Regulatory Operations Manager
- Permanent
- Regulatory Affairs
This vacancy has now expired. Please see similar roles below...
Hobson Prior are currently looking for Regulatory Operations Manager to join a biopharmaceutical research organisation who specialize in oncology product development and pioneering medicines that are used all over the world. This position will be responsible for managing and maintaining existing development and marketing authorization dossiers and compiling submissions in compliance with ICH specifications and Health Authority regulations globally.
Job Responsibilities:
- Responsible for the timely planning, compiling, publishing, review and delivery of compliant regulatory submissions to Regulatory Health Authorities.
- Maintains and archives all regulatory correspondence in appropriate systems.
- Ensures documents comply with submission ready standards and guidelines and provides guidance with respect to requirements.
- Communicates with vendors for submission support, as needed.
- Partakes in validation or verification testing of templates, electronic document management system, information management and document/submission publishing related tools.
- Provides expertise and support to the user community for RIM systems and EDMS.
- Maintains tracking tools and systems for regulatory information, including submission content plans.
- Support other areas of the company (eg., Business Development) concerning regulatory documentation, as needed.
- Maintains current working instructions for regulatory-related systems (e.g. publishing software, RIM and EDMS.
- Mentors others on submission processes and requirements and may manage contract Regulatory Operations personnel.
Key Skills:
- Excellent organization, communication and writing skills.
- Ability to manage multiple priorities and projects.
- Strong attention to detail and quality.
Requirements:
- Bachelor's degree (in science, technology, health- related field, or business management preferred) or equivalent experience.
- Minimum of three years' experience for Manager and five years' experience for Sr. Manager in a regulatory affairs environment with document management systems, electronic publishing systems and electronic submissions, including eCTD, CTAs, direct submission to global Health Authorities.
- Experience in drug development and knowledge of global regulatory submission content and formats.
- Experience with packaging and labelling, and combination products submissions preferred.
- Strong technical knowledge and working skills in publishing and related computer software including advanced MS Word, Adobe and Adobe plug-ins.
Apply now:
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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