Junto HLS is working exclusively with our client on an Associate Director, Vaccines Regulatory Affairs CMC Strategy position (top-tier pharma company). This individual will provide program oversight and CMC regulatory strategy to global vaccine programs in various stages of development.
- Independently plans, executes and manages regulatory submissions for assigned vaccines in various phases of clinical development, global marketing applications, and post-approval life cycle activities, as needed.
- 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 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 risks 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.
Select Education, Behavioral Competencies and Skills:
- BS/BA Degree in a scientific/engineering discipline required, Advanced Degree preferred.
- 8 + years Regulatory CMC experience (some vaccines or biologics experience required). Alternatively 5+ years Regulatory CMC experience combined with 3+ years relevant vaccines or biologics experience (e.g. Pharmaceutical Development, Process Development, Analytical Development, Production, Quality Assurance).
- Proven ability to liaise with Regulatory Agencies in Agency Interactions and product development meetings, global experience preferred. Demonstrated track record for successful interactions with FDA and preferably other global health authorities related to CMC submissions.
- Understanding of scientific principles and regulatory CMC requirements relevant to global vaccine development, registration, and post-market support. Proven ability to provide strategic regulatory guidance to teams.
- Experience with process development, analytical characterization, process scale-up and/or regulatory registration of biological drug substances or drug products (including sterile parenteral dosage forms) is required.
- Excellent written and oral communication skills required.
- 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 Michelle@juntoHLS.com.