Senior Professional RA CMC
- Dublin
- Permanent
- Full-time
Location: Dublin D12 E923, Ireland, Ireland
Contract type: Permanent
Job ID: 3312Role DescriptionSenior Professional RA CMCWe 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 RoleYour 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.
- 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