Regulatory Affairs Manager (ATMP)

Regulatory Affairs Manager (ATMP)

Gilead

Cambridge, United Kingdom

We are looking for a highly motivated individual who is passionate about advancing therapeutics and thrives under pressure. This is an exciting opportunity for a Manager to join the Kite Pharma (Kite) Cell Therapy team based in Cambridge or Stockley Park, to support development of novel advanced therapy medicinal products (ATMPs). In the role you will be responsible for developing regulatory strategy for ATMP that treat cancer and autoimmune diseases in EU and core international markets. Kite Pharma and the Kite Cell therapy regulatory team works closely with the Gilead Oncology team allowing for real time knowledge sharing and support across oncology programs.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following

• Lead regulatory activities associated with development or marketed ATMP products in conjunction with regional associate director/director.
• Prepares regulatory strategy and documentation to support Clinical Trial Applications/ amendments in the region.
• Interacts with the Global Regulatory Lead to align on and drive delivery of the regulatory strategy in ACE (Australia, Canada and Europe) 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.
• Strong presentation skills, with the ability to clearly articulate regulatory strategy, risks, and decision‑making rationale to cross‑functional teams.
• 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 leading the preparation and submission of regulatory documentation to support centrally approved product with post approval activities, and/or
• Experience in leading 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.