Regulatory Affairs Specialist/Regulatory Scientist - FSP

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Regulatory Affairs Scientist – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to support Regional and/or Global Regulatory Leads in developing and executing regulatory strategies for assigned programs. As a Regulatory Affairs Scientist, you’ll contribute to global and regional programs across development and post-approval maintenance, helping ensure regulatory activities and submissions are aligned with applicable requirements and the overall regulatory strategy.

You’ll work collaboratively with Regulatory Leads, subject matter experts and cross-functional teams, contributing to regulatory submissions, Health Authority interactions, risk assessment and regulatory planning while developing your expertise across the global regulatory environment.

What You’ll Do:

Support the Regulatory Lead in the development and execution of integrated global and/or regional regulatory strategies for assigned programs across development and post-approval maintenance.

Contribute to the compilation of regulatory documents for submission to Health Authorities.

Support submissions including iPSPs/PIPs, ODDs, Briefing Books, INDs/CTAs, BLA/MAAs and sBLA/Variations.

Lead or support collaboration with subject matter experts to provide timely responses to Regulatory Agency queries, ensuring content remains consistent with the agreed regulatory strategy.

Develop your understanding of the regulatory environment, competitor intelligence and therapeutic area landscape, and apply these insights to the development of regulatory strategies.

Identify and assess regulatory risks associated with specific strategies and contribute to defining appropriate mitigation strategies.

Act as a backup or delegate for the Regulatory Lead within project teams or workstreams, helping maintain alignment and a consistent “one regulatory voice.”

As applicable, review clinical trial plans, protocols and submission plans for assigned projects to ensure alignment with regulatory requirements.

Provide regulatory input and follow-up relating to inspections, audits, litigation support and product complaints.

Support the development and continuous improvement of processes related to regulatory submissions.

Education and Experience Requirements:

University degree in a scientific or biomedical field.

Minimum 3 years’ experience in a clinical development environment, preferably within Regulatory Affairs.

Knowledge, Skills and Abilities:

Independent and able to learn quickly.

Highly self-motivated with a hands-on approach.

Excellent interpersonal skills, with the ability to build effective relationships across a diverse range of stakeholders.

Strong leadership and critical-thinking skills, with the ability to work collaboratively to solve problems and make decisions.

Sound judgement and the ability to analyse situations and information, making decisions based on facts and evidence.

Demonstrated leadership within the context of assigned responsibilities.

Able to communicate effectively within teams, with guidance and support from management.

Excellent organisational skills and strong attention to detail.

Able to prioritise effectively within a fast-paced environment.

Proactive and collaborative, with the ability to drive assignments forward across teams.

Working knowledge of current global clinical trial regulations .

Able to summarise content for focused and maintenance submissions and provide training to others on submissions.

Flexible mindset, with the resilience to adapt to changing priorities and regulatory strategies.

Able to travel based on business needs.