Regulatory Affairs Project Manager

ROLE OVERVIEW

An exciting opportunity for a Regulatory Affairs Project Manager to join our client, a leading organisation within the pharmaceutical, biotechnology and life sciences sector.

This role will lead and coordinate regulatory projects across the product lifecycle, working closely with Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC), Quality, Clinical, Nonclinical and Pharmacovigilance specialists. You will ensure high-quality regulatory deliverables are completed on time, within scope and in line with global regulatory requirements.

KEY DUTIES AND RESPONSIBILITIES

Your duties as the Regulatory Affairs Project Manager will be varied however the key duties and responsibilities are as follows:

• Lead and manage multiple regulatory projects, ensuring delivery against agreed timelines, budgets and quality expectations.
• Develop and maintain project plans, risk registers and resource allocations, while identifying risks and implementing appropriate mitigation strategies.
• Coordinate cross-functional teams and facilitate project governance meetings, providing clear progress updates to internal and external stakeholders.
• Support global regulatory activities including new product development, agency interactions, renewals, variations, lifecycle management and Marketing Authorisation Applications, including oversight of CTD module content.
• As the Regulatory Affairs Project Manager you will act as the primary contact for assigned clients and stakeholders, managing expectations and contributing to the continuous improvement of regulatory project management processes.

ROLE REQUIREMENTS

To be successful in your application to this exciting role as the Regulatory Affairs Project Manager we are looking to identify the following on your profile and past history:

• A Degree or higher level in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology or a related life sciences discipline.
• Proven project management experience within pharmaceutical, biotechnology, life sciences or a related regulated environment, alongside a strong understanding of Regulatory Affairs.
• Knowledge of Chemistry, Manufacturing and Controls (CMC), regulatory strategies, submission pathways and product lifecycle activities.
• Excellent communication, stakeholder management and organisational skills, with the ability to coordinate cross-functional teams and deliver clear project updates.

WHAT’S IN IT FOR YOU?

• The opportunity to lead varied regulatory projects across the pharmaceutical product lifecycle while working with multidisciplinary teams and external stakeholders.
• A role offering valuable exposure to global regulatory activities, CMC-related programmes and the development of effective project management methodologies and best practices.

Key Words: Regulatory Affairs Project Manager / Regulatory Project Management / CMC / Pharmaceutical / Biotechnology / Life Sciences / CTD / Regulatory Submissions / Lifecycle Management / Stakeholder Management / Project Governance / Global Regulatory Activities

"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career"

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.