Regulatory Operations, Global Logistics
Title: Regulatory Affairs Specialist, Submissions - IND/Drug
Contract Length: 03/02/2020 to 09/02/2020
Location: Summit, NJ
- 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.
- 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.
- 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.