Regulatory Affairs Consultant

Job Details

An excellent position has become available working for a Global Pharma company with an office based in West London. Our client are looking for a Regulatory Affairs Therapy Consultant for a 6 month on site contract.

To ensure that appropriate content for a range of submissions is developed to agreed timeframes.

This role will require leadership of submission teams for a range of applications potentially including clinical sections to NCE files and CTA's / together with a range of submissions required to maintain existing product licenses in Europe and Asia Pacific Japan and Emerging Markets (APJEM).

The individual will take full accountability of all aspects of the assigned tasks in support of an overall project including ensuring full compliance with company process and policy as they apply to the role.

Responsibilities and Accountabilities

Reporting to the Regulatory Practice Director, the job holder is accountable for delivery of assigned submissions, file or strategy components under supervision of Global Regulatory Lead (GRL) or Regional Representative (RR). Within this supervision, plans own, and submission team, activities to ensure delivery. May be part of the Regulatory Matrix Team for the given asset and accountable for leadership of relevant submission team. The job holder will work with staff from other functions, and should be capable of working to senior levels in development functions in provision of advice, interpretation of relevant guidance's, researching topics and resolving issues. In performing this role the job holder:

* Will take primary responsibility is for leadership of, preparation and review of day to day submissions with full accountability for delivery.
* May also take accountability for larger submissions as part of an overall project plan i.e. line extensions, major components of a submission of a NCE, major responses etc
* May, working with GRL or RR, develop components of regulatory strategy for a region.
* Ensures quality of both own and submission team work and compliance with regulatory guidelines and process within the required timelines.
* May be required to liaise with Regulatory Agencies to resolve straight forward issues in relation to their accountabilities.
* May be responsible for the implementation of the submission strategy with APJEM for an assigned marketed product or product in development.
* May be responsible for the maintenance activities associated with an approved product, including product renewals, label harmonization etc

Experience, Skills and Specialized Knowledge Required

* Bachelor degree or preferably PhD in biological or healthcare science
* Knowledge of the drug development process
* Knowledge of regulatory agency guidelines and expectations for submissions and ability to interpret as required
* Knowledge of regulatory agency review processes globally for both marketing applications and clinical trial applications.
* Experience working in the Cardiovascular therapeutic area would be advantageous

Are you available or interested?


Are you available or interested?


To apply, please click on the Apply button. Ideally, 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 Luke Webber on +44 (0) 207 440 0635 or upload your CV on our website. Full description available on request.

Please note that not all of our vacancies are advertised. To register as a priority candidate, please upload your CV on our website with a short description of what you are looking for or call 0800 988 4437. We will then contact you with relevant roles: www.proclinical.co.uk. We regard all correspondence as confidential.

Proclinical is a specialist Employment Agency and Recruitment Business, providing employment opportunities within major companies in the Pharmaceutical and Biopharmaceutical industries across Europe.