Manager, Regulatory Affairs CMC
Manager, Regulatory Affairs CMC
United Kingdom - Cambridge
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
A career within Gilead's lean, fast paced regulatory team will give you the opportunity to grow your experience quickly. Working with an experienced team of regulatory leaders each role within the Regulatory team is highly visible and has a direct impact on bringing Gilead's therapeutics to patients quickly.
As a result of a strong drug pipeline Gilead's Regulatory team in Cambridge is currently looking for a Manager Regulatory Affairs CMC. This role will provide CMC regulatory support for Gilead's investigational and commercial products across Europe, with a focus on supporting products in Hepatitis C, Oncology and Emerging Viral Diseases therapy areas, including Epclusa, Magrolimab, and Veklury.
This opportunity will offer you the chance to grow your Regulatory Affairs CMC expertise across a range of territories with diverse regulatory requirements and processes and an evolving regulatory landscape.
Under general direction, the Manager RA CMC will be responsible for;
- Preparation and/or coordination of regulatory submissions for Gilead's investigational and commercial products in the EU and International markets, primarily supporting the HCV, Oncology and Emerging Viral Diseases programs. This could include support of major MAA submission filings in EU, Great Britain, Switzerland and Israel.
- Preparation of high-quality chemistry, manufacturing and controls (CMC) documentation to support original MAAs, variations and renewals.
- Preparation of Quality components for investigational medicinal products to support clinical trial applications and amendments in the EU and International markets.
- Co-ordination of responses to CMC questions from regulatory authorities.
- Providing input on CMC regulatory requirements to manufacturing and pharmaceutical development groups for clinical trials, new product registrations and post-approval changes.
- Providing regulatory assessments for proposed changes to investigational and commercial products.
- Maintaining an up-to-date awareness of CMC regulatory requirements for applicable territories and communicating key intelligence to the organization in a timely manner.
- Initiating or contributing to local process improvements which have an impact on the working of the Regulatory Affairs function or other departments.
The Manager RA CMC will work closely with international colleagues to ensure consistency with responses to questions, and with pharmaceutical development, manufacturing, QA and external partners to deliver the CMC components for CTAs, marketing applications, variations and renewals.
Knowledge, Experience & Skills
- 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 for regulatory submissions.
- General understanding of CMC regulatory requirements and quality guidelines, including ICH and regional requirements.
- Excellent organization skills and ability to work on several simultaneous projects with tight timelines.
- Excellent verbal and written communication skills and interpersonal skills.
- Regulatory Affairs CMC experience of investigational and commercial products.
- Relevant industry experience is advantageous.
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:
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