Senior Director of Regulatory Affairs

Job Description

Job Title:             Senior Director, Regulatory Affairs

Reports To:          Chief Regulatory Officer

Location:               Boston, MA

Position Summary:

Working in a team environment, the Director will provide regulatory oversight, support and guidance for all company functions, provide key input to regulatory strategy for products in development, and be responsible for planning and coordinating regulatory submissions necessary to support clinical trials and product registration in the United States. The Director will serve as a principal regulatory affairs liaison to FDA and will also be responsible for advising executive management and other staff on the impact of new regulatory authority initiatives and changing regulations as they pertain to the company’s research and development programs.

Essential Functions

  • Create and execute regulatory development plans and manage timelines to achieve the stated goals.
  • Interface directly with governmental personnel, including scientific reviewers, administrative support and management to facilitate the review and approval of regulatory applications.
  • Work closely with clinical and manufacturing departments and across project teams to ensure that all activities are conducted in compliance with relevant laws, regulations, and guidance. Ensure clear communication of project activities and progress in a timely manner.
  • Coordinate the preparation and submission of required documents to regulatory agencies. Ensure submissions are complete, properly formatted, and comply with applicable regulatory requirements.
  • Make certain that appropriate documentation is maintained to record regulatory decisions for company projects.
  • Develop and maintain strong and effective relations with internal/external personnel.
  • Develop and implement innovative regulatory strategies for development projects.
  • Manage the planning and coordination of productive and effective regulatory submissions and regulatory agency meetings.
  • Monitor and analyze regulatory agency activities and advise senior management on appropriate action.
  • Provide leadership on teams and committees in all areas of regulatory affairs.
  • Build and maintain excellent relationships with regulatory authorities.

Qualifications:

  • Minimum BS in life sciences field.
  • 8-12 years experience in regulatory affairs in various stages of product development.
  • Experience in various types of interactions with FDA.
  • Experience and knowledge in preparation of INDs, BLAs, NDAs, and supportive amendments and supplements. Experience with CTD/eCTD.
  • Working knowledge of FDA and ICH published regulatory guidance and regulations. Understanding of FDA structure and function.
  • Must have knowledge of GMP, GLP and GCP regulations as well an understanding of the pharmaceutical product life cycle.
  • Expert knowledge of regulations and guidelines related to drug development.
  • Strong negotiation, communication and interpersonal skills and ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.

JOIN ALBIREO

Equal Opportunity Employer

Albireo Pharma, Inc. is an equal opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

All applicants should be legally entitled to work for any employer in the U.S.

Note to employment agencies: Please do not forward any agency resumes.  Albireo is not responsible for any fees related to resumes that are unsolicited.