Responsibilities
- Lead and develop the local Regulatory Affairs team, setting clear goals, managing performance, and supporting training, mentoring, and resource planning.
- Prepare, review, and adapt CMC documentation using validated systems; monitor regulatory changes and assess impact across markets.
- Ensure alignment between registered dossiers and site operations; support GMP compliance, review regulated content, and assist during audits and inspections.
- Act as primary liaison with regulatory authorities managing communication, submissions, and responses.
- Collaborate cross-functionally with Quality, Supply Chain, R&D, and Commercial teams to provide regulatory guidance and support operational goals.
- Maintain and improve departmental SOPs, contribute to continuous improvement initiatives, and ensure regulatory processes reflect current standards.
Requirements
- A degree in Pharmaceuticals or related field
- At least 5+ years experience in a similar position
Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
...
