Regulatory Affairs Specialists

1 day ago

Bishop's Stortford Hertfordshire, United Kingdom Scendea Full time

Are you looking to advance your career in regulatory affairs?

At Scendea, we deliver market-leading scientific expertise and regulatory solutions to advance healthcare innovation worldwide. We are dedicated to streamlining medicinal product development, reducing time-to-market, and minimising costs for our biotech and pharmaceutical clients. If you are experienced in regulatory affairs and passionate about providing strategic and technical solutions to complex product development challenges, we’d love to hear from you .

What’s involved?

You will play a critical role in providing regulatory guidance and innovative strategies across a wide range of medicinal product development activities. This includes:

  • Providing innovative drug development plans, data gap analyses and international regulatory strategies for complex products within the changing regulatory environment.
  • Contributing to technical authorship and review of development regulatory documents including Regulatory Strategy Plans, Clinical and Drug Development Plans, Clinical Trial Applications, Pre-INDs, INDs, Scientific Advice and Meeting Briefing Documents, Orphan Drug and Paediatric plans/applications, Protocols, Investigator Brochures, IMPDs, CSRs, Marketing Authorisation Applications, New Drug Applications, Biologic License Applications, according to area of expertise.
  • Representing clients in regulatory agency interactions and providing regulatory solutions to agency objections.
  • Collaborating across jurisdictions and disciplines to deliver expert consulting services .

What we are looking for:

  • A high scientific calibre with a life science focused BSc (or equivalent), and a higher degree in a biomedical field or equivalent (e.g., a life science focused MSc or preferably a PhD).
  • 8-10 years of drug development experience.
  • 8-10 years of experience with either FDA, MHRA, and/or EMA, including negotiation. Regulatory experience may include time within a National Competent Authority.
  • Direct experience preferred in providing strategic regulatory planning from early-stage development up to marketing authorisation, and a proven ability to define and deliver creative scientifically driven solutions to technical development and regulatory issues.
  • A UK resident with the right to work in the UK without the need for sponsorship either now or in the future.

Why Scendea?

As part of our team, you’ll work alongside industry-leading experts in a fast-paced, supportive environment. With a current team of over 50 staff based in the UK, Netherlands, Australia, and the US, Scendea is undergoing a period of significant growth, with the addition of new office locations and service lines to facilitate the delivery of expert and strategic global regulatory consulting services to our rapidly growing client base.

You will also receive;

  • A competitive salary.
  • Generous bonus program, which rewards success.
  • 26 days’ holiday plus public holidays, and discretionary additional days for birthday and work anniversary.
  • Employer pension contribution.
  • Provision of Private healthcare insurance.
  • Access to Employee Assistance Programme.
  • Employee Ownership Trust Scheme.
  • A challenging and stimulating position for a dynamic and competent scientist, looking to contribute to a growing business and a rapidly expanding team.
  • Coaching, mentoring and support of your continuous learning, and professional development within a highly recognised international team.

Register your interest today

We are always looking for talented individuals to join our global team. If this sounds like the next step in your career, click “Apply” to register your interest.

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