Junto HLS has been exclusively engaged by Regulatory Leadership at a Top 20 pharma to recruit an Associate Director, Regulatory Affairs CMC Strategy.
- Continue building your Biologics and/or Vaccines RA CMC expertise
- Directly report to the Head of RA CMC – An experienced leader focused on people development
- This position will support an initial BLA filing
- Work on impactful, life-saving medications, well positioned vs. unmet medical need and competitors
- Biologics and/or Vaccines experience (Required)
- Provides program oversight and CMC regulatory strategy to global vaccine programs in various stages of development
- Plans, executes and manages regulatory submissions for assigned vaccines in various phases of clinical development, global marketing applications, and post-approval life cycle activities
- Leads regulatory compliance assessment with respect to filing requirements for assigned vaccines throughout development and the commercial life cycle
- Represents client 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
- 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 controls for regulatory impact and filing requirements
- Develops and maintains constructive relations with key internal and external colleagues, external partners, professional organizations, and Health Authority representatives
- 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.