Position Overview

A senior opportunity is available for a highly experienced Regulatory Affairs professional with a strong background in CMC for small molecule pharmaceuticals. This role is focused exclusively on the development, regulatory strategy, and lifecycle management of small molecule drug products, covering all aspects from early development through to commercialisation. The position is ideal for individuals with proven expertise in small molecule CMC, including process development, scale-up, regulatory submissions, and post-approval changes.

Key Responsibilities

Develop and implement regulatory strategies specifically for small molecule drug products, ensuring compliance with UK, EU, and global requirements.
Lead the preparation, review, and submission of CMC documentation for small molecule regulatory filings, including CTAs, INDs, IMPDs, NDAs, MAAs, and DMFs.
Oversee process development, manufacturing scale-up, and lifecycle management for small molecule active pharmaceutical ingredients (APIs) and finished dosage forms.
Conduct data gap analyses and design innovative development plans for new and existing small molecule products.
Represent the organisation in interactions with regulatory authorities, managing responses to queries and providing solutions to small molecule CMC challenges.
Mentor and provide technical leadership to colleagues, fostering professional growth and maintaining scientific excellence in small molecule CMC.
Stay current with evolving regulatory landscapes (FDA, EMA, MHRA, ICH, GMP) and advise on compliance strategies for a variety of small molecule dosage forms, including NCEs and generics.
Support internal knowledge-sharing and training initiatives related to small molecule regulatory affairs and CMC topics.

Candidate Profile

Advanced degree (MSc, PhD, or equivalent) in chemistry, pharmacy, pharmaceutical sciences, or a related field.
Minimum 10 years of hands-on experience in CMC regulatory affairs for small molecule pharmaceuticals, including process development, manufacturing, and regulatory compliance.
Demonstrated expertise in preparing and submitting CMC documentation for a range of small molecule dosage forms and regulatory pathways.
Strong understanding of UK, EU, and US regulatory frameworks and guidelines for small molecules, including FDA, EMA, ICH, and GMP regulations.
Proven ability to lead regulatory submissions and manage post-approval/lifecycle activities for small molecule drug products.
Excellent communication and presentation skills, with the ability to convey complex scientific and regulatory concepts to diverse audiences.
Leadership and mentoring experience, with a track record of 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.