Graduate Regulatory Scientist

6 days ago

Basingstoke, Hampshire, United Kingdom Proclinical Staffing Full time £40,000 - £80,000 per year

Purpose

We are seeking a Regional Regulatory Scientist to provide expertise in supporting high‑quality and efficient regulatory submissions, approvals, and local labelling for assigned products. This role will play a key part in ensuring compliance with regional requirements and supporting interactions with regulators.

Key Responsibilities

  • Provide input and review of global strategic and submission plans for assigned products.
  • Support regional regulatory leads in governance committees and regulator meetings.
  • Ensure timely approval and delivery of local regulatory submissions, engaging cross‑functional partners.
  • Contribute to the development of local/regional labelling strategies, applying competitor knowledge and regulatory precedent.
  • Maintain compliance with applicable regulations and internal quality systems.
  • Interpret new guidelines and anticipate their impact, initiating change where needed.
  • Own regulatory activities for marketed products in the assigned region.
  • For US support: contribute to promotional claims development and advise on promotional strategy.
  • For EMEA support: ensure registration needs for local patients in clinical trials are met.

Leadership & Collaboration

  • Partner with global regulatory leads to resolve development and registration issues.
  • Liaise with affiliates to anticipate region‑specific challenges, including labelling impacts on promotion, pricing, and reimbursement.
  • Participate in regional and cross‑functional meetings to align regulatory strategies.
  • Drive continuous improvement projects to simplify processes and increase productivity.
  • Represent regulatory functions on cross‑functional initiatives.
  • Foster an inclusive environment that encourages open discussion and robust decision‑making.

Qualifications

  • Bachelor's degree in a scientific or health sciences discipline.
  • 1–3 years of industry or relevant experience.
  • Strong knowledge of local/regional regulatory procedures and drug development processes.
  • Solid communication skills (written, spoken, presentation).
  • Ability to work independently with attention to detail.
  • Developing negotiation and influence skills.
  • Strong analytical skills and ability to manage risk in a regulated environment.
  • Advanced teamwork skills, embracing diversity, equity, and inclusion.

Additional Information

  • Key contacts include project team members, global regulatory leads, regional marketing/medical, and affiliate representatives.

Please apply on Linkedin.

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