Regulatory Affairs Senior Associate job in Maidenhead, Berkshire

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This vacancy has now expired. Please see similar roles below...

Proclinical is working with a medium sized east coast US biopharma specializing in rare diseases. They are looking to appoint a Regulatory Senior Associate to work with the head of Regulatory Affairs to maintain the company's marketed product for a rare disease.

This is an excellent opportunity for a regulatory professional to gain first hand practical experience of working with a high value drug which improves patients' lives dramatically. Ideally you will have experience in post approval EU regulatory affairs with some exposure to centrally approved products and have a track record of submission of variations/renewals etc to EMA.

Job Responsibilities:

For the lead commercial product, responsible for leading Life Cycle Management regulatory activities within the International region (EU & other ex-US territories). Vital to build strong links with other functions to assure timely regulatory submissions, for example labelling updates, CMC changes, new indications, line extensions, and annual reporting requirements.
Lead the preparation and submission of new MAAs to support geographical expansion.
Provide regulatory guidance to cross-functional project teams.
Establish and maintain strong relationships with Regulatory Agencies, CROs, third party vendors and operating companies.
Responsible for ensuring products are in line with ICH and local requirements, as well as company policies and procedures.
Maintain knowledge of complex regulatory requirements, contribute to preparation of new regulatory guidance wherever possible, comments on draft regulatory guidance and communicates changes in regulatory information to project teams and senior management.
Participate in industry trade groups and regulatory affairs professional societies
Prepare and implement new SOPs and/or changes to current SOPs.

Skill and Requirements:

BSc or MSc in scientific discipline or equivalent required.
Demonstrable regulatory affairs experience in EU and ex-EU markets in the post-authorisation phase. Experience of the rare diseases space and would be advantageous.
Must have a good knowledge of International/ICH regulatory requirements and the ability to assess the impact of these requirements to the business.
Excellent verbal, written, organisational and interpersonal communication skills are required.
Ability to work on a number of parallel projects, often with tight timelines; able to set priorities.

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 +44 203 078 9544 or upload your CV on our website - www.Proclinical.com.
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.