Senior Manager/Associate Director, Regulatory Affairs

2 weeks ago

Watertown, United States People With Chemistry Full time

Meet is working with a dynamic and innovative biopharmaceutical company dedicated to advancing Neuroscience therapies through cutting-edge research and development. They have a focus on improving patient outcomes, and are at the forefront of clinical trials that push the boundaries of medical science.

They are actively hiring a Senior Manager/Associate Director, Regulatory Affairs to act as the regulatory lead on multidisciplinary projects and clinical study teams, to provide input on documentation and procedural requirements defined by regulatory authorities. This will include submission delivery strategy, reviewing documents, and the analysis of procedures that are used during development.

You will also be responsible for the following;
- Creating, reviewing, and contributing, and editing submissions to support development including US Investigational New Drug (IND) submissions, Canadian and EU Clinical Trial Applications (CTAs).
- Ensuring appropriate planning, tracking, and alignment of content and timelines for regulatory submissions across indications and compounds.
- Travel occasionally for meetings and conferences.
- Keep up to date with regulations and guidance, interpret and notify appropriate colleagues and stakeholders.

Qualifications:
- 10+ years of experience in Regulatory Affairs in a Pharmaceutical company, Biotech, Biopharma, or CRO.
- PhD, Masters Degree or Bachelor's of Science
- Demonstrated track record of successful clinical trial submissions in Canada, US, and Europe required.
- Demonstrated, hands-on experience, managing and preparing regulatory submissions especially Clinical Trial Applications outside of North America with a primary focus on European applications through the Clinical Trials Information System (CTIS)
- Extensive knowledge in Phase III - ability to help manage all activities in Phase III

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