Senior CMC Regulatory Specialist

Are you an experienced regulatory professional with a strong knowledge of global CMC guidelines? Do you thrive in a dynamic environment where your expertise can drive collaboration and support global regulatory initiatives? At LEO Pharma, we are committed to helping people achieve healthy skin through innovative treatments. We invite you to join our Regulatory team in Gdansk, where you will provide strategic global regulatory CMC support and advice to assigned product.

Shape the LEO Pharma of tomorrow.  

At LEO Pharma, our mission transcends the conventional. We're on an ambitious path to become the leaders in medical dermatology worldwide. If you're ready to make a difference, this role is your gateway to a world of opportunities!

Your Role

Your key responsibilities will include:

• Participate and support as an active member of a multi-disciplinary team to establish Regulatory CMC Strategies for post-approval changes to recently authorized commercial product. Identify and communicate potential risks associated with strategy scenarios.
• Support EU, US and Rest of World commercial license maintenance activities including post-approval variations; support roll out strategies for licenses in additional markets. 
• Coordinate the preparation and timely submission of submissions and responses to Regulatory Agencies on CMC aspects (relevant M1 and M2; M3 sections). Lead the project management of CMC changes in collaboration with cross-functional stakeholders - manage timelines to ensure approves and timely and development objectives are met. 
• Act as regulatory CMC representative at internal meetings, as well as support at meetings with business partners and Regulatory Agencies for CMC related issues. 
• Work with the Global Regulatory Team (GRT) to implement strategies and the Regulatory Project Plan, ensuring alignment across Global Safety and Regulatory Affairs (GSRA).
• Inform the RA CMC GRT lead about any unexpected regulatory CMC issues or risks and work 
• Use your knowledge of CMC information and regulatory requirements to contribute to development team discussions and documentation for submissions.
• Guide discussions on regulatory CMC matters in cross-functional teams, using your expertise in CMC information and regulatory insights.
• Oversee the regulatory authoring and review process for CMC dossiers.
• Ensure CMC information in dossiers allows for post-approval planning.
• Ensure continued regulatory compliance of products by independent evaluation of Change Control cases.
• Contribute to the Product Quality Review.
• Manage Health Authority interactions for assigned products.
• Participate in cross-functional teams for continuous improvement.

Your Qualifications

To excel in this role, you will need:

• A scientific educational background in pharmacy, pharmaceutics, chemical engineer, biomedicine or equivalent.
• Min 5 years’ experience in Regulatory Affairs.
• Proficient understanding of the drug development and LCM of products 
• Profound knowledge of global CMC guidelines (ICH, FDA, EMA etc) and strategic application of same.
• Must have experience with CMC regulatory documents (M1, M2.3, M3 for MAAs/ NDAs; variations, responses)
• Project management experience. 
• Excellent communication and interpersonal skills and ability to build strong relationships.
• Ability to work independently, willingness to voice opinions in the group environment, proactiveness and attention to details. 
• Proficient in verbal and written English.
• Self-motivated.

Your New Team

You will join an experienced and highly motivated team of CMC Regulatory Specialists located internationally (Denmark, Ireland & Spain) who are committed to a learning culture and supporting team members in achieving both business goals and personal development goals. 

Contact and Application

Ready to take the next step in your career? Apply now to join LEO Pharma. We look forward to receiving your application!

At LEO Pharma, we believe in the power of teamwork and the potential of every individual. Join us and be part of a company that is making a real difference in the world of pharmaceuticals. Apply today and seize this incredible opportunity to build new areas in a land full of possibilities.

You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest.