- Defines the regional regulatory strategy for development or marketed products, taking in consideration the latest precedent, regulatory intelligence, agency communications, and guidance.
- Represents Gilead in discussions and at meetings with regulatory authorities (as required).
- Works closely with Global Regulatory Leads to agree and ensure delivery of the local regulatory strategy to cross-functional leaders and teams.
- Leads new indication and/or marketing applications in Gilead's core European and international markets.
- Acts as representative for specific indications at Regulatory Project Team, and with cross-functional teams, for specified regions and products.
- Participates in other sub-teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers) or assign such to other colleagues and oversee and guide their sub-team participation as required.
- Responsible for the content, preparation of moderately complex regulatory submissions, and their optimal execution in alignment with business needs.
- Ensures regional product labelling is created and maintained in alignment with the Company Core Data Sheets and Company Core Safety Information.
- Able to use internal electronic systems for planning, preparing, tracking, and storing submissions to regulatory agencies.
- Contributes to the culture of continuous improvement across regulatory affairs helping team members learn and develop aspects of regulatory strategy and research, to lead or contribute to regional strategies.
- In-depth knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing.
- Detailed understanding of European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards for medicinal products. Understands varying regional or country regulatory requirements for assigned markets.
- Knowledge of current global and regional trends in biopharmaceutical regulatory affairs. Proven effectiveness applying this knowledge to optimize team deliverables and results.
- Clear ability to lead cross-functional teams, and develop, communicate, and implement regulatory strategy.
- Excellent verbal and written English communication skills, and demonstration of excellent interpersonal skills.
- Excellent planning and organisational skills with the ability to work simultaneously on multiple projects with tight timelines.
- Demonstrated effectiveness in cooperation and teamwork, with analytical and assessment skills.
- Problem solving, strategic thinking skills, with the ability to impact and influence.
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Global Regulatory Affairs, Associate Director - Cambridge, United Kingdom - Gilead Sciences International, Ltd.
Description
Description
We are looking for a driven individual who is passionate about bringing transformational medicines to those in Europe and international countries with continued unmet medical need.
This is an exciting opportunity for a Regulatory Affairs Associate Director to join the Gilead Global Regulatory Affairs Oncology team to support drug development and registration of oncology assets. This role is focused on Gilead's ACE region, which includes Australia Canada, European Union, Switzerland, and the UK.
In this role you will need to provide provide regulatory strategy, leadership, and operational support for Gilead's growing oncology development product portfolio, allowing you to strengthen your drug development and regulatory expertise. In the role you will be expected to work cross-functionally with a diverse number of stakeholders both internally and externally to Gilead Global Regulatory Affairs.
ESSENTIAL DUTIES AND RESPONSIBILITIES
COMPANY CORE VALUES
•Teamwork
•Excellence
•Accountability
•Integrity
•Inclusion
CORE COMPETENCIES
EDUCATION and/or EXPERIENCE REQUIRED
Life science degree and demonstrated broad and/or depth of experience in pharmaceutical regulatory affairs across at least the European region, including leadership of major applications and health authority interactions.
LOCATION
Three days a week (Tues/Wed/Thurs) at the Stockley Park (Greater London) or Cambridge UK offices.
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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