Summary
- Support Regulatory Lead in the preparation of HA interactions (meeting preparation, rehearsals, execution, follow-up, minutes, etc.)
- Maintain tracking data for health authority meetings, PMRs / PMCs, and other key regulatory milestones and liaise cross-functionally to generate periodic internal milestone reports
- Provide operational support on strategic regulatory documents to help drive timely deliverables
- Drive operational excellence in Global Regulatory Strategy & Policy through projects aimed to support collaboration and improve efficiency
- Additional responsibilities, in conjunction with regional and / or global regulatory leads, include :
o IND, BLA, and NDA maintenance submissions
o Safety and Annual report submissions (regulatory components)
o Coordinating and driving rapid response team meetings to ensure quality and timely responses to health authority queries.
This includes the preparation of response to HA queries according to the rapid response process.
o Maintaining global submission plans and supporting those plans can be executed on time
o Coordinating and driving global regulatory subteam meetings to ensure high quality meeting discussions & outputs; this includes diligent follow-up with Subteam members to uphold accountabilities and drive decision-making
Qualifications / Requirements :
Solid scientific background (BS, MS, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine or veterinary).
Some exposure in the field of neuroscience would be beneficial.
- 1-3 years of pharmaceutical industry experience. Ideally 1 year in regulatory affairs or 2-3 years in a complementary functional area (eg, clinical research)
- Working knowledge of regulatory procedures (US or other)
- Demonstrates a high-level of self-motivation and professional commitment. Indirect management experience of people or major projects.
- Ability to rapidly adapt to different issues and projects at one time. Good interpersonal skills.
- Excellent communication skills.
- Comprehensive understanding of the pharmaceutical industry.
- Comfortable working in a fast-paced environment where speed is paramount
- Willing to work as a topic expert, outside of a traditional functional environment, in a team unified around serving the assets
- Ability to recognize, articulate, and accept calculated risks to make informed decisions
- Willingness and ability to effectively work in a highly matrixed team environment
- Develop understanding of different TAs due to assignment to different projects.
- Increased understanding of the regulatory procedures (US, EU, others) and regulatory landscape.
- Increased exposure to global and multi-functional teams.
Other Qualifications :
- Strong team player with ability to seamlessly collaborate across functional and geographic boundaries to achieve company’s goals
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