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