Regulatory Affairs Manager - Katalyst Healthcares & Life Sciences
Austin, TX 73301
About the Job
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.
- 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.
Source : Katalyst Healthcares & Life Sciences
