Senior Regulatory Consultant - Buckinghamshire

Recruiter
CK Clinical
Location
Buckinghamshire
Posted
20 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Mary Bolt is recruiting for a Senior Regulatory Consultant to join a highly established research-based pharmaceutical company at their site in Buckinghamshire. This position is a contract role for the duration of 12 months. The main purpose of the role will be to:-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 and 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.-Establish and maintain strong relationships with Regulatory Agencies and effectively negotiate with Regulatory Agencies on product-specific labeling, study design, submissions content, and post-approval commitments as well as manage, conduct and facilitate contacts/meetings with Regulatory Agencies and ensure that issues raised by Regulatory Agencies are promptly and adequately addressed.-Advise the team on required documents and submission strategies in preparation of CTA and ensure that CTA submission packages are complete and available according to agreed timelinesFurther responsibilities will include:-Being responsible for the submission and acceptance of MAAs and managing submissions, defining submission plans, and advising the team on required documents and submission strategies in preparation of MAAs (in collaboration with LOCs as appropriate).-Determining resource requirements for assigned projects and anticipating needs for major filings and provide line management, coaching and guidance to Regulatory Professionals as appropriate.-Ensuring that necessary regulatory activities are planned and adequately tracked in company systems and provide regulatory support throughout the registration process and life-cycle managementIn order to be considered for this role, you will be required to have the following qualifications, skills and experience:-Educated to Degree level or above in life science or a related field with a breadth of regulatory experience in drug development and commercialisation (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas).-Extensive experience in Regulatory Affairs incuding an in depth knowledge of the regulatory environment, guidelines and practice of EMEA regions and experience with EU regulatory procedures (CP, MRP, national).-Strong negotiating, people management, project management, communication, organisation & multi-tasking skillsPlease note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL41043 in all correspondence.

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