Regulatory Affairs Specialist

Responsibilities

• Draft and manage CMC sections for DMFs and customer dossiers (e.g., IND, NDA, BLA, MAA, CTD), including post-approval changes and annual reports.
• Prepare Module II (CTD Summaries) and Module III (Quality) content, covering manufacturing processes, control strategies, specifications, and validation data.
• Collaborate cross-functionally with customers, development managers, QA, and publishers to gather accurate technical data and align timelines.
• Advise customers on filing strategies and guide them in addressing specific queries from health authorities.
• Stay current with CMC regulations (e.g., ICH Q8‑Q11, FDA, EMA) and advise project teams on regional compliance implications.
• Ensure document quality and compliance by maintaining version control, formatting to eCTD standards, and assessing proposed changes for impact on existing filings.
• Manage department tracking, including regulatory overview sheets and financial tracking of RA activities.
• Mentor junior writers and licensing personnel on CMC best practices, and contribute to internal workshops and SOP development.

Requirements

• Master's degree in a relevant field is required; a PhD is preferred.
• Experiences (> 3 years) working with CMC sections for IND/NDA/BLA/MAA submissions, preferably within a pharmaceutical or biotech company.
• Certification in regulatory writing (e.g., RAPS, DIA) or formal training in regulatory affairs.
• Experience using Veeva Vault and other document management systems.
• Strong understanding of drug substance and drug product development, manufacturing processes, analytical testing, stability, and validation. Familiarity with biologics and / or small molecule CMC considerations is preferred.
• Excellent scientific writing, editing, and proofreading abilities; ability to translate complex technical data into clear, concise regulatory narrative.
• Proficient with ICH Q8‑Q11, FDA CMC guidance, EMA CTD guidelines, and other major agency requirements.
• Demonstrated meticulousness in document review, data verification, and compliance checking.
• Strong communication skills and highly organized.
• Pro-active and flexible team player.
• About Lonza
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Benefits

Additional Information

Regulatory Affairs Specialist Location : Oss The Regulatory Affairs (RA) Specialist within the Development & Manufacturing department, ADS Licensing, is responsible for the preparation, review, and maintenance of high-quality regulatory submission documents describing the chemistry, manufacturing, and controls (CMC) aspects of GlycoConnect® and other ADS Licensing components throughout their lifecycle. Working closely with customers and cross-functional teams-including development, manufacturing, quality, clinical, and regulatory strategy - the RA Specialist ensures a consistent and phase appropriate filing strategy. The RA Specialist further assures that all CMC information complies with global regulatory requirements (FDA, EMA, PMDA, MFDS, sFDA, Health Canada, etc.) and supports timely DMF and other filing approvals, post-approval commitments, and life cycle management activities. What you will get: An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. A variety of benefits dependent on role and location. The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits . The full-time annual base pay for this position in The Netherlands is expected to range between 53.250 EUR and 74.550 EUR. Initial salary placement within this range will be determined based on role‑related factors such as experience, qualifications, and expected contribution.

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