Manager, Regulatory Affairs

Job Description

Job Title:             Manager, Regulatory Affairs

Reports To:          Chief Regulatory

Location:               Boston, MA

Position Summary:

Manages, evaluates and completes regulatory projects consistent with the company goals. Responsible for timely planning and coordination of regulatory submissions. Provides guidance to cross-functional teams on regulatory strategy and tactics.

What makes this role special:

  • Seek to have a profound impact on young children and their families
  • Be part of developing a medicine for rare pediatric liver diseases
  • Collaborate with a small, collegial team of good people
  • Work on a portfolio of multiple potential therapies
  • Learn from leadership with deep experience and a history of success
  • Be part of an early biopharma company in an excellent financial position
  • Enjoy great work/life balance, including flex hours, ability to work remotely on Friday’s, generous holiday schedule and business-casual work environment

Responsibilities (may vary):

  • With minimal supervision, plan and manage regulatory activities related to assigned development projects. Assist in developing and implementing strategies for the earliest possible approvals of regulatory submissions associated with assigned development projects
  • Manage the assembly and timely submission of INDs, NDAs, MAAs and other dossiers as required for investigation and registration of Albireo products in the US and abroad
  • Ensure regulatory submissions are maintained in compliance with regulatory requirements
  • Represent the company in its dealings with the FDA and other regulatory authorities as appropriate
  • Participate on project teams and provide expertise on regulatory matters
  • Develop and maintain current regulatory knowledge and advise management of significant developments
  • Manage and develop regulatory staff as appropriate

Key Duties and Responsibilities:

  • With minimal supervision, plan and manage regulatory activities related to assigned development projects. Assist in developing and implementing strategies for the earliest possible approvals of regulatory submissions associated with assigned development projects
  • Manage the assembly and timely submission of INDs, NDAs, MAAs and other dossiers as required for investigation and registration of Albireo products in the US and abroad
  • Ensure regulatory submissions are maintained in compliance with regulatory requirements
  • Represent the company in its dealings with the FDA and other regulatory authorities as appropriate
  • Participate on project teams and provide expertise on regulatory matters
  • Develop and maintain current regulatory knowledge and advise management of significant developments
  • Manage and develop regulatory staff as appropriate

Qualifications:

  • Bachelor’s degree or higher
  • 6-8 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry
  • Experience and knowledge in preparation of INDs, NDAs, and supportive amendments and supplements. Experience with CTD/eCTD mandatory
  • Working knowledge of FDA and ICH regulatory guidance and regulations. Understanding of FDA structure and function
  • Experience with EU submissions is a plus
  • Working knowledge of GMP, GLP and GCP regulations as well an understanding of the pharmaceutical product life cycle
  • Working knowledge of regulations related to drug development
  • Outstanding written and verbal communication skills

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.