Job Regulatory Affairs Manager Berkshire, Buckinghamshire and Oxfordshire Technojobs - job offers
Job description:
I am currently looking for an interim Regulatory Affairs Manager to work for a leading global Pharmaceutical company based in Buckinghamshire on a 1 Year Contract paying up to £60 per hour dependant on experience. Summary: As the Regulatory Scientist, your role will be to provide support to the Regional Regulatory Liaison, Regional Therapeutic Area Leader and/or Global Regulatory Leader (GRL) for regulatory activities for products in the assigned portfolio, including assuring that content and intent of regulatory filings support the global regulatory strategy. Key responsibilities include the following and may vary based on job level and regional responsibility: 1. Input in development, post-approval and life cycle management · Participate in global regulatory team meetings as appropriate; · Advise the regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned; · Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area. 2. Liaison with Regulatory Agencies and Local Operating Companies · Act as back-up for contact with Regulatory Agencies as needed; · Draft cover letters for Regulatory Agency communication; · Assist in the preparation of meetings with Regulatory Agencies; · Liaise with LOCs, and ensure responses to queries are made in a in timely manner, and that content is consistent with the regulatory strategy. 3. Input in process development · Assist in development and improvement of processes related to regulatory submissions; 4. Clinical Trials · Review clinical trial plans and protocols and ensure alignment with regulatory requirements; 5. Health Authority Submissions (e.g. Briefing Books, Scientific advice packages, Marketing...
Employer Name: Technojobs
Job short description: Health services managers
Country: United Kingdom
Region: Berkshire, Buckinghamshire and Oxfordshire
Contract duration: Permanent
Contract type: Full time
Source of job offer:
Department for Work and Pensions, Public Employment Services, United Kingdom
How to apply: Other - see free text
Salary currency: GBP
Salary period: Monthly
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