Regulatory Affairs Senior Manager CMC for Biologicals - Cover early & late phase development projects

Reference: TM071019A

Expiry Date: 07-11-2019

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Maidenhead
Windsor and Maidenhead
United Kingdom

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Job Description

Regulatory Affairs Senior Manager CMC for Biologicals - Cover early & late phase development projects

Location: Near Maidenhead, Berkshire, South-East

This role is good mix of strategic input, global project management and covers  early & late phase development and global registration activities. Promotion prospects are very strong and there are options available to become a technical CMC specialist or move into people/team leadership.

ADV Talent Partners have a new Regulatory Affairs CMC role based at the Head Office of one of the world’s most dynamic and successful Biotechnology Company.

The salary and package is exceptional for this role, including a strong basic salary + bonus + shares options + full healthcare and medical + strong pension + high level re-location package included. There is also a great onsite restaurant, flexible working hours, extensive parking available, good transport links and many company clubs & events to ensure a great work-life balance!

Role / Description: You will be the regional lead providing regulatory affairs CMC insight and intelligence on the regions to foster best approaches, from developing regional CMC RA strategies through to the preparation and submission of CMC documentation for development and registration / lifecycle in EU and all major Global regions (including Asia Pac, LatAm and China).

You will need to be strong in leading regional CMC strategies through to fulfilment, optimising timelines where possible by working well with cross functional departments and your colleagues in Global (Therapy) Regulatory. 

There are many reason to join this amazing organisation including a dynamic, creative & energising culture, an expansive and strong pipeline, multiple opportunities for personal development and the freedom and flexibility to have a strong strategic input into your projects.

You will need at least 6 years of Regulatory Affairs CMC experience and be ready for a role where you have real autonomy, scope and responsibility for a varied Biological product portfolio, working on indications in different stages of development.

 

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Theo Moore on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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