Regulatory Affairs Senior Manager Oncology
Regulatory Affairs Senior Manager Oncology
United 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 Regulatory Affairs Senior Manager to join the Gilead Oncology Team to lead the EU regulatory strategy for high priority oncology programs.
In this role you will be provide regulatory strategy, leadership, and support for Gilead's growing oncology development product portfolio, allowing you to strengthen your drug development experience in a therapeutic area driven by Gilead's desire to bring transformational medicines to those with continued unmet medical need.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
- Leads all regulatory activities associated with the development of Gilead oncology assets (e.g. PIP, Scientific Advice, Orphan Drug Designation).
- Develops regulatory strategic options to support business decision making and help optimise the pathway to regulatory filings.
- Interacts with the Global Regulatory Leads to agree and ensures delivery of the regulatory strategy in EU and Gilead's core international markets (Switzerland, UK, Australia and Canada) for development medicinal products.
- Leads indication extension applications in EU and Gilead's core international markets.
- Acts as Regulatory Project Team representative for specified regions and products.
- Responsible for the preparation of moderately complex regulatory submissions which require interaction with cross-functional teams to ensure optimal execution.
- Co-ordinates submissions for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
- Represents International Regulatory Affairs (Int RA) at cross functional submission/study management team meetings.
- Prepares and co-ordinates regulatory documentation to support early phase development, including Clinical Trial Applications/ amendments and Paediatric Investigation Plans.
- Upon approval of products/ indications, defines the regional regulatory strategy for development or marketed products and ensures regional product labelling is created and maintained in alignment with the Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI).
- Experience in developing and implementing regulatory strategy.
- 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 multiple 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.
- 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
- A good scientific background and understanding with the ability to acquire therapy area and regulatory knowledge in a short timeframe.
- 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.
- Work independently with limited direction from a senior Regulatory Affairs professional.
EDUCATION and/or EXPERIENCE REQUIRED
- Life Science degree and demonstrated relevant regulatory affairs experience.
- Experience in regulatory activities associated with the development of medicinal products in the European Union (e.g. PIP, Scientific Advice, Orphan Drug Designation) is desirable.
- Experience in clinical trials applications/amendments in the European Union and good breadth of understanding of European regulations relating to clinical trials is desirable.
- 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 would be advantageous.
- Experience in working with document management systems.
COMPANY CORE VALUES
- Teamwork, Excellence, Accountability, Integrity, Inclusion.
Cambridge or Stockley Park 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:
Please log onto your Internal Career Site to apply for this job.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-Kingdom---Uxbridge/Regulatory-Affairs-Senior-Manager---Oncology_R0019044-1
Copyright 2017 Jobelephant.com Inc. All rights reserved.
Posted by the FREE value-added recruitment advertising agency