Senior Manager, Regulatory Affairs Virology IC & GPS
United Kingdom - CambridgeUnited Kingdom - Uxbridge
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
The International Regulatory Affairs team is responsible for supporting Gilead to make sound strategic decisions to enable access for patients to our molecules. IC& GPS team is responsible for Intercontinental and Global Patient Solutions which includes territories throughout Asia, Latin America, Africa, Eastern Europe and the Middle East.
The team provides strategic and technical advice from development throughout the whole product lifecycle for all HIV, Hepatitis and Emerging Viruses projects/products. The team's core activities are to plan, prepare and progress new product registrations and subsequent post-approval safety and indication updates. We work cross-functionally with a diverse number of stakeholders both internally and externally to Gilead
We have an exciting opportunity for a Regulatory Affairs Senior Manager in the Virology team, to support the portfolio, to work with highly experienced regulatory professionals across the whole product lifecycle. This role will be based in our Cambridge or Stockley Park office.
The team works on a broad portfolio of products and can offer the opportunity to work on a diverse range of regulatory activities. The team and regulatory department as a whole is built on a strong sense of team work.ESSENTIAL DUTIES AND RESPONSIBILITIES
Responsible for leading regulatory strategies for designated products in the region . This ranges from new product licenses to lifecycle activities and have oversight of all regulatory aspects of the application.
Partner within International Regulatory affairs, the Development and Commercial organization. To collaborate with cross functional partners to ensure optimal execution of the agreed regulatory strategy
Responsible for the preparation of regulatory submissions products in the therapeutic area and execution of agreed strategies within the region
To establish strong relationship with Gilead affiliates and distributor partners and serve as point person for knowledge for their product to these key stakeholders
The person in this role will have a deep understanding of the regulatory environment leveraging internal knowledge and external regulatory intelligence
Responsible for the preparation and maintenance of labelling to support MAAs and other post-licensing activities. Ensures that any updates to the Product Company Core Data Sheet (CCDS) are implemented in a timely manner.
Liaises 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 approved labelling and agreed timelines
Participates and contribute to regulatory team meetings and recognized as a knowledgeable resource for Regulatory Affairs in other departments.
May participate and lead collaborative efforts across function in process improvements initiatives
Will use internal electronic systems for planning, preparing, tracking and storing submissions to regulatory agenciesCOMPANY CORE VALUESTeamwork Excellence Accountability Integrity Inclusion
- Direct experience in regulatory affairs in pharmaceutical industry across International markets and in regulatory submissions.
- In depth knowledge of regulatory requirements, including ICH requirements and regional requirements. Has appreciation of current global and regional trends in Regulatory Affairs.
- Experience of working with Emerging markets and preferably in the antiviral therapeutic area
- Excellent organizational skills and ability to work on several projects with tight timelines.
- Excellent influencing and negotiation skills
- Excellent communication skills both in writing and verbally
- Methodical attention to detail
- Must have a can do attitude and must be hands on
KEY ROLE-RELATED COMPETENCIES
- Proven track record to manage, formulate and execute strategy
- Embrace and thrive in a diverse team
- A driven self-starter
- Able to take personal ownership and initiative
- Adaptive and Flexible
EDUCATION and/or EXPERIENCE REQUIRED
- Life Science degree
- Good level of pharmaceutical experience. Direct regulatory experience with Emerging markets is preferable
- A proven ability to co-ordinate the preparation of a variety of complex regulatory documentation in collaboration with other functions.
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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