Graduate Regulatory Scientist

Proclinical Staffing; Basingstoke; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading staffing agency in the United Kingdom seeks a Regional Regulatory Scientist to ensure compliance with regional requirements and support regulatory submissions. Responsibilities include collaborating with global regulatory leads, maintaining quality standards, and contributing to labelling strategies. The ideal candidate has a Bachelor’s degree in a scientific discipline and 1–3 years of industry experience with strong analytical and communication skills. This role offers an opportunity to impact regulatory practices significantly.

Qualifications

• 1–3 years of industry or relevant experience.
• Ability to work independently with attention to detail.
• Experience managing risk in a regulated environment.

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.
• Contribute to the development of local/regional labelling strategies.
• Interpret new guidelines and anticipate their impact.

Skills

Strong knowledge of local/regional regulatory procedures

Solid communication skills

Developing negotiation and influence skills

Strong analytical skills

Advanced teamwork skills

Education

Bachelor’s degree in a scientific or health sciences discipline

Job description

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.