Director, Regulatory Affairs US Vaccines

Basic qualifications:

Masters degree

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

Preferred qualifications:

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

  • LI-GSK

Contact information:

You may apply for this position online by selecting the Apply now button.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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