Senior Consultant at Freelancing
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Director - Cross Program Group Lead - Regulatory Affairs - US Vaccines (15-25 yrs)
Director, Cross-Program Group Lead, Regulatory Affairs US Vaccines
- North America Regulatory Affairs (NARA) is a dynamic and growing part of COMPANY Vaccines' Global Regulatory Affairs Organization. The Rockville, MD-based group of regulatory experts focuses on COMPANY's U.S.-licensed and developing-vaccine pipeline and provides advice on U.S. regulatory strategy for cutting-edge, novel vaccine technology while also delivering on post-marketing reporting requirements, regulatory filings in support of new applications, and liaising with the U.S. FDA and global product leads. The group's leadership team members have diverse scientific backgrounds in virology, pharmacology, biochemistry, chemistry, and molecular biology, with decades of combined experience in drug development and vaccines.
The Role :
As a US Cross-Program Group Lead, within North America Regulatory Affairs, you will be responsible for regulatory submissions, interactions, and strategy related to products within the US. The role provides US-focused strategic advice and executes on deliverable for US submissions and FDA interactions. The function has reporting requirements to the VP and Head of NARA and includes people and project/portfolio management bench-marked to key performance indicators aligned with the department and global objectives. Role will be part of the NARA leadership team (NARA LT) and share responsibility for overall US regulatory strategy and operations.
As a US Cross-Program Group Lead, Global Regulatory Affairs you will have the following responsibilities within a specific GRA project/portfolio within COMPANY Vaccines:
- Cross portfolio aligned regulatory strategy to assure timely approvals for all US submissions.
- Facilitate integration of US-based individuals within portfolio group and integration of US-specific regulatory aspects into projects in general within the portfolio
- Ensure US-specific regulatory learnings are shared with the rest of the team, in line with culture of coaching
- Managerial responsibilities for US-based individuals within a specific GRA project/portfolio, consisting of resources overview and optimization at US GRA level, advice for US specific activities/processes, ensure appropriate training of US-based staff, and issue escalation:
- Management of US based staff within Portfolio
- Resources overview and optimisation of work distribution within Product/Project teams in agreement with GRL/RA RDC Head/NARA Head
- Cross portfolio resources support as appropriate
- Provide advice on US-specific activities and ways of working, processes as mentor or coach; in this role, provide support, as needed, for meetings/teleconferences with US regulatory agency, if deemed appropriate in discussion with US-based individual in charge of the project and the respective GRL or RDC personnel.
- Escalate issues as appropriate
- Ensure the training of US-based personnel, and ensure completeness of training curriculum, in compliance with CIA
- Project-specific responsibilities :
- May be involved in review of US submissions, upon request of the Global Regulatory Lead (GRL) or NARA Head, to ensure adequacy/optimization of US-specific aspects within a submission.
- In their direct line to Head North America, the job holder will ensure:
- That regional strategic input is provided into RA project strategy and escalation as appropriate - i.e. ensure alignment and sharing of information/strategy across region and central GRA
- Attendance to NARA staff meeting
- Ensure alignment and adequate support of US Reg Ops
- Quality and process improvement within US
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