Junto HLS has been engaged by Leadership at a Top 20 pharma to recruit a Director, Regulatory Affairs CMC – Vaccines.
- Required – Biologics and/or Vaccines experience
- Provides program leadership and develops CMC regulatory strategy for global vaccine programs in various stages of development.
- Leads planning, execution, and management of regulatory submissions for assigned vaccines in various phases of clinical development, global marketing applications, and post-approval life cycle activities.
- Member of technical development teams which require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization.
- Leads regulatory compliance assessment with respect to filing requirements for assigned vaccines throughout development and the commercial life cycle.
- Defines CMC content (data and documentation) requirements for regulatory submissions and compiles/reviews this content for conformance with established requirements.
- Represents company RAV 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 and/or leads agency meetings.
- Ensures project team colleagues, line management, and key stakeholders are apprised of risks that may impact regulatory success, exercising sound judgment 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.
- May serve as direct/matrix manager of up to 4 RAV CMC staff, depending on project. Responsible for prioritization of workload and professional development of staff.
- 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.