Regulatory Affairs Associate Director
Oncology Cell Therapy
Posted on 10/30/2022
INACTIVE
Critical disease biopharmaceutical development
Company Overview
Gilead’s mission is to discover, develop and deliver innovative therapeutics for people with life-threatening diseases. The company is committed to creating a healthier world for everyone through their research, development of forward medicines, and clinical trials.
Biotechnology
Company Stage
N/A
Total Funding
$15.9B
Founded
1987
Headquarters
Foster City, California
Growth & Insights
Headcount
6 month growth
↑ 1%1 year growth
↑ 5%2 year growth
↑ 6%Locations
Uxbridge, UK • Cambridge, UK
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Communications
CategoriesNew
Legal & Compliance
Biology & Biotech
Requirements
- 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
- 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
- Experience in developing and implementing regulatory strategy
- Life Science degree and demonstrated relevant regulatory affairs experience
- Experience in both pre- and post-approval activities for EU medicines approved via the centralised procedure
- Experience in clinical trials applications/amendments in the European Union and good breadth of understanding of European regulations relating to clinical trials
- Good knowledge of regulatory affairs across the European region
Responsibilities
- Defining the regional regulatory strategy for development or marketed products in conjunction with regional director
- Interacts with the Global Regulatory Lead to agree and ensures delivery of the regulatory strategy in ACE for both development and commercialised medicinal products
- Responsible for the preparation and/or oversight of complex regulatory submissions which require interaction with cross-functional teams to ensure optimal execution
- Prepares and/or co-ordinates submissions for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures
- Prepares and/or co-ordinates regulatory documentation to support early phase development which may include Clinical Trial Applications/ amendments and Paediatric Investigation Plans
- For commercialised medicinal products, interact with cross functional teams to develop strategy on the delivery of post-authorisation safety commitments
- Represents International Regulatory Affairs (Int RA) at cross functional submission/study management team meetings
- Responsible for maintaining a working knowledge of EU regulatory requirements and guidelines and for communicating changes in regulatory information to cross-functional teams
- Ensuring regional product labelling is created and maintained in alignment with the Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI)
- Striving to ensure direct reports learn and develop aspects of regulatory strategy and research, to lead or contribute to regional strategies
- Participate in trade association activities to help shape the regulatory environment
- 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
- Highly motivated and works independently with limited direction from a senior Regulatory Affairs professional
- A good scientific background and understanding with the ability to acquire therapy area and regulatory knowledge in a short timeframe