Senior Professional RA CMC

Join to apply for the Senior Professional RA CMC role at LEO Pharma UK/IE

4 days ago Be among the first 25 applicants

Join to apply for the Senior Professional RA CMC role at LEO Pharma UK/IE

Get AI-powered advice on this job and more exclusive features.

Application deadline: 16.07.2025

Location: Dublin D12 E923, Ireland, Ireland

Contract type: Permanent

Job ID: 3312

Role Description

Senior Professional RA CMC

We invite you to join our Global CMC Regulatory team in Dublin or Gdansk as a Senior Specialist RA CMC, where you will shape the global regulatory CMC strategy for a biological drug product. Build 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:

• Develop, plan and execute Regulatory CMC Strategies for post-approval changes to a recently authorized biological drug product as an active member of a multi-disciplinary team. Identify and communicate potential risks associated with strategy scenarios. Facilitate fast approvals of submissions whilst minimising regulatory risks and maximising post-approval flexibility.
• Provide regulatory leadership on CMC matters in cross-functional teams, using your expertise in CMC and regulatory insight.
• Support roll out strategies for licenses in additional markets for a drug device combination product.
• Support EU, US and Rest of World commercial license maintenance activities (including drug substance and drug product tech transfers).
• Coordinate the preparation and timely submission of submissions and responses to Regulatory Agencies on CMC drug product aspects (relevant M1 and M2; M3 sections). Lead the project management of CMC changes in collaboration with cross-functional stakeholders - manage timelines to ensure timely approvals and ensure development objectives are met.
• Act as regulatory CMC representative at internal meetings, as well as support at meetings with business partners and Health Authorities 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).
• Oversee the regulatory authoring and review process for CMC dossiers.
• Assess regulatory impact of Change Control cases for LEO and external sites.
• Manage Health Authority interactions for assigned products.
• Communicate effectively to guide and influence within work group / function regarding life-cycle management processes.
  
  

Your Qualifications

To excel in this role, you will need:

• A scientific educational background in pharmacy, pharmaceutics, chemical engineering, biopharmaceutics, biomedicine or equivalent.
• Minimum 5 years' experience in Regulatory Affairs in either a pharmaceutical or biotech setting.
• 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/ BLAs; 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
  
  

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.

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.Seniority level

• Seniority levelNot Applicable

Employment type

• Employment typeFull-time

Job function

• Job functionInformation Technology
• IndustriesPharmaceutical Manufacturing

Referrals increase your chances of interviewing at LEO Pharma UK/IE by 2x

Sign in to set job alerts for "Senior" roles.

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr

---