Senior Manager Regulatory Affairs

This range is provided by i-Pharm Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Position: Senior Manager, Global Regulatory Affairs

About the Role:

We are seeking a highly skilled and motivated Senior Manager to join our Global Regulatory team. This role is pivotal in defining regulatory strategies, leading submissions, and ensuring compliance for innovative therapies that address some of the world’s most challenging diseases. You will act as a regional regulatory lead, guiding cross‑functional teams and serving as a key contact for regulatory authorities.

What You’ll Do:

• Represent regional Regulatory Affairs or serve as Regional Lead on cross‑functional teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers, and/or cross‑regional Regulatory Submission Teams).
• Proactively identify regulatory or related risks/issues and develop mitigation and/or contingency plans.
• Lead the preparation, compilation, and timely filing of complex regulatory submissions, requiring cross‑functional interactions for commercial or investigational product(s) for assigned territories in line with ICH requirements, regional requirements, and company policies and procedures.
• Define and implement regulatory strategies for assigned products, compounds, or projects.
• Lead regulatory submissions and ensure timely, compliant filings across multiple regions.
• Represent Regulatory Affairs on cross‑functional teams and liaise with health authorities.
• Oversee and coach less experienced colleagues, fostering growth and capability development.
• Drive process improvements and contribute to special projects that enhance regulatory operations.
• Ensure product labelling and packaging compliance with global standards and regional requirements.

What We’re Looking For:

• Extensive background in Regulatory Affairs or related industry roles.
• Proven success in setting regulatory strategy and leading submissions for medicinal products.
• Strong knowledge of ICH guidelines, EU centralized procedures, and global regulatory trends.
• Experience with clinical trial applications/amendments and post‑approval variations.
• Excellent communication, analytical thinking, and project management skills.
• Ability to lead cross‑functional teams and influence without direct authority.
• Flexible, adaptable, and capable of managing multiple priorities in a matrixed environment.
• Experience within Virology advantageous.

Why Join Us?

You’ll be part of a global team dedicated to advancing therapies that make a real difference. This is your chance to lead, innovate, and contribute to improving health outcomes worldwide.

Ready to take the next step? Apply now and help us deliver regulatory excellence that transforms lives.

Seniority level: Mid‑Senior level

Employment type: Full‑time

Job function: Research and Science

Industries: Pharmaceutical Manufacturing and Biotechnology Research