Global CMC Regulatory Strategist for Medical Dermatology
2 weeks ago
About LEO Pharma
">We are a global leader in medical dermatology, dedicated to making a lasting impact beyond the skin. Our innovative approach sets us apart, and we are committed to helping people achieve healthy skin through innovative treatments.
">Role Overview
">In this role, you will provide strategic global regulatory CMC support and advice to assigned products, working closely with cross-functional stakeholders to ensure alignment across Global Safety and Regulatory Affairs (GSRA).
">Your Key Responsibilities
">- ">
- Supporting commercial license maintenance activities, including post-approval variations, and collaborating on roll-out strategies for licenses in additional markets.">
- Leading the project management of CMC changes, coordinating the preparation and timely submission of submissions and responses to Regulatory Agencies on CMC aspects.">
- Representing the company as a regulatory CMC expert at internal meetings and external meetings with business partners and Regulatory Agencies.">
- Working with the Global Regulatory Team (GRT) to develop and implement regulatory strategies, ensuring alignment across all functions.">
- Identifying and addressing potential risks associated with strategy scenarios, collaborating with stakeholders to mitigate these risks.">
Requirements
">To succeed in this role, you should have:
">- ">
- A scientific educational background in a relevant field, such as pharmacy, pharmaceutics, chemical engineering, or biomedicine.">
- At least 5 years of experience in Regulatory Affairs.">
- Strong understanding of the drug development process and life cycle management.">
- Expertise in global CMC guidelines and regulatory requirements.">
- Experience with CMC regulatory documents, including M1, M2.3, and M3 for MAAs/NDAs.">
- Excellent communication and interpersonal skills, with the ability to build strong relationships.">
- Ability to work independently and collaboratively, with a strong attention to detail.">
- Fluency in verbal and written English.">
- Self-motivation and a passion for delivering results.">
Your Opportunity to Grow
">By joining our team, you will have opportunities to grow and develop your career, working with a dynamic and supportive team of professionals who share your passion for making a difference in the world of pharmaceuticals.
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