Regulatory Affairs Specialist

Walker Cole is looking for a Regulatory Affairs Specialist to join a leading UK Pharmaceutical Manufacturer based in Hertfordshire. This present the chance to be a part of a supportive community focused on growth and development. This is an exciting opportunity for exposure and to build your career.

As a Regulatory Affairs Specialist, you will:

• Prepare and submit regulatory documents (MAAs, variations) to health authorities for product approvals and lifecycle maintenance.
• Monitor and interpret regulatory changes to ensure company-wide compliance.
• Develop and implement regulatory strategies in collaboration with cross-functional teams.
• Review and approve labelling and packaging to meet regulatory standards.
• Manage post-marketing activities, including variations, updates, and pharmacovigilance support.
• Apply CMC knowledge to support stability studies, shelf-life claims, and regulatory documentation.
• Act as the main point of contact with regulatory agencies, handling queries and submissions.
• Collaborate with QA, QC, and Manufacturing teams to maintain compliance across the product lifecycle.
• Maintain up-to-date regulatory intelligence to guide strategic decision-making.

A Regulatory Affairs Specialist will need:

• Degree in Pharmacy, Life Sciences, Regulatory Affairs, or related field (advanced degree preferred)
• Strong knowledge of MHRA, EMA, and ICH regulatory requirements
• Excellent attention to detail with strong written and verbal communication skills
• Skilled in managing multiple projects and working in cross-functional teams
• Proficient in regulatory systems such as eCTD Manager is mandatory

Regulatory Specialist // eCTD // ICH // MHRA // EMA // MAA // Life Cycle Maintenance // Labelling // CMC