying interpersonal skills and expert RA CMC knowledge to address and overcome challenges that arise during development and commercialization
- Successfully communicates and negotiates with international Health Authorities as necessary, directly and indirectly.
- Provides CMC regulatory expertise for new business development/due diligence activities
- Independently plans, executes and manages regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities
- Member of global project teams which require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization. Recommends direction for key operations and new initiatives in collaboration with local and global stakeholders.
- Leads, ensures and/or enhances regulatory compliance with respect to filing requirements for assigned compounds throughout development and the commercial life cycle.
- Manages and develops staff, if required, including staff professional development and project oversight accountability
- Defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements
- Represents company RA CMC in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters
- Interacts directly with international Health Authorities, as required. Participates in agency meetings and may facilitate, depending on experience.
- Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner
- Stays abreast of current and evolving regulatory CMC requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development
- Evaluates change proposals for regulatory impact and filing requirements
- Develops and maintains constructive relations with key internal and external colleagues
- Greater Boston, MA
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.