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Regulatory Affairs Liaisons Manager- Global Therapeutic Area (TA), Uxbridge
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Client:
Gilead Sciences International, Ltd.
Location:
Uxbridge, United Kingdom
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
304552453fbd
Job Views:
3
Posted:
29.06.2025
Expiry Date:
13.08.2025
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Job Description:
Description
POSITION OVERVIEW:
The global regulatory affairs team is responsible for supporting Gilead to make sound strategic decisions to enable access for patients to our molecules.
The position is in the Virology IC/GPS regulatory franchise which is responsible for Intercontinental and Gilead Patient Solutions, working across territories throughout Asia, Latin America, Africa, Eastern Europe and the Middle East.
Working within the global team, you will support defining the regulatory strategy, plans and objectives for assigned products or projects. Your responsibilities will involve managing regulatory submissions and other projects, representing the IC/GPS regulatory franchise on cross-functional core and sub-teams.
As a Regional Regulatory Lead of products in the virology therapeutic area you will typically be assigned multiple products or projects to lead, manage and oversee simultaneously.
You will provide strategic and technical advice from development throughout the whole product lifecycle for all HIV, Hepatitis and Emerging Viruses projects/products.
Activities will include preparing and maintaining regulatory submissions, regulatory labelling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities.
You will work cross-functionally with a diverse number of stakeholders both internally and externally to Gilead.
EXAMPLE RESPONSIBILITIES:
Managing and leading regulatory strategies for designated products in the region. This ranges from new product licenses to lifecycle activities and includes oversight of all regulatory aspects of the application.
Preparation of regulatory submissions for products in the virology therapeutic area and execution of agreed strategies within the region.
Partner both within regulatory affairs and throughout the development and commercial organization. Collaborate with cross-functional partners to ensure optimal execution of the agreed regulatory strategy.
Establish strong relationships with Gilead affiliates and distributor partners and serve as point person for knowledge for their product to these key stakeholders.
Have a good understanding of the regulatory environment leveraging internal knowledge and external regulatory intelligence.
Preparation and maintenance of labelling to support MAAs and other post-licensing activities. Ensure that any updates to the Product Company Core Data Sheet (CCDS) are implemented in a timely manner.
Liaise with regulatory, manufacturing, and other parties as appropriate, to ensure that updates to the product packaging components are implemented in line with approved labelling in line with agreed timelines.
Participate and contribute to regulatory team meetings and be recognized as a knowledgeable resource for Regulatory Affairs in other departments.
May participate and lead collaborative efforts across function in process improvement initiatives.
Use internal electronic systems for planning, preparing, tracking and storing submissions to regulatory agencies.
REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Education & Experience
BA/BS or advanced degree in life sciences or related field with regulatory experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Experience a broad range of regulatory activities and setting the regulatory strategy for biopharmaceutical products.
Knowledge & Other Requirements
A good working regulatory knowledge, including ICH and regional requirements.
An appreciation of current global and regional trends in Regulatory Affairs with proven effectiveness in applying this knowledge to optimize team deliverables.
Previous experience of working with emerging markets and/or in the Virology therapeutic area would be an advantage but not essential.
Methodical attention to detail.
Must have a “can do” attitude and be “hands on” as and when required.
Proven track record to manage, formulate and execute strategy.
Strong interpersonal skills and understanding of team dynamics.
Strong communication and organizational skills.
Strong negotiation and conflict resolution skills.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
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