Global Regulatory Manager

GLOBAL REGULATORY MANAGER LAWRENCE TOWNSHIP, NJ Required Skills:

• Solid scientific background (BS, MS, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine or veterinary).
• 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.
• Strong team player with ability to seamlessly collaborate across functional and geographic boundaries to achieve company's goals .

• 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:
  • IND, BLA, and NDA maintenance submissions .
  • Safety and Annual report submissions (regulatory components) .
  • 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.
  • Maintaining global submission plans and supporting those plans can be executed on time .
  • 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 .