Associate Director, Regulatory Affairs, Global CMC - Oxford

Key People


Job ID :

15362


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 - £85000.00 per annum + share scheme, bonus, car allowance


Date Posted :

04 Oct, 2019



Company Name :

Key People


Location1 :

Oxfordshire




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

We are currently recruiting for an Associate Director Regulatory Affairs to join an International Biopharmaceutical company based in Oxfordshire and specialising within Oncology and Neurology. This is an exciting time to join a growing company with a strong portfolio and pipeline of products.

Responsibilities:
*Planning and co-ordination of the authoring and reviewing of Module 2 (QOS) and Module 3 sections of regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents), as assigned.
*Leads functional/department multi-disciplinary teams in complex, business critical projects to establish Regulatory CMC strategies for commercial products and/or, late, and early stage development programs. Solve unique and complex problems that have a broad impact on the function and/or broader department.
*Regularly interacts with functional leaders, and in some cases senior leadership and/or major customers, on matters concerning functional area, business unit or additional business areas., including regulatory agency interactions.
*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.
*Ensure continued regulatory compliance of products though adherence to the change control procedures and completion of regulatory impact assessments for assigned commercial products.
Required Knowledge and Experience:
*Demonstrated understanding and strategic application of regulations and guidelines for drug development and commercial supply.
*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.
*Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators.
*Demonstrated ability to influence and impact their functional area and department practices
*BSc/BA with a minimum of eight years of regulatory CMC experience.
*English language - written and verbal communication skills.

For further details about this role, or other vacancies within Regulatory Affairs, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk


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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