Associate Director, International CMC Regulatory Affairs – Established Products Team Leader

Job title:

Associate Director, International CMC Regulatory Affairs – Established Products Team Leader

Company

Gilead

Job description

For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.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.We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.Job DescriptionKEY RESPONSIBILITIESThe Established Products Team Leader, CMC Regulatory Affairs International, manages and coaches a team of professionals responsible for registration of Gilead’s commercial portfolio of established products in global markets. This is a new team developed to support Gilead’s growing established products portfolio and will be an integral function in the CMC regulatory affairs organization which is part of the broader Pharmaceutical Development & Manufacturing (PDM) organization. This position will lead a team that provides Gilead the “right to operate” by maintaining and renewing commercial licensures. The core work of the team may be managed using a managed service model using supporting personnel located either internally or externally. The role will report directly to the Head of CMC Regulatory Affairs, International based in Cambridge, UK.JOB DESCRIPTION

• Build and lead a team to support the maintenance and renewal of established commercial products in global markets.
• Develop ways of working for the newly created team and build relationships with departments outside of CMC RA to define filing strategy and plans.

• Responsible for preparation of the Quality sections for post-approval variations, renewals, and responses to agency questions, for all established commercial products in global markets. Ensure dossiers meet ICH and local regulatory requirements.
• Partner with PDM to manage life-cycle maintenance aspects of established product CMC submissions.
• Act as the CMC RA representative for established products, within a global matrix team, contributing to global CMC regulatory strategies for all markets.
• Responsible for ensuring timely discussion with international health authorities regarding responses to questions and work with global CMC RA colleagues to ensure consistency of responses.
• Lead the execution of the international market CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, Gilead local country affiliates and third-party agents, and Project Management.
• Co-ordinate regulatory assessments for post-approval CMC changes, developing filing plans for impacted markets and execute filings according to agreed priorities.
• Ensure regulatory conformance and consistency for established products in the international markets in compliance with regulatory requirements and internal procedures.
• Identifies improvement opportunities for CMC regulatory processes, policies, and systems. May contribute to process improvement.
• Work (matrix) with the CMC RA Policy Office to proactively build/maintain contacts with local Health Authorities, and to present a positive image of Gilead in all discussions with Health Authorities.
• Maintain a current awareness of CMC registration requirements in each of the international regions and communicate key regulatory intelligence to the organization on a timely basis.
• Act as a liaison for other groups across CMC RA to identify opportunities with external service providers to resource other global CMC RA activities.
• Demonstrate and model Gilead’s Core Values, Leadership Commitments, and People Leader Accountabilities; Embrace and comply with global CMC principles of integrity.

QUALIFICATIONS

• A scientific degree with directly relevant professional experience in small molecule and/or biologics registrations, global CMC regulatory affairs, and CMC technical areas with a BA/BS or 8 years with an MA/MS, PhD, PharmD, or MD.
• Experience in the preparation of CMC components for post-approval variation submissions for small molecule and/or biologics products.
• A proven ability to co-ordinate the preparation of a variety of CMC regulatory documents in collaboration with other functions.
• Demonstrated success in influencing without positional authority within a highly matrixed organization.
• Experience working with external vendors to support internal/external/off-shoring resource options is desirable.
• An in-depth knowledge of ICH requirements, and an understanding of current global and regional trends in CMC Regulatory Affairs.
• Application of sound and accurate judgment to make timely decisions.
• Experience representing CMC regulatory affairs on regulatory and cross functional teams.
• Established strategic, collaboration, and communication skills are required.
• Demonstrated commitment to inclusion, developing talent and empowering teams.

Gilead Core Values

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

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.

Expected salary

Location

Cambridge

Job date

Sat, 08 Mar 2025 23:58:22 GMT

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