Senior Regulatory Affairs Associate Virology
Senior Regulatory Affairs Associate Virology
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
The impossible is not impossible.
It's simply what hasn't been achieved yet.
Creating Possible drives everything we do. It's evident in our mission and core values. This is how we built a culture of excellence that is fuelled by a passion for improving the lives of people around the world and advancing the care of patients suffering from life-threatening diseases worldwide.
The Virology 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.
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.
We currently have an exciting opportunity for a Senior Regulatory Affairs Associate in the Virology IC & GPS team to support the HIV and Hepatitis portfolio, in particular Hepatitis-D, working with highly experienced regulatory professionals across the whole product lifecycle. The 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. This role will be based in our Cambridge office.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
- Responsible for supporting regulatory strategies and preparing submissions for designated products in the region. These activities range from new product licenses to lifecycle activities and support all regulatory aspects of the application.
- Partner within International Regulatory Affairs and the Development and Commercial organization to operationally support delivery of the agreed strategy.
- Prepare regulatory submissions products in the therapeutic area and execution of agreed strategies within the region
- Establish relationships 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 an understanding of the regulatory environment leveraging internal knowledge and external regulatory intelligence.
- Prepare and maintain labelling to support MAAs and other post-licensing activities. Ensure that any updates to the Product Company Core Data Sheet (CCDS) are implemented in a timely manner.
- Liaise 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
- Participate and contribute to regulatory team meetings and be recognized as a knowledgeable resource for Regulatory Affairs in other departments.
- May participate in efforts across function in process improvements initiatives
- Will use internal electronic systems for planning, preparing, tracking and storing submissions to regulatory agencies
- Working 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/or in the antiviral therapeutic area would be an advantage but not essential
- Strong organizational skills and ability to work on multiple projects with tight timelines.
- Strong communication skills both in writing and verbally
- Methodical attention to detail
- Must have a can do attitude and be hands on as and when required
KEY ROLE-RELATED COMPETENCIES
- Proven track record to plan, prepare and deliver regulatory submissions
- Embrace, and thrive in, a diverse team
- A driven self-starter
- Able to take personal ownership and initiative
EDUCATION and/or EXPERIENCE REQUIRED
- Life Science degree
- A good level of Pharmaceutical Industry experience. Direct regulatory experience is desirable.
COMPANY CORE VALUES
- Teamwork, Excellence, Accountability, Integrity, Inclusion
- Cambridge office.
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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