Closing on: Jun 30, 2024

Location: Surrey/Remote

Salary: £40,000 – £55,000

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 Officer

We are currently looking for a Senior Regulatory Affairs Officer to join our expanding team. You will be responsible for a wide range of regulatory activities, bringing existing experience and ensuring high quality standards and nurturing enduring partnerships.

What you’ll do

As a Senior Regulatory Affairs Officer, you’ll join and lead teams supporting our clients and partnering with them to drive action and impact. Every day is different, but key responsibilities you can expect to accomplish include:

  • Review all types of variations, both simple and complex.
  • Conduct gap analysis reports for dossiers including CMC, non-clinical and clinical sections as required and with appropriate support.
  • Co-ordinate licensing and post-licensing procedures on behalf of clients, such as Clinical Trial Applications, National, Mutual Recognition and Centralised Applications under senior staff guidance.
  • Plan and manage regulatory submissions.
  • Review updates to Summary of Product Characteristics and Patient Information Leaflets.
  • Review labelling texts for clients, including checking of mock-ups.
  • Review and draft sections of regulatory dossiers and co-coordinating those procedures through to approvals through EU, US or other agreed regions.
  • Coordinate and support QC activities related to all submissions.
  • Research activities to support regulatory strategy documents, horizon-scanning activities.

About you

Senior Regulatory Affairs Officer are pivotal to our clients’ and teams’ success, as well as to our success as a firm. Qualified candidates must meet a set of criteria we deem essential for those interested in the Senior Regulatory Affairs Officer role:

  • Bachelor’s degree in a relevant field (e.g., Life Sciences or Pharmacy)
  • Demonstrated experience in regulatory affairs.
  • Excellent consulting skills including analytical thinking and problem-solving skills.
  • Highly motivated, energetic, enthusiastic, committed, and inclusive team player.
  • Ability to exercise business judgement, communicate persuasively and generate insights to build trusting client relationships.
  • 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 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.

Job Category: regulatory affairs
Job Type: Full Time
Job Location: Surrey/ Remote

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