Ra Coordinator

6 months ago


Remote, United Kingdom G&L Healthcare Full time

Job Summary:

- Provide operational regulatory support for assigned programs and/or activities. **Coordinate with other groups within RA to finalize and ensure timely dispatch of Health Authority submissions as aligned with assigned program RA sub-teams. ** Contribute to assigned Module 1 documents including forms and cover letters with oversight of the RA program lead(s). **Support RA sub-team for clinical trial related activities (CTA forms and tracking, transfer of obligations submissions, drug shipment ticket review, etc.). ** Independently manage assigned regulatory compliance and maintenance activities for clinical trial, registration, and post-approval regulatory activities. **Ensure tracking and update of relevant regulatory information in compliance systems and trackers as provided by RA sub-team representatives. Life Cycle Management: In some LCM groups, support of regulatory activities with focus on divestment, pruning & deregistration, and/or procurement of samples and certificates and New Product Planning - under supervision of respective Team Lead. Key Performance Indicators (Describe the main results of the role to be achieved)**

**Qualifications**:

- Experience in conducting and managing clinical trials
- Strong understanding of regulatory requirements in clinical research
- Excellent attention to detail and ability to maintain accurate records
- Proficiency in data analysis and interpretation
- Strong communication and interpersonal skills
- Ability to work effectively in a team environment
- Relevant certifications in clinical research or related field

Pay: £18.00 per hour

Schedule:

- Monday to Friday

**Experience**:

- Regulatory Affairs: 3 years (preferred)
- Clinical trials: 2 years (preferred)

Work Location: Remote


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