Regulatory Operations, Global Logistics

Location: Summit, New Jersey, United States
Salary: competitive
Job Type: Contract
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Title: Regulatory Affairs Specialist, Submissions - IND/Drug

Contract Length: 03/02/2020 to 09/02/2020

Location: Summit, NJ

Responsibilities

  • In conjunction with Regulatory Leads, coordinate creation and approval of global regulatory plans, and transmit to internal and external experts to execute the plan
  • Coordinate internal alignment and approval of global submission plans; ensure those plans can be executed with internal and external resources on time
  • Manage, track, review regulatory deliverables from external partners in line with vendor manager
  • Maintain regulatory work schedules with vendors and vendor managers for assigned project using common data-points and milestones
  • Coordinate GRS support for HA interactions lead by regional / local liaisons
  • Support Regulatory Lead in the preparation of HA interactions (meeting preparation, rehearsals, execution, follow-up, minutes, etc.)
  • Provide support for tracking progress and resolving issues with CTA preparations and submissions and approvals
  • Facilitate the regulatory dossier submissions to HA (IND, CTA, BLA, NDA, etc.) utilizing internal and external resources; ensure appropriate quality controls in place for compliant submissions
  • Coordinate preparation of response to HA questions according to a rapid response process for assigned projects
  • Maintain tracking data in PMC and PMR database
  • Coordinate regulatory communications required for regulatory actions to regional and local regulatory
  • Writing, reviewing signing and submission of maintenance regulatory documents for all IND/CTAs - All within group with consultation of the USRL, EUL or GRL as needed
  • Annual Reporting Responsibilities for regulatory owned components
  • Support submission of US BLA/NDA submissions, as assigned.

Qualifications/Requirements:

  • 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 cooperate and partner with external vendors
  • 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.
  • Potential development into Global Strategy function, US Liaison or other role in Regulatory Sciences.

Other Qualifications:

  • Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional and geographic boundaries to achieve company goals.
  • Detail oriented
  • Communicates opinions, facts and thoughts with clarity, transparency and honesty
  • Demonstrates ownership of results within (and beyond) area of responsibility.
  • Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
  • Looks for opportunities for continuous improvement

Sthree US is acting as an Employment Business in relation to this vacancy.

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