Senior Manager, Regulatory Affairs

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Senior Manager, Regulatory Affairs – UK and Ireland Apply locations United Kingdom - London time type Full time posted on Posted 6 Days Ago job requisition id R For Current Gilead Employees and Contractors:

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At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

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Job Description

Senior Manager, Regulatory Affairs – UK and Ireland

Holborn

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops, and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer, inflammation, cell therapy, and serious respiratory and cardiovascular conditions. For more information, please visit

We currently have an exciting opportunity for a Senior Manager based in the UK Affiliate at Gilead in High Holborn focussed on Virology.

An affiliate Regulatory Affairs role, the Senior Regulatory Affairs Managerr will assist in the local coordination and execution of regulatory submissions in compliance with Gilead's corporate standards and national regulatory requirements, and of Regulatory Affairs processes and deliverables for the UK and Ireland .

Reporting to the Virology & Inflammation Lead for UK and Ireland , the core elements of this pivotal role will include supporting local execution of the Global regulatory filing strategy, including initial MAA's, post-MA activities and clinical trial application (CTA) submissions, in alignment with the UK and Ireland commercial strategy, with a focus on Virology.

Specific Job Requirements

• May include line management for 1-2 staff
• Expert on regulatory environment and intelligence within the UK and Ireland and contributes to preparation of new local regulatory guidance documents when applicable
• Responsible for coordination with multiple stakeholders' national submissions and management of initial Marketing Authorisation (MA) applications, PIP's, ODD's and managing post-approval submissions such as Variations, PSUR's, RMP updates, amongst other MA maintenance applications
• Timely and compliant filing of clinical trial applications, amendments, and other clinical trials submissions
• Establishes and maintains good and strong relationships with all functional areas of the local organisation (Medical Affairs, Commercial, Market Access, Legal, etc) and with Gilead Sciences Global RA to ensure the success of local and international business results from the regulatory point of view
• Reviewer for promotional and non-promotional activities and materials and ensuring their compliance with local guidance, codes of conduct and Gilead SOPs
• Local GxP compliance expert assisting with and where appropriate leading the local regulatory activities, including internal and agency lead inspections and audits, SOP development, gap analysis and subsequent process improvement initiatives
• Lead process improvement initiatives and subsequent procedural document development
• Provide regulatory expertise for local business initiatives including market access, business compliance and medical led projects
• Responsible for ensuring product packaging and associated information is updated and maintained in accordance with product SmPCs
• Develop expertise in assign Therapeutic Area, and become Subject Matter Expert (SME) for assigned core Regulatory activities

Knowledge, Experience & Skills

• Requires a solid and proven level of experience in Regulatory Affairs, in an affiliate or global role, or other relevant industry experience
• Science degree/Masters and relevant experience in Regulatory Affairs
• Knowledge and awareness of UK/IE regulatory guidelines and legislation, with good working knowledge of the impact of Brexit
• Highly experienced in filing national variations with MHRA, ideally with an interest or experience in eCTD, publishing, and use of electronic portals
• Experience in management of CTAs including amendments and other CT related submissions
• Experience in GxP compliance
• Experience in review of promotional and non-promotional material in accordance with the UK and Irish industry codes of practice would be advantageous
• Expert project management and time management
• Excellent organisation skills and interpersonal skills
• Excellent verbal and written communication skills in English
• Is recognised as a knowledgeable resource within the department on a range of regulatory topics
• Able to work equally well as part of a team or independently

Behaviours, Capabilities

• Strong teamwork and facilitation – effective at being a member of teams. Listens actively and responds constructively to needs and views of others
• Delivery – gets the job done. Meets or exceeds expectations and exhibits a sense of urgency on critical time-dependant issues
• Demonstrates the ability to prioritise and work autonomously
• Persists despite obstacles and opposition
• Driven – self-drive to identify, initiate and implement projects and processes to address issues

Gilead Core Values

• Integrity (Doing What's Right)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)
• Inclusion (Encouraging Diversity)

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 log onto your Internal Career Site to apply for this job.

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