Associate Director Established Products - Cambridge

Recruiter
CK Clinical
Location
Cambridgeshire
Posted
19 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Mary Bolt is recruiting for an Associate Director Established Products to join a leading, privately owned, global pharma with significant presence in several therapeutic areas at their site based in Cambridge on a permanent basisThe main purpose of the role will be to:-Work collaboratively with outsource partners to ensure efficient and timely provision of regulatory services to maintain and expand the established product portfolio as well as developing and leading regulatory strategies for established products across all therapeutic areas.-Plan, coordinate and prepare MA Applications for submission to fulfil commercial expansion plans, manage the maintenance of MAs via renewals and variations and coordinate and respond to questions from Regulatory Agencies during MA applications, MA renewals and variations.-Provide pharmaceutical, preclinical, clinical and other technical information to the group and Licensees, to assist with the registration and maintenance activities of existing MAs.Further responsibilities will include:-Plan and coordinate responses to regulatory questions regarding products and provide regulatory advice and expertise to the group and commercial Established Brands team as well as providing expert advice on items or issues which affect the Company and Regulatory teams.-Be aware of and keep up to date with current legislation appropriate to Regulatory Affairs and take a high degree of personal responsibility for representing the Department both internally and externally, decision making and problem solving.-Ensure, where appropriate, that the electronic document management system is used for all submission documents and maintain records of tasks, activities and registered product information in the internal regulatory databases.In 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 sciences or a related field with extensive regulatory experience including MA maintenance / lifecycle management and a track record of overseeing a substantial number of post-approval products including geographical expansions into MEA, APAC and LATAM.-A strong strategic regulatory mind-set and demonstrated ability in developing regulatory strategy in line with commercial goals as well as the ability to build relationships and inspire confidence and respect at all levels and be an excellent team player.-Outstanding communication skills, the ability to build rapport and demonstrate strong influencing and negotiation skills as well as an excellent listening ability and reception to feedback, demonstrating flexibility, curiosity and an ability to learn.Please 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 CL41017 in all correspondence.

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