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Director, Regulatory Affairs

Company: WAVE Life Sciences
Location: Lexington
Posted on: June 19, 2019

Job Description:



Director, Regulatory Affairs



Location



Lexington, MA




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Responsibilities:

-Ensure development of robust, global regulatory strategies for assigned projects and be accountable for adapting and/or maintaining the regulatory strategy as needed.

-Provide ongoing regulatory guidance to project teams.

-Interact directly with FDA and other health authorities and ensure that interactions with regulators are properly communicated to the development team.

-Develop submission plans and timelines in accordance with project goals. Lead cross-functional efforts to deliver high quality submissions, e.g., INDs, CTA, orphan applications. Ensuring that Manager is aware of any major issues with the project, including any changes to plan or risks.

-Manage submission development. Develop and/or author content as applicable. Direct subject matter experts in content development and authoring.

-Triage and coordinate responses to questions from regulatory authorities.

- Contribute to initiatives to improve processes within the Regulatory department.

-Keep abreast of regulatory guidance and technical/scientific developments relevant to projects. Contribute to commenting on draft regulations and assess future areas for influencing the regulatory environment.

Qualifications/Skill Set:


  • BA/BS degree in life sciences, MS preferred

  • At least 5-10 years of pharmaceutical product development, preferably in neurology

  • Well-versed in regulatory strategy, and regulatory writing

  • Experience as primary regulatory author for IND and CTA documents

  • Knowledgeable in ICH, FDA and EMA guidelines

  • Knowledge of eCTD structure

  • Ability to work independently and thrive in a fast-paced environment

  • Attention to detail

  • Excellent communication skills

  • Ability to think creatively

  • Team player with the ability to be a situational leader when required



Keywords: WAVE Life Sciences, Leominster , Director, Regulatory Affairs, Executive , Lexington, Massachusetts

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