Associate Director, Regulatory Affairs, Global CMC - Oxford

Key People

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Job ID :

11001


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Oxfordshire,Oxfordshire,


Key Skills :

cmc, regulatory affairs, associate director, senior manager, manager, director, biologics, module 3


Salary :

£70000 - £80000.00 per annum


Date Posted :

06 Apr, 2018



Company Name :

Key People


Location1 :

Oxfordshire




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

My client, a well established Oxford based Biopharma, currently seeks a CMC professional at Senior Manager / Associate Director level to join their team. Within this role you will be responsible for Global CMC and managing and leading registration and CMC regulatory support for commercial and development projects worldwide.

Essential Job Functions:

*Planning and co-ordination of the writing and reviewing Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents).
*Leads functional/department multi-disciplinary teams in complex, business critical projects to establish Regulatory CMC strategies for commercial products, late, and early stage development programs.
*Provide in-depth reviews of protocols, reports, presentations, and documents, anticipating internal and/or external business challenges and/or regulatory issues
*Coordinate the preparation and timely submission of responses to regulatory agencies. Manage timelines to ensure approvals are timely and development objectives are met.
*Monitor EU and US CMC regulations, and assess any changes to ensure all development activities are in compliance with applicable current regulations and guidelines.

Required Knowledge, Skills, and Abilities:

*Strong large molecule / biologics background experience
*Demonstrated understanding and strategic application of regulations and guidelines for drug development.
*Demonstrated knowledge of CMC regulatory and ability to generate clear, well-argued positions.
*Must have experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs).
*Demonstrated understanding of FDA, EMA and ICH guidelines.

For further details about this role, or for a confidential discussion about other opportunities within Regulatory Affairs, please contact Tim Barratt on +44(0)1727 817 626 or send a copy of your CV to tbarratt@keypeople.co.uk

Key People is a recruitment consultancy with a reputation for providing good value that's been built up over 20 years. Clients come to us for three main reasons:
> We achieve results faster
> Our candidates really are a cut above
> We add greater value we think it's because we're a private company driven by clients, not by shareholders.
For our candidates, we have developed relationships with thousands of clients nationwide, throughout Europe and also many around the globe, who choose to recruit through Key People, so you'll have a wide choice of opportunities to further your career. And, as we work for 75% of FTSE 100 companies, you'll get the chance to work for some prestigious, blue-chip organisations.


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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