Senior Manager, Regulatory Affairs- Virology
Senior Manager, Regulatory Affairs- Virology
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 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.
We are looking for a unique individual who is passionate about advancing therapeutics and thrives under pressure. This is an exciting opportunity for a Manager to join the Virology team, which provides leadership and support for Gilead's Virology product portfolio in the EU and also support these products as needed for countries including Canada, Australia, Switzerland and UK.
This opportunity would allow you to strengthen your EU centralised experience in both a pre- and post-marketing setting. As part of the Virology team you will be given opportunities to grow as a regulatory professional and quickly expand your knowledge and experience through the diverse range of regulatory activities you will be involved with. Each role within the team is highly visible and has a direct impact on bringing Gilead's therapeutics to patients.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
- Co-ordinate regulatory submissions for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
- Responsible for the preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs.
- For licenced products, prepare and/or co-ordinate the submission of non-clinical, clinical and safety regulatory documentation in accordance with regulations, post licensing commitments and legal obligations of the Marketing Authorisation Holder via the European Centralised procedure, e.g. PIP commitments, variations, responses to questions, PSURs etc.
- For investigational medicinal products, prepare and co-ordinate regulatory documentation to support early phase development, including Clinical Trial Applications/ amendments and Paediatric Investigation Plans
- May be required to lead one or more teams in the preparation of European Union Marketing Authorisation Applications (Centralised Procedure) for Virology products in development.
- Responsible for ensuring regional product labelling follows the Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI) and ensuring that any updates to the CCDS or CCSI are implemented in a timely manner.
- Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the marketing authorization.
- Contributes to the development of regional strategic regulatory advice as appropriate.
- Interacts with the Global Regulatory Leads to ensure optimal execution of the agreed regulatory strategy for licenced and development medicinal products.
- Interact with cross-function teams to ensure optimal execution of the agreed regulatory strategy for investigational medicinal products.
- Acts as regulatory project team representative for specified products.
- Represent International Regulatory Affairs (Int RA) function at cross functional submission/study management team meetings.
- Maintains a working knowledge of EU regulatory requirements and guidelines and able to communicate changes in regulatory information to cross-functional teams.
- Supports the Virology team as required.
- May contribute to training of staff and coaching other colleagues as required.
- Initiates or contributes to local and / or global process improvements which have a significant impact on the business.
- Excellent verbal and written English communication skills and demonstration of excellent interpersonal skills are required.
- Excellent planning and organisational skills with the ability to work simultaneously on a number of projects with tight timelines
- Demonstrated effectiveness in cooperation and teamwork with analytical and assessment skills.
- Planning and information seeking skills and ability to work on specific tasks with minimal supervision.
- Problem solving, strategic thinking skills with ability to impact and influence
- Experience in developing and implementing regulatory strategy
- Attention to detail with accuracy and quality
- Ability to understand and effectively relate to external and internal customers
- Business awareness and professionalism
KEY ROLE-RELATED COMPETENCIES
- Able to facilitate/impact and influence effective planning interactions and discussions
- Able to effectively interact with external parties to information gather and effectively drive projects through to completion to tight timelines.
- A good scientific background and understanding with the ability to acquire this knowledge in a short timeframe.
- Work is performed with limited direction of a senior Regulatory Affairs professional. Is recognized as a knowledgeable resource for Regulatory Advice on specific topics in other departments.
EDUCATION and/or EXPERIENCE REQUIRED
- Life Science degree and demonstrated relevant regulatory affairs experience
- Good knowledge of regulatory requirements for the EU centralised procedure
- Experience in co-ordinating post-approval variations, renewals, responses to questions, PSURs etc. for EU centralised products is desirable.
- Experience in clinical trials applications/amendments in the European Union and good breadth of understanding of European regulations relating to clinical trials would be advantageous.
- Experience in working with document management systems
COMPANY CORE VALUES
- Teamwork, Excellence, Accountability, Integrity, Inclusion
You can be based at Stockley Park or 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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