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Regulatory Affairs Director

2 months ago

Germantown, Maryland, United States Precigen, Inc Full time
Job Title: Associate Director, Regulatory Affairs

About the Role:

Precigen, Inc. is seeking a highly motivated and experienced Associate Director, Regulatory Affairs to join our team. This role is responsible for knowledge and application of global regulations governing pharmaceutical drug development. The successful candidate will participate in the development and implementation of regulatory strategies for specific drug development programs (pre and post market approval).

Key Responsibilities:

  • Manage day-to-day Regulatory Affairs activities for investigational and commercial products, serving as liaison between company and FDA and other global Regulatory authorities for assigned programs.
  • Support regulatory strategies for assigned programs, in order to support Precigen's development and marketing objectives.
  • Participate in project team and sub-team discussions regarding preclinical, clinical and CMC aspects of drug development, providing regulatory guidance, communicating regulatory goals and timelines, and helping to ensure compliance to the requirements from U.S. and foreign regulatory agencies.
  • Help to identify and assess regulatory risks, understanding global imperatives including market-related drivers; plans and implements appropriate mitigation strategies.
  • Develop effective professional relationships and promotes a positive company image with FDA and global regulatory authorities.
  • Coordinate regulatory workflow, provides regulatory support and tracks regulatory timelines pertaining to area of responsibility.
  • Manage the planning, preparation and submission process for IND and licensing applications.

Requirements:

  • Bachelor's degree preferably in life science or a related field, advanced degree strongly preferred.
  • Five (5) years of direct regulatory affairs experience in biotech or pharmaceutical environment. RAC is desirable but not required.
  • Comprehensive knowledge of regional health authority regulations and advanced knowledge of global regulations/guidelines governing development of pharmaceuticals, biologics and medical devices.
  • Experience in compilation of Regulatory submissions using eCTD (electronic common technical document) preferred.
  • Demonstrated experience with US BLA/NDA submissions, preferably in oncology/hematology.

Desired Key Competencies:

  • Exceptional leadership, planning, organization, and execution skills.
  • Organized self-starter.
  • Ability to understand and execute on the company's mission and values.
  • Strong analytical and decision-making skills with attention to detail and quality.
  • Exhibits impeccable confidentiality on sensitive, supporting tasks.
  • Ability to anticipate and solve problems while analyzing complex issues and environments.
  • Ability to communicate and work effectively with all levels of employees in various communication mediums.
  • Possess a high degree of personal responsibility.
  • Ability to adapt and succeed in a milestone-driven, rapidly changing product development and commercialization environment.
  • Computer literate with proficiency of Microsoft Office package including Word, Outlook, Excel, and Adobe PDF.

Work Environment:

Administrative office/cubical; some laboratory and manufacturing area access.

  • Frequent: Speaking; hearing; sitting; use of hands/fingers; handling or feeling objects, tools or controls; close vision; color vision; peripheral vision; ability to adjust focus.
  • Occasional: Standing; walking indoors; reaching with hands and arms; stooping; kneeling; crouching; lifting and/or move up to 10lbs.
  • General: Moderate noise level, similar to typical office environment with computers, printers and light traffic.
  • Some business travel is required.