Senior Regulatory Consultant
I am currently recruiting for an experienced Regulatory Consultant to join a Top 10 Pharma client based in Buckinghamshire on an initial 12 month contract basis.
The ideal candidate will have a strong full life cycle background with experience ranging from development through to registrations and Post Approval activities.
, Input in development, post-approval and life cycle management
, Participate in global regulatory team meetings as appropriate;
, Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned;
, Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area.
Liaison with Regulatory Agencies and Local Operating Companies:
, Act as back-up for contact with Regulatory Agencies as needed;
, Draft cover letters for Regulatory Agency communication;
, Assist in the preparation of meetings with Regulatory Agencies;
, Liaise with LOCs, track and respond to queries in a timely manner.
Input in document and process development:
, Assist in development of processes related to regulatory submissions;
, Draft and review some document content (depending on level of regulatory knowledge/expertise)
, Provide input to documentation to ensure they thoroughly and accurately answer the questions being posed;
, Track dates of submissions and Regulatory Agency responses.
Clinical Trial Applications (CTA):
, Review protocols and ensure alignment with regulatory requirements;
, Advise team on required documents and submission strategies in preparation of CTAs;
, Ensure CTA submission packages are complete and available according to agreed timelines;
, Review and approve clinical trial supply plans.
Marketing Authorization Applications (MAA)
, Provide regulatory support throughout registration process and life-cycle management;
, Advise team in required documents and submission strategies in preparation of MAA as assigned (in collaboration with LOCs as appropriate)
, Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities;
, Assist with submission and acceptance of MAA;
, Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans.
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email email@example.com
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