We have a fantastic opportunity for a talented Global Regulatory Affairs Director with significant regulatory affairs knowledge/experience to join our ViiV Healthcare Regulatory team in either the UK or Durham, 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 and support for the early and/or late stage VH portfolio and strategic partnership with R&D, Medical Affairs, and Commercial in delivering and maintaining current products and those in the pipeline, whilst complying with Health Authority regulations. You will be responsible for ensuring oversight of shareholder/service provider-executed regulatory activities including development, integration, and implementation of effective regulatory strategies for VH assets globally.
The ViiV Healthcare Regulatory Affairs Team partners with GSK Global Regulatory to develop global regulatory strategies to deliver our innovative portfolio. We are strategic partners with ViiV R&D, Global Medical and Commercial in delivering and maintaining our product pipeline, whilst complying with Health Authority regulations. We share learnings and best practices to foster continuous improvement. We strive to shape the evolving regulatory environment and influence policies/guidelines in areas that are key priorities for ViiV Healthcare.
We operate by fostering strong global teamwork and building trusting relationships with internal and external partners, including Regulatory Agencies. We use our leadership, strategic thinking, smart risk-taking skills, global regulatory acumen, analytical ability, communication and influencing skills to advise our internal partners and negotiate with external stakeholders.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
- Provide support and ensure oversight of shareholders/service provider-executed regulatory activities for ViiV Healthcare assets globally.
- 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.
- 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.
- Active member of Regulatory Matrix Team(s), Development Teams, and ViiV Governance and Oversight committees with responsibility for ensuring the VH regulatory position is communicated and implemented.
- Ensure the ViiV Healthcare Head of Regulatory is fully informed of all key regulatory activities and issues, and when required interact directly with ViiV Healthcare Senior management.
Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
We are looking for professionals with these required skills to achieve our goals:
- 5+ years of global regulatory experience in drug development and life-cycle management.
- Master's Degree in Health Sciences or Regulatory Affairs Discipline.
- Experience in Global (US, EU and International) regulatory affairs.
- Knowledge of regulatory needs of a project from both a regional and global perspective.
- Experience in working globally with strategic partners/cross company collaborations.
- Experience of all phases of the drug development process in Regulatory Affairs.
- Regulatory strategy leadership
- Experience in manage multiple projects simultaneously and proactively plan.
- Experience in integrating regulatory science with scientific/clinical knowledge.
- Experience in working with staff (internal & external) at all levels, to achieve an agreed course of action where there are potentially conflicting issues and interests.
- Experience in negotiating across levels within an organisation and with external stakeholders.
If you have the following characteristics, it would be a plus:
- Experience with device regulations and submissions.
- PhD or PharmD.
- Self-motivated with the ability to work independently, to develop credibility with colleagues within ViiV and GSK
- Ability to resolve problems through resourceful use of information and contacts
- Strong written and verbal communications skills.
- Ability to build effective working relationships.
Why ViiV Healthcare?
Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
We look forward to working with you! #LI-GSK
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ViiV is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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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