Senior Manager - Regulatory Affairs

Location
Indianapolis, Indiana
Salary
Commensurate with experience
Posted
Aug 02, 2019
Ref
RegAffairsUS
Required Education
Bachelors Degree
Position Type
Full time

Responsibilities:

  • Develops regulatory strategies to expedite FDA review and approval of drug submissions in conjunction with Director, Regulatory Affairs and Quality
  • Leads preparation and interactions (e.g., IND, pre-NDA/BLA, advisory committee meetings, etc.) with the FDA and other foreign health authorities (e.g. Canada, EU) on behalf of all Telix development programs and products
  • Lead regulatory operations, coordinates and directs the resources in preparation of and timely submissions to the FDA and other health authorities in support of development programs
  • Maintains regulatory compliance for INDs, CTAs and NDAs/MAAs
  • Cross-functionally partners with colleagues in to manage regulatory activities in preparation of submissions and translate regulatory requirements into pragmatic and strategic strategies and plans
  • Plan, write, and review Health Authority document submissions (e.g. Briefing Documents)
  • Assist in the development and manage annual regulatory budget
  • Remain well-informed of key global guidance documents, regulations, or directives. Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
  • Support relationships with regulatory and legislative agencies, globally addressing the scientific and medical/health aspects of the company‚Äôs product portfolio
  • Develop and manage the global Regulatory function within Telix

Qualifications, Skills and Experience:

  • Experience: Candidates should have a minimum of 7-10 years of experience in pharmaceutical drug development as a regulatory lead ideally with US and EU filings (BLA, NDA, MAA) preferably with biologics background
  • Knowledge of global (US and EU) drug development regulations and guidelines; experience in interactions with regulatory authorities
  • Well-developed leadership and project management skills, including demonstrated cross-functional communication, interpersonal and influence management skills