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 requirementsExcellent attention to detail with strong written and verbal communication skillsSkilled in managing multiple projects and working in cross-functional teamsProficient in regulatory systems such as eCTD Manager is mandatoryRegulatory Specialist // eCTD // ICH // MHRA // EMA // MAA // Life Cycle Maintenance // Labelling // CMC