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Job Details

Senior Regulatory Affairs Manager (CMC)

Company: ProClinical Ltd
Location: Cambridge
Reference: RA.DN.15428
Closing Date: 28 Feb 18
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

My client is an international biopharmaceutical organisation with an enviable commercial portfolio and deep development pipeline in areas of unmet medical needs. At this time, they are seeking to appoint a senior CMC regulatory Senior Manager to lead a team of professionals covering multiple therapy areas across their portfolio for both pre and post-approval compounds. ...

Requirements:

My client is an international biopharmaceutical organisation with an enviable commercial portfolio and deep development pipeline in areas of unmet medical needs. At this time, they are seeking to appoint a senior CMC regulatory Senior Manager to lead a team of professionals covering multiple therapy areas across their portfolio for both pre and post-approval compounds.

You will be a seasoned CMC professional with extensive regulatory agency interactions experience and a leader with gravitas to influence up as well as down within a matrix organisation. On offer is a unique opportunity to work with an industry leading group on cutting edge therapies at a key time in the company’s history.

Responsibilities include:

* Preparing Quality sections of INDs/IMPDs, new MAAs, CMC variations and renewals for submission in Rest of World (RoW) territories
* Ensuing that dossiers meet ICH and local regulatory requirements
* Ensuring timely discussion with Health Authorities regarding responses to questions, and will work with international colleagues to ensure consistency of responses to International Health Authorities
* Working with Pharmaceutical Development, Manufacturing and QA colleagues to develop regulatory strategy for CMC content and lifecycle maintenance for RoW markets
* Co-ordinating the preparation of responses to CMC questions from regulatory authorities
* Liaising with local affiliates and external distributors to define/clarity CMC submission requirements
* Providing advice to pharmaceutical development and manufacturing colleagues on RoW regulatory requirements for new submissions and for post approval change management
* Maintaining an up to date awareness of CMC regulatory requirements for applicable territories and communicate key intelligence to the organization in a timely manner
* Having line management responsibility for a small team of regulatory associates

Skills and Experience:

* Significant Regulatory Affairs and/or relevant pharmaceutical industry experience
* In-depth knowledge of CMC regulatory requirements, including ICH and regional requirements, and have an understanding of current global and regional trends in CMC Regulatory Affairs
* A proven ability to co-ordinate the preparation of a variety of CMC regulatory documents in collaboration with other functions
* Prior experience in preparation of MAA submissions for new chemical entities or maintenance of product licences in international territories
* Experience representing Regulatory Affairs on cross functional teams
* Direct experience working with Health Authority chemistry reviewers
* Line Management experience

To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call David Nixon on +44 203 0789 544 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Apply for this job: Senior Regulatory Affairs Manager (CMC)

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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