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Partnerships in Clinical Trials 2014

Reference No: J14246

Regulatory Affairs Associate - Senior Regulatory Affairs Associate - Regulatory Affairs Project Manager
Do you want to work with one of the time Times to 100 best companies to work for, with sales of $71.3 Billion in 2013? One of the world largest Pharmaceutical companies in the world are currently working with Regulatory Professionals to successfully secure them a Regulatory Affairs candidate on a permanent basis to be based in their prestigious offices in Buckinghamshire.

Buckinghamshire
Permanent

£30,000 - £50,000 per annum plus benefits

This candidate can be from Regulatory Affairs Associate level (2 years+ experience) to a Senior Regulatory Affairs Associate/Project Manager (approx. 5+ years experience) and will work within our clients Oncology team. The Oncology department of our client is so large that if it ran as a separate business it would still be one of the largest 5 Oncology Pharma companies in the world. Our clients have a real desire and ambition to find a cure for cancers and are known to be making progress and a difference to millions of sufferers in the world.

They have an excellent working environment with the Regulatory team often socialising outside work in team building nights out, they work hard and are focused with a real desire to make a difference in Oncology Drug Development. This role is to work with the lead for approved products working in the Development team, you will be working in an operational and strategic role on Phase 2 and 3 for approved products.

Duties for this role include:
1. 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

2. 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

3. 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

4. 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

5. Marketing Authorization Applications (MAA)
- Provide regulatory support throughout registration process•
- Provide regulatory support throughout life-cycle management•
- Advise team on 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

To be considered for this role you must have a minimum of 2 years Regulatory Affairs experience within a Pharmaceutical company. Drug development experience is essential however Oncology Therapy area experience would be desirable.

Ref: J14246

To apply for this role please email your CV to Aman at aman@regulatoryprofessionals.com or call on 0118 952 2797

Key words: Regulatory Affairs Associate, Reg Affairs, Senior Regulatory Affairs Associate, Regulatory Affairs Project Manager, Oncology, Cancer, CTA, Clinical Trial Applications, Buckinghamshire, MAA, Post Approval, PSURS, Renewals, New Indications, EMEA, Middle East and Africa, MENA, Europe, EU

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