- Are you passionate about shaping regulatory strategy for life-changing therapies?
- Do you thrive in a fast-paced environment where your expertise drives global health outcomes?
- Are you ready to lead complex regulatory submissions and influence cross-functional teams?
If your answer is yes, this opportunity could be perfect for you.
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:
- Represents regional Regulatory Affairs or may serve as Regional Lead on cross-functional teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers and/or cross-regional Regulatory Submission Teams.
- Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plans.
- Leads the preparation, compilation, and timely filing of complex regulatory submissions, which require cross-functional interactions for commercial or investigational product(s) for assigned territories in line with ICH requirements, regional requirements and scientific 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.
