Director, Regulatory Affairs US Vaccines
10+ years significant experience in regulatory affairs, or appropriate relevant experience
- Experience in managing teams, across countries if possible
- Knowledge and expertise in CMC, NC, Clinical, labeling and procedural aspects (at minimum two of these areas)
- Deep experience with US regulatory environment
Ph.D. or M.D
Pharmacy, Chemistry, Biology or Medicine
- Ability to identify and escalate issues and to propose mitigation strategies, maximize opportunities, with proven ability to develop collaborative relationships and have high impact and influence
- Good presentation skills to ensure that GSK Vaccines regulatory voice is clearly articulated and heard in the various cross functional teams
- Support the US-based staff in providing regulatory input to other GSK divisions in line with GRL team position or to regulatory agencies, as appropriate.
- Good influencing skills.
- Good coaching skills
- Good mentoring skills
- People management abilities and focus on personal development of US based individuals
- Culturally aware.
- Ability to think World-wide and include in a balanced way the US specificity early on in the regulatory strategies established within the portfolio.
- Ability to collaborate with other departments and teams in the delivery of outputs in a timely manner
- Ability to resolve problems through resourceful use of information and contacts.
- Enterprise thinking – needs to understand the constraints and drivers of other functions and the potential impact on RA World-wide, including how RA may facilitate in achieving the overall goal.
- Quality mindset
- Fluent in English, with excellent writing skills.
- Able to input into the Company’s regulatory positioning, and write /critically review key documents targeting internal or external key audiences
- Ensure that documents intended for US regulatory submissions are in line with US regulations
Regulatory US Group Lead, Vaccine
Position holder (PH) will have the following responsibilities within a specific GRA project/portfolio within GSK Vaccines:
- Managerial responsibilities for US-based staff within a specific portfolio, including resources overview and optimization at US GRA level, advice for US specific activities/processes, ensure appropriate training of US-based staff, and issue escalation
- Cross portfolio aligned regulatory strategy to assure timely approvals for all US submissions.
- Attend Head RA RDC staff meeting or RDC product strategy meetings and other relevant meetings as appropriate in agreement with RA RDC Head and NARA Head.
- 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:
- 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
- Organization of back-ups across group
- 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
You may apply for this position online by selecting the Apply now button.
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