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Director, ViiV Regulatory Affairs

GSK
Job LocationBrentford
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Site Name: USA - North Carolina - Research Triangle Park, UK - London - BrentfordPosted Date: Jul 16 2020Director, Regulatory Affairs - Viiv Healthcare Location: GSK House, UK or RTP, North Carolina Job PurposeWe have a fantastic opportunity for a talented Global Regulatory Affairs Director with significant regulatory affairs knowledge/experience to join our ViiV Regulatory team in either West London or RTP, North Carolina. This represents an exciting opportunity to be part of ViiV Healthcare, a company 100% dedicated to HIV medicines and research and completely focused on people affected by HIV/AIDS.In this role, you will provide regulatory strategic leadership for the early and late stage ViiV portfolio and will be responsible for ensuring oversight of shareholder/service provider-executed regulatory activities including development, integration and implementation of effective regulatory strategies for ViiV Healthcare assets globally.Strategic partner with ViiV R&D, Medical Affairs and Commercial in delivering and maintaining our ViiV product pipeline, whilst complying with Health Authority regulations.Responsibilities

  • The Global Regulatory Affairs team in ViiV Healthcare are strategic partners with GSK Global Regulatory Affairs function in delivering the global regulatory strategies to deliver our innovative portfolio, whilst complying with Health Authority regulations. We share learnings and best practices across ViiV and GSK to foster continuous improvement across the ViiV portfolio.
  • We operate by building trusting relationships with internal and external partners, including Regulatory Agencies.
  • This role serves as a key partner with the ViiV R&D, Medical Affairs and Commercial teams and works closely and oversees the GSK Regulatory Matrix Team to conceive and deliver innovative regulatory strategies for all ViiV assets from Discovery to late phase development and filing.
  • The Director must be able to integrate aspects of strategic and operational Regulatory Affairs into asset development, collaborating with the cross functional team including Clinical Research, Biostatistics, Nonclinical, CMC, Diagnostics/Device, Commercial, etc.
  • The Director is responsible to proactively counsel teams, and interpret health authority feedback, regulatory precedent, guidelines and policy to drive the medicine strategy, as well as driving or supporting efforts to shape the regulatory environment.
  • The Director may be part of ViiV Medicines Development Teams (MDTs) and ViiV Governance and Oversight committees with responsibility for ensuring the ViiV regulatory position is communicated and implemented.
    • Skills & Experience
  • Minimum 5+ years of global regulatory experience in drug development and life-cycle management.
  • Experience in working globally with strategic partners/cross company collaborations
  • Experience of all phases of the drug development process in Regulatory Affairs; with a preference for recent experience in early drug development.
  • Experience in preparation of Global regulatory submissions (INDs, IMPDs, NDA, MAA, Line Extensions etc.) with strong knowledge and experience in CMC product development and Agency interactions is preferred. Provide insight and guidance on current regulations with respect to regulatory lifecycle activities
  • Prior experience leading health authority interactions; experience leading or supporting major submissions from filing through approval
  • Demonstrated leadership capabilities and ability to think strategically
  • Ability to integrate regulatory science with scientific/clinical knowledge
  • Ability to influence (internal and external) staff at all levels, to achieve an agreed course of action where there are potentially conflicting issues and interests.
  • Ability to negotiate satisfactory solutions with regulatory agency staff as issues arise.
  • Strong written and verbal communications skills
  • Excellent negotiation skills across levels within an organisation and with external stakeholders
  • Able to manage multiple projects and proactively plan
    • NB: The close date for this position is Thursday 30th July 2020 COBAs a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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*(*US only).We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.Please don’t hesitate to contact us if you’d like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on, or send an emailAs you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources depart

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