Senior Regulatory Affairs Manager

Randstad CPE ,
Maidenhead, Berkshire
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Overview

Are you an experienced Regulatory Affairs Manager? Are you looking for a new role? I am looking for a Senior Regulatory Affairs Manager to work within the EU and Lifecycle Division of a leading pharmaceutical business in the Maidenhead area. The senior manager will contribute to the development and implementation of EU regional clinical and pre-clinical regulatory strategy for products post MAA approval, in alignment with the EU business strategy. This is a 12 month contract, within IR35 working at a site in Maidenhead. Key responsibilities: Leading the planning, coordination and preparation of regulatory submissions, supporting the EU Regulatory Lead for products post MAA approval Identify and assess regulatory risks associated with assigned projects and overall product development. Assist in defining strategies to mitigate risks. Provide leadership and represent regulatory on project teams for assigned projects Represent the company for defined projects with local and regional regulatory authorities, contractors and corporate partners Secure alignment between regulatory functions Provide leadership on project teams and subcommittees in all areas of regulatory science and product development Provide input to Regulatory Senior Management teams Provide regulatory guidance to company personnel throughout the research and development process Lead preparation and participate in specific areas of Health Authority Meetings Monitor and analyse appropriate regulatory agency activities in areas of interest to the company and assess impact on assigned programs Build and maintain relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position Actively participate in and contribute to outside relevant conferences, including organizing and delivering presentations May have presence on external regulatory committees/trade associations Responsible for defining strategies for meeting and keeping post approval compliance Interacts with key stakeholders in multiple departments at all levels Interact with a wide variety of outside contacts (including consultants/ contractors, corporate partners and regulatory agency personnel) Experience Requirements: Minimum 5 years pharmaceutical/biotechnology industry experience with technical management experience. With 2 years working in Regulatory Some EU regulatory experience managing submissions preferred. Experience in interpretation of regulations, guidelines and policy statements. Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements. Some direct experience in interfacing with relevant regulatory authorities. Foster effective, positive interactions with regulatory agencies, and corporate partners. Ability to work both independently and with minimal direction and within project teams, committees, etc. to attain group goals. Demonstrate excellent communication skills. Ability to represent the department in project teams, committees and external meetings. Demonstrate strong organizational skills, including the ability to prioritise workload. Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff. Strong sensitivity for a multicultural/multinational environment Want to apply? Please call 07305983934 or email me at Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application. Candidates must be eligible to live and work in the UK. For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business. This job was originally posted as www.totaljobs.com/job/89917018

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