Senior Regulatory Manager - London - UK / IRE

ProClinical Ltd
London (Greater)
09 Mar 2018
15 Mar 2018
Contract Type
Full Time
A leading US biopharmaceutical organisation with a solid commercial portfolio of life-saving drugs within a number of therapy areas have a new Senior Regulatory Manager job opportunity at their offices in Central London. The company has a growing pipeline of investigational drugs and approximately 5,000 employees in offices across four continents. This role will be responsible for working with local Regulatory Authorities and other stakeholders to ensure that the company complies with countries (UK & Ireland) applicable legislations and regulations pertaining to our portfolio (at all stages of the product's life cycle) i.e. ensure that the company's medicinal products can be developed, authorized and maintained on the market.

Job Responsibilities:

* Works proactively to build and maintain contacts with MHRA/HPRA personnel.
* Lead interactions with other departments/functions for response to MHRA/HPRA.
* National Scientific Advice and pre-submission meeting preparation and follow-up.
* Act as a back-up for MHRA/HPRA inspections.
* Supports Quality defects / falsified or counterfeit products / batch recall management.
* Supports Out of stock situation management.
* Supports management of incidents involving regulatory matters (as required).
* Supports Dear Healthcare Provider Communications submissions and follow-up until approval.
* Manages Risk Minimization Measures submissions and follow-up until approval.
* Responsible for all aspects of the regulatory affairs for a product or products in an affiliate capacity.
* Responsible for preparing regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures.
* Responsible for submissions which may include safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations. Preparing or contributing to preparation of original clinical trial applications and contributing to preparation of marketing authorizations for assigned product(s) and helping junior staff where necessary.
* Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license for assigned products and territories and helping junior staff where necessary.
* Establishes and maintains good and strong relationships with all functional areas of the local organization (Medical Affairs, Commercial, Market Access, Legal, etc) and with the company's RA in order to ensure the success of local and international business results from the regulatory point of view
* Technical expertise in a specific function within Regulatory Affairs including GDP and Advertising.
* Decision Making: Makes important decisions that impact the department and ensure appropriate communication
* Initiates or contributes to local and / or global process improvements which have a significant impact on the company.
* Represents Regulatory Function at internal meetings.

Skills and Requirements:

* Typically requires a degree in a scientific field and/or master in regulatory affairs and 10+ years of relevant experience in regulatory affairs. Degree in a scientific field is preferred.
* Extensive experience in and understanding of role of RA and regulatory requirements in Pharmaceutical / Biotech Industry including ICH requirements and regional requirements and understand current trends in the local
* Very good influencing and negotiating skills. Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
* Excellent decision-making skills; makes important decisions that impact the department and ensures they are proactively and appropriately communicated
* Excellent verbal, written, organization skills and interpersonal communication skills.

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 Phone number removed or upload your CV on our website - URL removed
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.

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