Position Overview

An opportunity has arisen for an experienced Regulatory Affairs professional with deep expertise in CMC for biologics. This senior-level role is ideal for candidates who combine scientific excellence with strategic regulatory insight and a track record of leadership within the biologics sector. The position involves shaping regulatory strategies, overseeing submissions, and guiding complex product development from early-stage through to post-marketing, across a diverse range of biological modalities.

Key Responsibilities

Develop and implement regulatory strategies for CMC aspects of biological products, considering both UK and international requirements.
Conduct data gap analyses and create innovative development plans for new and existing biologics.
Prepare, review, and submit high-quality CMC documentation for regulatory filings, including CTAs, INDs, IMPDs, MAAs, BLAs, and more.
Lead cross-functional teams on multi-country regulatory projects, ensuring timely delivery and compliance with all relevant guidelines.
Represent the organisation in interactions with regulatory authorities, managing responses to queries and providing solutions to regulatory challenges.
Mentor and provide technical leadership to colleagues, supporting their professional development and fostering a culture of scientific excellence.
Stay abreast of evolving regulatory landscapes (FDA, EMA, MHRA, ICH, etc.) and advise on compliance strategies for a range of biological product types, such as monoclonal antibodies, vaccines, biosimilars, cell and gene therapies, and recombinant proteins.
Support internal knowledge-sharing and training initiatives related to regulatory affairs and CMC topics.

Candidate Profile

Advanced degree (MSc, PhD, or equivalent) in life sciences, biomedical, or related field.
5–10 years of hands-on experience in CMC regulatory affairs, with a focus on biologics.
Demonstrated expertise in regulatory strategy development and CMC documentation for a variety of biological products.
In-depth understanding of UK, EU, and US regulatory frameworks and guidelines for biologics.
Experience leading regulatory submissions and managing post-approval/lifecycle activities.
Excellent communication skills, with the ability to convey complex scientific and regulatory concepts to diverse audiences.
Proven leadership and mentoring abilities, with experience guiding teams and supporting professional development.
Strong organisational and project management skills, with meticulous attention to detail.
Willingness to travel occasionally within the UK and internationally as required.
Full right to work and reside in the UK.