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.