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 Responsibilities

Regulatory 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 & Documentation

• Author 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 Support

• Support 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 Collaboration

• Work 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.