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Regulatory Affairs Associate / Manager

Regulatory Affairs Manager CMC

Calling all Regulatory Professionals! Whether you are a Regulatory Officer/ Executive or Regulatory Manager/Director/Consultant within Regulatory Operations or Regulatory Affairs, we are here to help you escalate your career within the Regulatory sector. Our clients look for experienced candidates within clinical regulatory affairs, through pre-approval and late phase licence maintenance to work within their respective Regulatory Affairs or Regulatory Operations departments.


The Company
Our client is a research based biopharmaceutical company, rapidly growing to become one of the largest globally. They have a very strong pipeline of developing products and an excellent portfolio of marketed products. This is a fantastic opportunity to take on a regulatory affairs manager role and work for a company that has an excellent reputation in the industry for being a great place to work and truly valueing their employees!

The Role
As a Regulatory Affairs CMC Manager you will be working on CMC aspects of pre-and post-approval regulatroy submissions for the companies portfolio of developing and marketed products in the UK and preparing CTAs in Europe. You will also be responsible for managing and prioritising the workload for two regulatory affairs executives.

Duties and Responsibilities

*Co-ordinate and manage the preparation of CMC submissions and maintenance of licenses for Atripla in Cambridge assigned territories

* Co-ordinate and manage the preparation of CMC submissions and maintenance of national licenses for AmBisome in Cambridge assigned territories

* Co-ordinate and manage the preparation of CMC submissions and maintenance of licenses for Hepsera in Cambridge assigned territories

* Preparation of Quality Components of IMPD submissions for investigational new drug CTA applications in Europe

Qualifications and Experience

*Excellent verbal and written communication skills and interpersonal skills are required.
*Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an in-depth understanding of current global and regional trends in Regulatory Affairs.
*Must be capable of developing and implementing regulatory strategy and of managing negotiations with Regulatory Authorities.
*Must be capable of leading a small team in preparation of submissions and maintenance of licenses.
*Work is performed with no immediate direction from a senior Regulatory Affairs professional.
*Demonstrated ability to act as primary company contact with Regulatory Authorities.
*Previous people management experience is desirable.
*Direct experience working with Regulatory Authorities in assigned territories is required.
*Experience representing Regulatory Affairs on submission teams is mandatory and on Project Teams is desirable.]
*UK experience essential.

Key Words: Regulatory Affairs, CMC, Regulatory Affairs Manager, Regulatory Submissions, Regulatory CMC, Chemistry, Manufacturing, Control, CTAs, MAAs, Regulatory Strategy, Product Licences, Licence Maintenance, Hertfordshire, Cambridgeshire, Bedfordshire, Northamptonshire, Relocatable.

We are dedicated to the clinical research industry, offering candidates a unique service including our free \"Pipeline Watch\" career advisory consultation. To find out more call us on 0118 9594990 or email apply@clinicalprofessionals.co.uk