Regulatory Affairs & Compliance Specialist

Role Overview We are seeking a Regulatory Affairs & Compliance professional to support global regulatory activities with a focus on Europe and Rest of World (RoW) markets in a biotech environment. This role is execution‑focused and writing‑intensive, with primary responsibilities in regulatory documentation, compliance support, and coordination with internal stakeholders. The ideal candidate has a knowledge of regulatory affairs, cGMP and quality systems, and strong technical writing skills. Key Responsibilitie sRegulatory Affairs (EU & RoW Focus )Prepare, compile, and maintain regulatory documentation for submissions, variations, renewals, and regulatory correspondence (e.g., MAAs, variations, responses to health authority questions) .Support global regulatory activities for Europe and other international markets in collaboration with local affiliates or partners .Ensure regulatory documents are accurate, consistent, and aligned with current regional requirements .Assist in tracking regulatory activities and compliance‑related deliverables .Regulatory Writing & Documentatio nAuthor and/or review regulatory sections and supporting documents .Support the preparation of responses to health authority questions, deficiency letters, or requests .Maintain regulatory files and supporting documentation in accordance with internal procedures and applicable regulatory requirements .Compliance Suppor tSupport compliance activities, including regulatory compliance with quality and manufacturing information .Collaborate with Quality and Manufacturing teams to ensure regulatory filings reflect processes and are compliant .Author, support authoring, and review of quality documents, with a focus in risk assessment .Cross‑Functional Collaboratio nWork closely with internal stakeholders to collect, review, and integrate required information into regulatory documents .Coordinate timelines and deliverables for assigned regulatory activities .Required Qualifications :Bachelor’s degree in Life Sciences or related discipline (advanced degree is a plus) .3 years of experience in Regulatory Affairs within biotech, pharmaceutical, or related regulated industries .Working knowledge of European regulatory requirements and cGMP concepts .Strong regulatory writing skills with experience authoring or compiling regulatory documents .Strong communication skills, particularly in written English .