Senior Manager, CMC-Regulatory
Location: Hertfordshire | Permanent Role
Are you an experienced regulatory affairs professional with deep expertise in Chemistry, Manufacturing, and Controls (CMC)? We’re looking for a Senior Manager to join a dynamic Medicine Development team supporting multiple projects from development through post-approval stages.
What you’ll do:
* Lead and manage CMC-regulatory activities across various development and marketed products, ensuring compliance and regulatory risk mitigation.
* Collaborate closely with cross-functional teams including Integrated Project Teams (IPTs) and CMC to drive license submissions and approvals.
* Develop and execute CMC-regulatory strategies and oversee the preparation of key regulatory documents, including Module 3 sections.
* Provide expert advice on CMC-regulatory issues and quality guidelines to stakeholders and project teams.
* Support growth market submissions and manage post-approval changes in liaison with affiliates and distributors.
* Continuously evaluate and improve CMC-regulatory processes to enhance efficiency and patient-centric approaches.
What we’re looking for:
* Proven track record in CMC-regulatory affairs within the pharmaceutical industry.
* Strong understanding of regulatory guidelines and quality standards related to drug substance and drug product development.
* Excellent leadership and stakeholder management skills, with the ability to handle multiple projects simultaneously.
* Experience working within cross-functional teams and navigating complex regulatory environments.
* Strategic mindset with a passion for innovation and patient-focused healthcare solutions.
Why join us?
You’ll be part of a collaborative environment where your regulatory expertise drives global success. The role is based at our facility in Hertfordshire, with all necessary IT and communication tools provided.
If you’re ready to take on a pivotal role in advancing medicines that make a difference, we want to hear from you.