Director, ViiV Regulatory Affairs

ViiV Healthcare is the only company solely dedicated to the discovery, clinical development and commercialization of medicines for people living with HIV or for people who can benefit from HIV prevention. With a broad range of transformational, industry-leading medicines and a deep pipeline including cure, ViiV is well-positioned for growth over the next decade. We are ambitious for patients, highly accountable for impact, always doing the right thing.

Are you looking for an opportunity to be the leader that passionately catalyses and elevates the mission of leaving no person living with HIV behind? Of making HIV a smaller part of people's lives?

We 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 London, 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 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 products globally.

Key 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 to foster continuous improvement across the portfolio. We strive to shape the evolving regulatory environment and influence policies/guidelines in areas that are key priorities for GSK and ViiV Healthcare.

• This role serves as a key strategic 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 product 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 will be part of ViiV Medicines and Early Development Teams and with responsibility for ensuring the VH regulatory position is communicated and implemented.

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Strong 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 CMC regulatory submissions (INDs, IMPDs, NDA and/or MAA) with strong knowledge and experience in CMC product development and Agency interactions is preferred. Provide insight and guidance on current regulations with respect to CMC regulatory lifecycle activities.

• Prior experience leading health authority interactions; experience leading or supporting major submissions from filing through approval

• Experience managing multiple projects and proactive planning

• Master's Degree or Higher(ideally Science/Regulatory Affairs)

Other Skills/Experience:

• Demonstrated leadership capabilities and ability to think strategically

• 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.

• Strong written and verbal communications skills

• Excellent negotiation skills across levels within an organisation and with external stakeholders

• Ability to integrate regulatory science with scientific/clinical knowledge

• Ability to negotiate satisfactory solutions with regulatory agency staff as issues arise.

Please apply via our online portal providing your CV and Cover Letter.
(Please take a personal copy of the Job Description, as this will not be available online post closure of the advert)

Closing Date: COP 17th April 2025

Hybrid working applies to this role, with ViiV expectation of 2-3 days per week onsite at HQ London, UK or Durham, US.

#Hybrid

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpageLife at GSK | GSK

Why Us?

At ViiV Healthcare, we will not rest until we leave no person living with HIV behind. Until the 39 million people living with HIV is down to zero, we will continue searching for new ways to limit the impact of HIV.

We are the only pharmaceutical company solely focused on combating, preventing, and ultimately eradicating HIV and AIDS. At ViiV Healthcare, we do things differently. Born out of a partnership between GSK and Pfizer in 2009, with Shionogi joining in 2012, we are determined to help end the HIV epidemic. We are guided by our mission to leave no person living with HIV behind and it is this mission that unites our employees located across the globe. We combine expertise in research, manufacturing, policy and more to push the boundaries of what people think is possible in HIV treatment and care. As a result of our connection with GSK, we are able to draw on their proud history and resources. This means that you would receive all the employee benefits offered by GSK.

Living our mission of leaving no person living with HIV behind means keeping inclusion and diversity at the heart of everything we do - from our breakthrough innovation, to our diverse portfolio of medicines as well as the work we do to partner with HIV communities. Having a diverse team and a truly inclusive culture where we're all able to be ourselves and feel like we belong will make us an even stronger team, better able to perform as a business and deliver on our mission to leave no person living with HIV behind.

ViiV 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.

Important notice to Employment businesses/ Agencies

ViiV 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 ViiV's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to ViiV. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and ViiV. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of ViiV. ViiV shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, ViiV may be required to capture and report expenses ViiV incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure ViiV's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/