Regulatory Submissions Specialist - new job in Marlow, UK

SRG are currently looking for Regulatory Submissions Specialist for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team on an initial 12 Month basis to be based at their offices in Buckinghamshire. This is a hybrid working opportunity.The Role: To support the creation and distribution of compliant regulatory submissions and provide administrative support for the pre-publishing and post-publishing phases of regulatory submission production and distribution, working closely with vendor publishers and other functions within the business. Key Responsibilities:
Planning/Publishing Regulatory Submissions.
- Support the publishing and planning of regulatory submissions and reports, including MAAs, CTA, Scientific Advice, PIPs, DSURs, RMPs etc.
- Regional Module 1 Planning: Plan and conduct regional M1 meetings.
- Liaise with the relevant functions to ensure Module 1 documents are identified in submission planner.
- Check Module 1 documents for submission-readiness and format as needed.
- Import and approve Module 1 documents into document repository.
- Manage and maintain country-specific Module 1 submission planners.
- Maintain Country Checklists in the Regulatory Requirements Portal.
- Support Submission Team members in the roll out of FDA/EMA submissions
- Represent Submission Team on submission planning meetings.
- Coordinate publishing tasks with the vendor publishers.
- Publish simple submissions and correct simple publishing errors.
- Perform QC of published paper and electronic submissions and maintain required supporting documentation.
- Produce/coordinate production of CDs/DVDs for submission despatch.
- Liaise with printer vendors to create paper outputs for submission despatch.
- Despatch submissions to affiliates or submit via portals, CD/DVD, paper or document exchange sites.
- Archive submissions in electronic repository.
Regulatory Intelligence.
- Interpret regional/local requirements and provide advice and guidance to Regulatory Affairs to ensure submissions meet relevant requirements.
- Prepare and deliver presentations as and when required.
New initiatives and other ad hoc projects
- Develop, implement and maintain submission processes and relevant templates to support JAPAC/WE and EEMEA submissions.
- Track metrics associated with submission publishing and rework.
- Support new initiatives / system updates.
- Mentor and train new starters
Skills/Experience Required:
- Educated to degree level or equivalent experience.
- Good knowledge of pharmaceutical regulations and guidelines.
- Experience in planning/publishing CP, MRP and DCP submissions, including eCTD.
- Good knowledge and experience of all submission types (MAAs, Variations, Renewals, CTAs, ASRs etc.)
- Knowledge/experience in planning/publishing submissions for emerging markets would be ideal.
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
Contact Consultant:
Corinne Laurence
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