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Senior Regulatory Affairs Manager

2 months ago

Surrey, United Kingdom RApport Global Strategic Services Ltd Full time

Find your place and use your experience to make an impact.

We are RApport-ELIQUENT A specialist international regulatory consultancy, bringing cutting-edge and life-changing medicines and medical devices to global markets.

The RApport-ELIQUENT team continues to grow from strength to strength, with the team applying our latest thinking in creating the next generation of regulatory solutions that deliver value to some of the largest organisations in our industry. We help our clients to solve their regulatory challenges by developing bespoke solutions that meet their unique needs.

Our team operates at a global level. There is plenty to learn, space to develop and make a real contribution with an opportunity to participate in a wide range of engagements.

The Opportunity

Senior Regulatory Affairs Manager

We are currently looking for a Senior Regulatory Affairs Manager, with a focus on CMC to join our expanding team. You will be responsible for CMC regulatory matters for our clients' senior management and operational teams within the UK, Europe, and internationally.

What you'll do

As a Senior Regulatory Affairs Manager, you will lead, manage, and provide regulatory CMC expertise, but you will also be experienced in developing and implementing regulatory strategies in multiple regions and agency interactions. Key responsibilities you can expect to accomplish include:

  • Work independently on client projects while collaborating with the team and communicating with directors.
  • Conduct line management responsibilities, including performance reviews. Engage in matrix management across diverse teams as required.
  • Advise and develop regional and CMC considerations in regulatory strategies, ensuring clear definition and implementation in collaboration with relevant regional stakeholders.
  • Implement regulatory and CMC strategies for products, regulatory affairs processes, and activity planning in compliance with national legislation and regulatory requirements.
  • Provide regulatory CMC expertise to cross-functional project teams to ensure alignment of development activities with overall regulatory CMC strategies.
  • Review and author CMC documents for both small and large molecules.
  • Manage regulatory CMC aspects of submissions and post approval change controls.
  • Conduct research and horizon-scanning activities to support regulatory strategy documents.

    About you

    The Senior Regulatory Affairs Manager will lead, manage, and provide guidance to a wide range of regulatory disciplines. Qualified candidates must meet a set of criteria we deem essential for those interested in the Senior Regulatory Affairs Manager role:
    • Bachelor's degree in a relevant field (e.g. Life Sciences or Pharmacy).
    • Extensive experience as a senior CMC regulatory professional with extensive experience with CMC requirements, including authoring CMC regulatory documentation. Line management experience and ability to deliver internal and external training.
    • Ability to interact and communicate effectively and proactively with clients and teams.
    • Familiar with European and US regulatory requirements and pathways to registration, including early access pathways.
    • Experience with biological products or cell and gene therapies is ideal but not essential.
    • Experience with European and/or US regulatory procedures and requirements is preferred.
    • Excellent organisational skills and time management.
    • Ability to manage multiple projects and multiple tasks in balance, to work in a matrix environment, and to an agreed-upon schedule.

      Our commitment to you

      A career at RApport-ELIQUENT is an opportunity to hone your skills and develop in the direction you choose. Join us and you'll experience a purpose you can believe in and an impact you can see.

      We're committed to building a culture that empowers all of our people to thrive and feel a sense of belonging at RApport-ELIQUENT. We invest in outstanding people, building a team of future thinkers from diverse backgrounds, empowering them to achieve their potential.

      What makes RApport-ELIQUENT a great place to work?

      We will empower you to choose the working pattern that works best for you and how you work best, to be collaborative, learn from the team, share your experience and insight, build relationships that drive your career and prioritise your wellbeing. We offer an environment where you can experience a purpose you believe in, the freedom to bring your true self to work every day, growing and developing at a pace that's right for you.

      We believe it's only when you're comfortable and at your best that you can make the greatest impact on those around you.

      Please note while this roles offers remote working, we are ideally looking for individuals who are based in the UK, as our office is located in Surrey.