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Senior Regulatory Affairs Executive

Senior Regulatory Affairs Executive

Posted 31 August by Pfizer
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Company Profile:

A career at Pfizer offers opportunity, ownership and impact!

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer is a global leader in the biopharmaceutical industry and we are always looking for new colleagues to support our mission

Job Role:

Senior Regulatory Affairs Executive UK & Ireland

Head Office based

Part Time - 18.5 hours

Job Description:

Primary Responsibilities:

  • Use regulatory expertise to contribute to regulatory strategies and plans that achieve business goals

  • Provide regulatory advice and information to meet customer and cross-divisional colleague requests

  • Manage and submit Marketing Authorisation Applications, at times creating the necessary technical data to support country submissions and reviewing and approving proposed regulated documents (SPC, PIL and Labelling) and associated artwork in line with regulations

  • Manage and submit MA Variation and MA Renewal Applications in line with the relevant regulatory requirements

  • Management of Safety Reports and issues with regulatory authorities

  • Proactively take opportunities to develop or enhance working relationships with Regulatory Authorities and trade associations to negotiate optimal outcomes for the business on product issues

  • Manage Clinical Trial Approvals from preparing agreed submission documentation through to other maintenance activities for the lifecycle of the CTA

  • Populate and maintain regulatory databases including ad hoc and routine quality checking

  • Obtain authority approvals for supply of unlicensed medicines (Named Patient/Compassionate Use)

  • Safeguard compliance and manage packaging and prescribing information component updates

  • Implement MA Divestments, Cancellations and product Discontinuations, advising wider team on relevant regulatory activities

  • Lead cross functional meetings to explore options to help minimise or mitigate interruptions to the supply chain and notify relevant Ministry of Health and Regulatory Authorities.

  • Support Regulatory Affairs Group Development towards Pfizer WSR Vision and Values

  • Support regulatory activities for the development and maintenance of medical devices, including acting as EU Authorised Representative if required

Person Specification:

Technical Skill Requirements

  • Computer literacy

  • Excellent written and verbal communication skills

  • Proven strength in analytical thinking

Qualifications (i.e., preferred education, experience, attributes)

  • Life sciences or chemistry graduate to honours level or equivalent

  • Masters Degree, Post Graduate Diploma or PhD preferred

  • Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory Affairs)

  • Previous experience and proven track record in Regulatory Affairs (Human Medicinal Products)

  • Member of The Organisation for Professionals in Regulatory Affairs (TOPRA) preferred

Reference: 35995057

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