Senior Technical Regulatory Affairs Manager - Biotech

About the Role

We are seeking a Senior Technical Regulatory Affairs Manager to join our dynamic team at Idorsia Pharmaceuticals. This role offers an exciting opportunity to work remotely while contributing to the advancement of innovative therapies in the biotech sector. As a Senior Technical Regulatory Affairs Manager, you will play a critical role in ensuring regulatory compliance and facilitating the approval of our cutting-edge products.

What You'll Do

• Write, update, and maintain the Module 2 (Quality Overall Summary) and Module 3 (Quality) of CTDs for global marketing applications.
• Prepare and manage the Quality part of the IMPD, IND, and other technical regulatory documents for global clinical trials.
• Develop Briefing Books and supportive documentation for Health Authority meetings including pre-IND and pre-NDA.
• Respond to quality questions raised by Health Authorities following submissions of global Marketing/Clinical Trial Applications.
• Negotiate and coordinate strategies with internal and external stakeholders to ensure successful regulatory submissions.
• Assess and communicate the regulatory impact of product changes and ensure compliance with ICH guidelines and GMP requirements.
• Organize reviews and consolidate technical documents for global regulatory submissions.
• Store and track regulatory documents within relevant document management systems.

Requirements

• A university degree (MSc, PhD) in Pharmacy, Chemistry, Biology, or a related technical/science field.
• At least 5 years of experience in the technical/CMC regulatory field or similar positions within the pharmaceutical industry.
• Strong organizational and communication skills, with the ability to manage multiple tasks and complex projects.
• Proficiency in MS Office, Veeva, and DocuBridge.
• Excellent written and spoken English; knowledge of additional European languages is a plus.
• In-depth understanding of ICH guidelines, GMP requirements, and regulatory procedures across various health authorities.
• Advanced knowledge of drug substance and product development, manufacturing processes, and quality control.

Nice to Have

• Experience with regulatory submissions in multiple regions including US-FDA, EU-CHMP, and others.
• Familiarity with document management systems and regulatory tracking tools.

What We Offer

• Competitive salary and benefits package.
• Flexible remote work options.
• Opportunities for professional development and career advancement.
• A diverse and inclusive work environment.
• Engagement in meaningful work that impacts patient health.

At Idorsia, we value diversity and encourage all qualified candidates to apply. We are committed to fostering an inclusive workplace where everyone can thrive. If you are passionate about regulatory affairs and want to make a difference in the biotech industry, we would love to hear from you!