Back to Job Search

Global Regulatory Manager - Remote

  • Location: Lawrenceville
  • Job Type:Contract

Posted 19 days ago

  • Expiry Date: 09 December 2022
  • Referral: 219533@accuick.com

Job Description:

Responsibilities:

  • 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.

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.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

Contact:

Full Name: Akash Mehra

Email ID: akashm@askconsulting.com

Phone: 908-224-9613