Regulatory Affairs Consultant - Senior

ProClinical Ltd
High Wycombe
09 Mar 2018
15 Mar 2018
Contract Type
Full Time
A leading multinational pharmaceutical, and medical devices company currently has an attractive job vacancy available for a Senior Regulatory Affairs Consultant to be based in their High Wycombe office.

Job Responsibilities:

* Advise the Project Team and/or Regional Therapeutic Area Leader on applicable regulatory issues, project-specific regulatory issues, and issues related to regional regulatory climates
* Drive understanding of central and national regulatory requirements
* Develop and ensure effective implementation of regional (central and national) regulatory strategy and tactics in support of the global development and life-cycle management plan
* Develop a deep understanding of the regional regulatory environment, competitor intelligence and therapeutic area
* Provide input for developing and updating the Target EU SmPC based on an understanding of the implications of regional regulatory strategy for labelling
* Ensure appropriate implementation of scientific advice / Regulatory Agency comments into development and life-cycle management plan
* Establish and maintain strong relationships with Regulatory Agencies and effectively negotiate with Regulatory Agencies on product-specific labelling, study design, submissions content, and post-approval commitments
* Act as primary contact with EMEA. Work through LOC and/or CRO for National Regulatory Agencies contacts, as appropriate
* Ensure appropriate involvement and liaise with LOC regulatory affairs personnel to facilitate local Regulatory Agency meetings
* Determine timing and strategy for Regulatory Agency meetings and scientific advice
* Prepare team, manage, conduct and facilitate contacts/meetings with Regulatory Agencies. Define attendance in consultation with GRL and CDT. Issue minutes and contact reports and disseminate correspondence, faxes, contact reports from contacts with Regulatory Agencies
* Ensure that issues raised by Regulatory Agencies are promptly and adequately addressed
* Negotiate labelling with Regulatory Agencies, going through each of the back-up strategies if necessary 3. Input in document and process development
* Advise team on required documents and processes to support Regulatory Agency contacts and submission

Skills and Requirements:

* University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
* Breadth of regulatory experience in drug development and commercialization (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas)
* Experience with EU regulatory procedures (CP, MRP, national)
* Experience in working in project teams and/or a matrix organization Skills
* Negotiating and conflict handling skills
* People management skills
* Complex project management skills
* Oral & written communication skills
* Organization & multi-tasking skills Knowledge
* Excellent knowledge of English
* Knowledge of the applicable therapeutic area
* In depth knowledge of the regulatory environment, guidelines and practice of EMEA regions 2. Job Description

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 Peter Duvall 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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