Regulatory Affairs Manager

Regulatory Affairs Oncology Cell Therapy - contractor role

12 month contract

Can be based remotely in the UK or at Stockley Park or Cambridge

37.5 hours per week

Competitive hourly rate

Applicants must be based in the UK upon application to be considered

We are looking for a unique individual who is passionate about advancing therapeutics and thrives under pressure. This is an exciting opportunity to join our client's Cell Therapy team based in Cambridge or Stockley Park. In the role you, will be responsible for regulatory strategy for advanced therapy medicinal products (ATMP) that treat cancer in EU and core international markets (Switzerland, UK, Australia and Canada, 'ACE').

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

• Support and may lead regulatory activities associated within an indication for ATMP, ensuring regional product labelling is created and maintained in alignment with the Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI).
• Develops regulatory strategic options to support business decision making and help optimise the pathway to regulatory filings.
• 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.
• Prepares and co-ordinates regulatory documentation to support early phase development which may include Clinical Trial Applications/ amendments and Paediatric Investigation Plans.
• 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.

CORE COMPETENCIES

• 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 co-ordinating post-approval variations, renewals, responses to questions, PSURs etc. for EU centralised products would be advantageous.
• 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 working with document management systems.