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Senior Regulatory Affairs Manager

Sanofi-aventis Groupe, Reading

Senior Regulatory Affairs Manager

Salary not available. View on company website.

Sanofi-aventis Groupe, Reading

  • Full time
  • Permanent
  • Onsite working

Posted today, 6 Nov | Get your application in now to be one of the first to apply.

Closing date: Closing date not specified

Job ref: add203b63b2c43f09c6fced24de81ce0

Location ref: Reading

Full Job Description

  • Lead the preparation, submission and follow-up of regulatory applications to UK and Irish health authorities, so that vaccine approvals are secured and kept up to date
  • Own the regulatory strategy for new approvals and ongoing changes, including support for product launches and the long-term management of the vaccine range
  • Lead the yearly seasonal flu vaccine update process, making sure UK and Irish submissions are on time and the vaccine supply stays compliant each season
  • Make sure all information sent to regulators is accurate, clearly presented and delivered on schedule
  • Build strong working relationships with the vaccines business and global regulatory colleagues, aligning regulatory plans with business priorities
  • Advise on how products are positioned and promoted, and contribute to commercial and operational planning from a regulatory angle
  • Coach, develop and manage a small team, setting clear priorities and supporting their growth, while also covering for the Head of Regulatory Affairs when needed

    Minimum experience: 8-10+ years in regulatory affairs overall, including at least 3-5 years in a people-leadership capacity.
  • Proven hands-on experience in UK regulatory affairs for biologics, including managing the lifecycle of a product portfolio (for example variations, renewals and submissions through national and European routes)
  • A track record of leading and developing a team, with the ability to coach, motivate and set clear priorities
  • Sound judgement in handling manufacturing and supply changes, balancing regulatory compliance with business needs
  • Strong stakeholder management and communication, with the confidence to influence health authorities, business partners and cross-functional colleagues
  • A life science or chemistry degree, or equivalent practical experience in a related field
  • Fluent English, both written and spoken, as accurate communication is critical for regulatory submissions

    As Senior Regulatory Affairs Manager within our UK & Ireland Regulatory Affairs team, you'll lead regulatory strategy and submissions for our vaccines portfolio, managing the MHRA and HPRA lifecycle of marketing authorisations, leading the annual seasonal strain change process, and partnering with the Vaccines business and Global Regulatory Affairs to shape launches and registration plans, while leading and developing a small team. Ready to get started?
    • Join the engine of Sanofi's mission - where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions. About Sanofi We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

  • Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
  • Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
  • Help improve the lives of millions of people globally by making drug development quicker and more effective.
  • Enjoy opportunities to collaborate beyond your area of expertise, working with diverse teams across science, clinical, and digital fields to spark new ideas and drive breakthroughs.
  • Accelerate your professional development with structured career paths designed for both scientific and leadership advancement. Grow in ways you never imagined through bold moves that stretch your potential, cross moves into other business areas, and short-term gigs that build your scientific expertise.
  • Join a workplace where diversity, equity, and inclusion are at the core, with Employee Resource Groups and leadership programs that celebrate every voice.
  • Achieve genuine work-life balance in a supportive R&D environment.
  • Enjoy outstanding benefits, including flexible working options, comprehensive healthcare, and well-being programs designed to help you thrive.
    • We are proud to be a Disability Confident Employer, committed to offering interviews to candidates who request consideration under the Scheme and meet the minimum requirements for this role.

Direct job link

https://www.jobs24.co.uk/job/senior-regulatory-affairs-manager-127699564
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