Regulatory Submissions Specialist - new job in Marlow, UK

Regulatory Submissions Specialist
  • Competitive
  • Contract
  • Marlow, Buckinghamshire, England, UK Marlow Buckinghamshire UK SL7 1YL
Job Ref: BBBH129763
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 16 May 2023
SRG are currently looking for Regulatory Submissions Specialist for a Global Pharmaceutical Company who have opened a new vacancy within their team.

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.

15/06/2023 10:41:38
GBP 25.00 25 Hour
Contact Consultant:
Corinne Laurence

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