Senior Associate Graas Regulatory Operations

3 weeks ago

Uxbridge, United Kingdom CK GROUP Full time

CK Group are recruiting for a Senior Associate, Regulatory Operations to join a biopharmaceutical company, who are based in Uxbridge on a contract basis for 12 months. This role is inside IR35, and will be hybrid working between the the office in Uxbridgeand home.
**Rates**:
Up to £42.10 per hour, Umbrella or £31.90 per hour PAYE (~£62,205 per annum, pro rata)
**The Company**:
Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human geneticsto unravel the complexities of disease and understand the fundamentals of human biology.
**Location**:
**Senior Associate, Regulatory Operations**:
In this vital role you will ensure technical compliance of Clinical Trial submissions via the smooth compliant flow of information between all functional areas, local offices, external partners, and regulatory authorities.
- You will be assigned to one or more products under development to ensure Clinical Trial Application approvals in the EU. As technical experts in the EMA Clinical Trial Information System (CTIS), ensure compliance with EU Clinical Trials Regulation for everyClinical Trial submission dossier through close internal cross-functional collaboration.
- Coordinate for Clinical Trial Submissions and Notifications in the state-of-the-art Regulatory Document Management System and maintain tracking systems.
- Be the critical technical coordinator for Clinical Trial Submissions and Notifications through the EMA Clinical Trial Information System (CTIS), ensuring accurate and timely input of data into the EMA CTIS system for Clinical Trial Applications, Modificationsand Notifications.
- Be responsible for reviewing and triaging of Requests for Information from Health Authorities through CTIS to relevant cross functional teams.
- Support the EU Regulatory Lead to prepare Submission Content Plans and documentation for regulatory deliverables, for the management of Clinical Trials.
- Assist with definition, development, and implementation of processes to meet the evolving CTIS needs.
- Raise, inform, and resolve any issues that may impact submission process or timelines within CTIS.

**Experience Required**:

- Knowledge and execution of CTA Processes in EU
- Comprehensive understanding of the EU Clinical Trials Regulation, EU Clinical Trials Directive and ICH/GCP
- EMA Clinical Trial Information System (CTIS) experience preferred
- Knowledge of the drug development processes, Regulatory Affairs and Submission Management is highly desirable
- Veeva Vault RIM experience preferred
- Microsoft Office Suites experience
- Ability to quickly learn new software, regulations, and processes
- Proactive, innovative problem solver and well-organized teammate
- Degree educated with experience in pharmaceutical company

**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote reference 54889 in all correspondence.

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