Regulatory Affairs Manager

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Job description

Responsibilities:

Support multiple Global Regulatory project teams and key sub-teams; provide functional expertise to GRLs and matrix early development teams.

Collaborate with Client regional and country regulatory affiliates to support ex-US clinical development activities.

Provide support to prepare for presentations of Regulatory strategies and issues at team or governance meetings.

Serve as primary Health Authority contact for assigned projects and foster positive and effective working relationships between project team members and regulatory authority reviewers.

Assist in preparing teams and materials for FDA (or other regulatory authority) meetings.

Participate in or lead the creation, review, assembly and submission of regulatory documentation including clinical trial applications and amendments to these regulatory files, as appropriate.

Ensure consistency/completeness/adherence to standards for all regulatory submissions.

Coordinate and consult with other departments on the content, review of publication materials, and assembly of regulatory documentation.

Support or lead non-program specific projects as assigned such as department initiatives, business development assessments, clinical assessments, and department training, etc.

Requirements:

Bachelor's degree or equivalent required in related discipline.

5 + years of experience in biotechnology or pharmaceutical industry, including R&D/related disciplines.

5 years of experience in Regulatory Affairs within biotechnology/pharmaceutical industry.

Demonstrated understanding of regulations and guidelines governing drug development; has relevant knowledge and experience in applying these to strategic drug development.

Perceived as a subject matter expert by internal colleagues.

Effective interfacing with regulators; has experience working with Health Authorities.

Works effectively in complex, matrix organizations; drives outcomes and recommendations for action/consideration.

Strong written and verbal communication skills.

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