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Gilead

Senior Regulatory Affairs Associate, CMC ROW

For Current Gilead Employees and Contractors:

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

Job Description

Senior Associate, Regulatory Affairs CMC (ROW)

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 Gilead.com

We currently have an exciting opportunity for a Global CMC Senior Regulatory Affairs Associate based in Gilead’s Cambridge office.

Specific Responsibilities: 

Based in Gilead’s Cambridge office, this exciting position within the Global CMC Regulatory Affairs organisation will be based within a small team delivering the CMC Quality components for clinical trial applications, new licence applications and post approval submissions in International “Rest of World” territories including Asia, Latin America, Middle East, Eastern Europe and Africa.  Working alongside the Pharmaceutical Development and Manufacturing team, International Regulatory teams and local affiliates/distributors the successful candidate will be integral in the strategy and submission of CMC components for ROW markets.

This new opportunity will offer you the chance to grow your Regulatory Affairs expertise across a wide range of territories with diverse regulatory requirements and processes and an evolving regulatory landscape.  

Essential Functions:

Prepare the Quality sections of INDs/IMPDs, new MAAs, CMC variations and renewals for submission in Rest of World (RoW) territories. Ensure that dossiers meet ICH and local regulatory requirements.

Co-ordinate the preparation of responses to CMC questions from regulatory authorities.

Work with pharmaceutical development, manufacturing, QA and external partners to deliver CMC Quality components for regulatory submissions in ROW territories in accordance with corporate objectives or post-licensing commitments.

Liaise with Gilead’s local Affiliates, distributors or agents to define/clarify CMC submission requirements.

Provide advice to pharmaceutical development and manufacturing colleagues on RoW regulatory requirements for new submissions and for post approval change management.

Maintain an up to date awareness of CMC regulatory requirements for applicable territories and communicate key intelligence to the organization in a timely manner.

Assess the regulatory impact of changes to assigned clinical and commercial products

Initiate or contribute to local process improvement initiatives and subsequent procedural development

Develop expertise in assigned product areas and become Subject Matter Expert (SME) for assigned CMC Regulatory activities

Supports the Senior Manager/Associate Director as required

Knowledge, Experience & Skills:

Essential:

Typically requires a BA or BS degree in a relevant discipline and relevant experience in CMC Regulatory Affairs.

Experience in the preparation and maintenance of CMC components of regulatory submissions.

General understanding of CMC regulatory requirements and quality guidelines, including ICH and regional requirements.

Excellent organization skills and ability to work on a number of projects with tight timelines.

Excellent verbal and written communication skills and interpersonal skills.

Desirable:

Regulatory Affairs experience in one or more of the RoW regions.

Relevant industry experience is advantageous.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead

About Gilead:

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 and inflammation, and serious respiratory and cardiovascular conditions.

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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