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Job Details

GPRM / RegCMC Senior Manager

Company: ProClinical Ltd
Location: Basel
Reference: RA.SW.17104
Closing Date: 25 Jun 18
Type: Contract
Salary (£): Negotiable
Benefits:

Job Summary:

A job vacancy for a GPRM / RegCMC Senior Manager has arisen at a leading global pharmaceutical company specialising in development of biological therapies. This company is one of the top 10 global pharmaceutical companies that operates in 140 countries worldwide and has market leading products in multiple therapy areas.Maintenance of product licences world-wide for assigned company registered products. ...

Requirements:

A job vacancy for a GPRM / RegCMC Senior Manager has arisen at a leading global pharmaceutical company specialising in development of biological therapies. This company is one of the top 10 global pharmaceutical companies that operates in 140 countries worldwide and has market leading products in multiple therapy areas.

Maintenance of product licences world-wide for assigned company registered products. The GPRM is responsible for the operational execution of specific regulatory deliverables relating to world-wide maintenance, upkeep and lifecycle management of assigned global portfolio brands. This may include preparation of all necessary supporting documentation for EU license renewals, EU variations, PSUR submissions; addressing HA requests and leading preparation of HA responses; managing interactions with RA colleagues in CPOs, participation in regulatory sub teams; preparation of IND/NDA Annual Reports & DSURs.

Job Responsibilities:

* Lead and coordinate timely and high-quality preparation of all necessary supporting documentation by internal or external experts for EU license renewals, EU variations (except CMC-related variations), PSUR submissions for assigned company registered products
* Provide operational support to Global Program Regulatory Director and/or Global Therapeutic Area Leader in addressing compliance-related issues arising on Established Medicines portfolio including input to Urgent Safety Restrictions (USR) and the preparation of internal and external communication documents to the EU HAs involving multiple countries.
* Lead/provide input to solve regulatory issues related to assigned company registered products, as appropriate.
* Lead the HA Response Team through the regulatory maintenance processes. Represent RA in negotiations with HA in EU in liaison with DRA CPOs or the company. Provide prompt and complete responses to regulatory relevant queries from various stakeholders (e.g. HAs, CPOs) relating to assigned brands.
* Manage the interaction with RA colleagues in Country organizations.
* Partner with US GPRM in preparation of IND/NDA Annual Reports and US PI changes driven by CDS update for assigned Established Medicine brands.

Skills and Requirements:

* These largely compliance-related activities require a more extensive regulatory knowledge than for GPRM1, but CRO or other experience should suffice.
* Work Place / site Flexible – travel to Basel to meet team expected. Location on site for occasional days preferred

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 Sam Walker on +44 203 8569 336 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: GPRM / RegCMC Senior Manager

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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