Job Description
Job Title: EU Regulatory Affairs Manager
Department: Regulatory Affairs
Location: Uxbridge, UK or Dublin, Ireland – 3x a week in the office
Job Type: 12 Month Contract /FTC
Remuneration: Up to £85,000/€90,000
This is a 12-month contract role, and you MUST be able to start this role within 4 weeks.
An exciting opportunity to work for a global leading and prestigious Biotechnology company that is at the heart of science. They have a new opportunity and growing need for EU-specific expertise on the development programs, as well as to keep the company compliant on emerging EU legislation and processes, which has led to the need to create a new position based
in our Dublin or London office.
The role is positioned at the Manager/Senior Manager level to enable advanced regulatory input to interactions with EU Regulatory agencies and with our business partners. This role will be
focussed on supporting development activities in the area of respiratory and inflammation.
JOB RESPONSIBILITIES:
* Assist Development teams and Regulatory management in developing strategies that are EU-appropriate and take advantage of EU regulatory systems and processes.
* Provide leadership on both late and early-stage clinical development related process and strategy to ensure timely study conduct end to end.
* Assist clinical teams in study start up and maintenance activities by leading all associated regulatory activities, including but not limited to submissions, addressing agency queries, managing compliance issues.
* Take ownership of EU CTR applications, Study Start up and PIPS.
* Provide leadership on MAA related process and strategy to ensure timely product approvals with competitively differentiated labelling.
* Monitor emerging legislation and guidance in the EU and contribute to ensuring company-level awareness and compliance (where appropriate).
* Build the representation of EU regulatory function to EMA and EU National Agencies, as
* well as Alliance partners as required.
JOB REQUIREMENTS:
Education
* Advanced degree in a scientific discipline master’s degree or Ph.D.
Experience
* Minimum of 5 years in Regulatory Affairs ideally in drug development.
* Prior CTA submission experience.
* Prior Cell Therapy experience is preferred.
* Confident in leading EU strategy development.
* Strong knowledge of the clinical research process and regulations/guidelines
* Strong organizational, interpersonal and communication skills
* Ability to manage multiple projects.
For more information, please reach out to lucy.kirkaldy@cpl.com
You MUST be UK/IRELAND based and hold the Full Right to Work