Key Responsibilities:

• Planning and preparing strategies for post-approval activities like variations, renewals, market expansions, and annual reports.
• Evaluating change controls and providing regulatory insights on quality changes in production and quality control.
• Reviewing study reports (including process validation, stability studies, and analytical method validation) from quality control and production to ensure everything meets regulatory standards.
• Working with teams across manufacturing, supply chain, quality control, quality assurance, and other regulatory departments to coordinate submission preparation.
• Writing or reviewing submission content to make sure it aligns with regulatory requirements (for variations and health authority questions).
• Managing projects within the client's Regulatory Information Management systems (handling worldwide submissions).
• Identifying, escalating, and managing risks related to regulatory procedures and activities.

What We’re Looking For:

Competencies & Skills

• Strong understanding of CMC and post-approval regulatory requirements.
• Knowledge of regulatory processes, systems, and guidelines (like quality control, stability, process validation, and comparability studies).
• Excellent written and spoken English.
• Proficiency in a local language (depending on location: French, Italian, or German).
• Understanding of biological processes and Qualification/Validation principles.

Qualifications & Experience

• University degree (preferably in Life Sciences) or equivalent experience.
• Proficient in Word, PowerPoint, Excel; familiarity with Veeva Vault is a plus.
• Fluent in English and depending on location, French, German, or Italian.
• Experience in regulatory affairs (especially in technical/CMC/quality) within the pharmaceutical industry.
•  Experience writing CMC (technical) sections for regulatory documents (registration files or variations).
• Experience in validation, Quality Assurance, or production, with experience preparing regulatory documents.

Soft Skills

• Good at managing your time to meet deadlines.
• Clear communicator, especially in a multicultural and
• multidisciplinary setting.
• Strong writing and analytical skills, with a keen attention to detail.
  Creative, critical thinker.
• Team player, flexible, well-organized, and accountable.