Manager, Regulatory Affairs (Alachua, FL)

Employer
AGTC
Location
Alachua, FL, United States
Posted
Aug 14, 2019
Ref
1337848795
Required Education
Bachelors Degree
Position Type
Full time
The Manager, Regulatory Affairs is responsible for executing company regulatory strategies in compliance with established regulations and guidelines, including the on-time filing of high-quality regulatory submissions.

Reporting Relationship

  • The Manager, Regulatory Affairs will report to the Executive Director, Regulatory Affairs.

Supervisory Responsibilities

  • This position does not have supervisory responsibilities

Essential Duties and Responsibilities

  • Participate in the development and implementation of regulatory strategies for AGTC's therapeutic programs from candidate selection through post-marketing support
  • Provide guidance to inter-disciplinary project teams on product development approaches and regulatory submission requirements
  • Coordinate the drafting, editing, preparation and submission of regulatory submissions (including routine correspondence, INDs, BLAs, Annual Reports, Amendments, Supplements, Orphan Drug Applications, etc.) with minimal oversight
  • Liaise with regulatory authorities as directed to further product development programs and keep them in good standing
  • Maintain current knowledge of FDA and international regulations, guidance and standards applicable to company products
  • Assist in the maintenance of corporate quality systems in line with current GxP standards, regulations and company directives
  • Other duties as assigned

Requirements

  • B.S., and at least five (5) years of experience working in biomedical research field
  • M.S. or Ph.D. degree in a scientific discipline and experience working with biotechnology products preferred
  • Knowledge of GCP, GLP, GMP and FDA and ICH guidelines
  • Understanding/working knowledge of Microsoft Word and Excel
  • Strong interpersonal, negotiating and problem-solving skills
  • Excellent communication skills, both written and verbal

AGTC offers a competitive compensation commensurate with education and experience, including salary, benefits, and company equity. AGTC is an EOE and maintains a drug free workplace. Please send CV or resume to jobs@agtc.com