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AD, Regulatory Affairs (8A-44)

Expired Job

Akebia Therapeutics, Inc. Cambridge , MA 02138

Posted 2 weeks ago

Akebia is currently expanding its Regulatory team to support late phase clinical assets and is searching for an Associate Director, Regulatory Affairs. This individual will operate in a high visibility role and will be responsible for representing Regulatory Affairs in cross-disciplinary project teams, developing regulatory strategies for assigned program(s), and manage high-quality submissions to regulatory agencies through external consultants. As Akebia develops clinical assets there could be additional duties and responsibilities to this role, including the expansion and management of additional team members. This position reports to the Sr Director, Regulatory Affairs.

Required Skills

  • Propose and design well-informed regulatory strategies for the US and EU

  • Represent Regulatory Affairs on project sub-teams, especially Clinical and Nonclinical, and provide regulatory guidance to project teams (e.g. protocol reviews, report reviews, development plans)

  • Assist in the preparation for regulatory agency meetings (e.g. pre-IND, End-of-Phase 2, Type C, pre-NDA/MAA/NDS)

  • Lead the preparation of regulatory submissions including INDs, CTAs, annual reports, NDAs, MAAs, briefing packages

  • Write regulatory documents to support regulatory submissions

  • Coordinate with external publishing resources for on-time delivery of high-quality regulatory submissions to regulatory agencies

  • Coordinate with selected regulatory CROs for submission of high-quality documents to support ex-US submissions

  • Establish and maintain ClinicalTrials.gov postings for supported studies

  • Establish relevant processes and procedures to support activities of the Regulatory Affairs function

  • Participate in regulatory intelligence gathering activities and maintain knowledge of US and EU regulatory requirements

  • Ensure compliance with regulatory requirements

Required Experience

  • Bachelor's degree in life sciences required; advanced degree preferred

  • Minimum of 8 years of pharmaceutical industry experience with a minimum of 5 years in Regulatory Affairs

  • Evidence of successful submissions to FDA (e.g., INDs, briefing packages)

  • Demonstrated evidence of writing of regulatory documents (e.g., Module 1, Module 2, briefing packages, orphan drug designation applications, pediatric plans)

  • Knowledge of FDA and ICH regulations and guidelines a must

  • Knowledge of EU regulations and guidelines desirable

  • Knowledge of drug development

  • Excellent written and oral communication skills

  • Excellent interpersonal skills

  • Strong project management skills and drive for excellence

Job Location Cambridge, Massachusetts, United StatesPosition TypeFull-Time/Regular

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AD, Regulatory Affairs (8A-44)

Expired Job

Akebia Therapeutics, Inc.