Associate Director, Regulatory Affairs Associate Director, Regulatory Affairs …

Hamlyn Williams
in Philadelphia, PA, United States
Permanent, Full time
Be the first to apply
Competitive
Hamlyn Williams
in Philadelphia, PA, United States
Permanent, Full time
Be the first to apply
Competitive
Associate Director, Regulatory Affairs
Associate Director, Regulatory Affairs

Reports to the SVP of Regulatory

Works 2-3 days a week in the office located in the greater Philadelphia Area

The Associate Director, Regulatory Affairs is responsible for overseeing and directing all regulatory activities for the product pipeline, including new gene therapy products, vaccines, and other biological products, to ensure alignment and compliance with local and international registration requirements as well as with company policies.

Duties and responsibilities
  • Develop and implement strategies for timely submission and approval of regulatory submissions which include pre-IND and other milestone meetings with regulatory agencies
  • Coordinate with internal and external teams to author pre-clinical submissions, INDs, Clinical trial protocols, marketing applications, and other as needed regulatory applications, etc.
  • Represent Regulatory Affairs in internal and external (vendor) meetings
  • Coordinate with third party submission group to file applications via gateway submissions and establish timelines
  • Work with internal departments and/or vendors to facilitate deviations, change controls, CAPA closures, investigations, etc. to ensure a rapid and appropriate response to quality related matters
  • Perform data analyses, prepare quality trend/metrics and prepare quality reports as needed
  • Ensure appropriate and consistent audit reporting and non-compliance resolution
  • Provide leadership as required internally and externally regarding quality interpretation of regulatory requirements
  • Lead and support various Regulatory Affairs and cross-functional activities/projects, as needed
  • Ensures timely preparation of organized and scientifically valid applications
  • Provides expertise in translating regulatory requirements into practical, workable plans
  • Interacts with regulatory agencies.
  • Selects, develops, and evaluates personnel to ensure the efficient operation of the function
Qualifications include:
  • BS, MS, or PhD with focus in Life Sciences field
  • 6+ (BS), or 4+ (MS), or 2+ (PhD) years of relevant and current work experience in pharmaceutical regulatory required
  • Advanced knowledge of manufacturing, clinical and analytical services in the pharma industry, vaccine and/or gene therapeutic regulatory knowledge preferred
  • Solid and demonstrable knowledge of GMP, GLP and GCP international regulations
  • Proven background in risk and regulation management, mitigation, and compliance
  • Strong organization and time management skills
  • Attention to detail with an ability to perform critical review of various types of documents
  • Outstanding communication skills and demonstrated ability to work as a team player on multi-disciplinary project teams
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