Regulatory Affairs Manager - Oncology Cell Therapy

Regulatory Affairs Manager - Oncology Cell Therapy

Gilead

Uxbridge or Cambridge, United Kingdom

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following

• Lead regulatory activities associated with development or marketed ATMP products in conjunction with regional director.
• Prepares regulatory documentation to support Clinical Trial Applications/ amendments in the region.
• Interacts with the Global Regulatory Lead to agree and ensures delivery of the regulatory strategy in ACE for both development and marketed medicinal products.
• Responsible for the preparation of moderately complex regulatory submissions which require interaction with cross-functional teams to ensure optimal execution.
• Prepares and co-ordinates submissions for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
• Represents the Regulatory Affairs function in cross functional teams to ensure optimal execution of the agreed regulatory strategy for both approved and development ATMPs.
• Responsible for maintaining a working knowledge of EU regulatory requirements and guidelines and for communicating changes in regulatory information to cross-functional teams.

CORE COMPETENCIES

• 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.

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.
• Motivated and works 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 the preparation and submission of regulatory documentation to support centrally approved product with post approval activities; and/or
• Experience in clinical trials applications/amendments in the European Union and good breadth of understanding of European regulations relating to clinical trials.
• Good breadth of understanding of the European regulations.
• Experience in working with document management systems.
• Experience representing Regulatory Affairs on cross functional teams.

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