Regulatory Operations Manager
Hobson Prior are working with a leading independent biotech organisation who are looking for a Regulatory Operations Manager to join them on a contract basis in Uxbridge. This position will provide support as an individual contributor to ensure the execution of MRI team objectives.
- Creation, submission and archiving of regulatory dossiers.
- Quality control of regulatory dossiers, archive and tracking systems.
- Maintenance of regulatory document management systems and tracking systems.
- Maintenance of core dossier component structures.
- Primary Regulatory Operations point of contact between TAs/CMC and publishing teams Key Activities.
- Day-to-day issues management and workload balancing.
- Cross-TA information sharing and liaison with TAs/CMC for submission prioritization.
- Ensure timely data entry, administration of, and reporting from regulatory registration tracking system.
- Ensure timely submission of regulatory correspondence to the Regulatory Archive and maintenance of product history logs.
- Liaise with Global RDA teams and CMC system teams to ensure seamless and consistent approach to document management and maintenance of tracking systems.
- Ensure quality control procedures for dossiers, tracking system entries, regulatory archive locations and file naming conventions are in place and adhered to.
- Contribute to the development and roll out of training documentation and e-manuals.
- Ability to work in teams.
- Use of document management systems and databases.
- Good written and verbal communication skills.
- Attention to detail.
- Relationship building.
- Doctorate degree OR Master's degree & 3 years of directly related experience.
- Or either Bachelor's degree & 5 years of directly related experience, Associate's degree & 10 years of directly related experience or High school diploma / GED & 12 years of directly related experience.
- Previous experience leading projects, programs or directing the allocation of resources.
- Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations and Regulatory Guidance.
- General understanding of industry practice and standards.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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