Exciting Opportunity: Manager, Regulatory Affairs – Lead the Way in Global Healthcare Innovation
Join a forward-thinking team dedicated to advancing life-changing medicines worldwide. As a Manager in Regulatory Affairs, you'll play a pivotal role in shaping and executing strategies that bring innovative therapies to patients. This is your chance to be at the forefront of regulatory excellence, managing medium-complexity programs across key markets while working in a flexible, primarily remote environment.
What You Will Do
* Develop and implement regulatory strategies for assigned products, aligning local requirements with global standards.
* Lead regulatory submissions and lifecycle management activities to ensure timely approvals and ongoing compliance.
* Act as the key liaison with regulatory agencies, preparing for and participating in agency interactions.
* Collaborate with cross-functional teams worldwide to drive regulatory excellence and facilitate product development.
* Monitor evolving legislation and regulatory environments, providing insights that influence strategic decisions.
* Support and mentor local teams and external vendors, ensuring adherence to quality and compliance standards.
* Contribute to global regulatory strategies, supporting product registration, lifecycle maintenance, and innovative development pathways.
Required Skills
* Strong knowledge of regulatory principles, procedures, and policies related to medicinal products.
* Proven experience managing regulatory submissions, labels, and compliance activities.
* Excellent communication, negotiation, and influencing skills.
* Ability to analyze scientific and clinical data and communicate complex information clearly.
* Demonstrated teamwork and collaboration skills across diverse cultural and functional teams.
* Sound understanding of national legislation, registration challenges, and lifecycle management processes.
Nice To Have Skills
* Experience working with global health authorities such as EMA or other regulatory agencies.
* Knowledge of pediatric, orphan drug, or expedited development pathways.
* Ability to engage in complex negotiation and conflict resolution scenarios.
* Familiarity with healthcare compliance and pharmacovigilance activities.
* Multilingual skills or experience working across multiple regions.
Preferred Education And Experience
* Doctorate or Master’s degree in a scientific field with at least 3 years of relevant experience, or
* Bachelor’s degree with a minimum of 5 years of directly related regulatory experience.
Other Requirements
* Willingness to travel on-site approximately once per month to Uxbridge.
* Ability to work remotely, maintaining productivity and collaboration across global teams.
* Strong organizational skills and attention to detail.
* Relevant certifications or memberships in regulatory affairs organizations are a plus.
If you're passionate about making a tangible impact on global health through regulatory excellence, we want to hear from you. Take the next step in your career and apply today to join a vibrant team committed to innovation and patient well-being.
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