CMC Regulatory Strategy Lead — Global Submissions

Freyr Solutions; Wilmington (DE); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Freyr Solutions is seeking an experienced CMC Regulatory Affairs Consultant to support our client with global regulatory strategy and submission activities across large molecules, small molecules, and drug-device combination products.

The ideal candidate will bring hands-on expertise in developing CMC regulatory strategies, preparing and reviewing global regulatory submissions, managing Health Authority interactions, and providing strategic regulatory guidance to cross-functional stakeholders

Qualifications

• Bachelor's degree or higher in a scientific discipline.
• Hands-on experience in CMC Regulatory Affairs within pharma/biotech.
• Experience with IND, NDA, BLA, and/or MAA submissions.
• Regulatory submissions strategy and roadmaps development.
• Experience with Health Authority interactions and responses.

Responsibilities

• Develop and execute CMC regulatory submission strategies and roadmaps.
• Provide strategic regulatory consultation to cross-functional teams.
• Prepare, review, and submit Pre-IND, IND, NDA, and BLA meeting requests and briefing packages.
• Submit NDAs, BLAs, MAAs, and other regulatory applications to Health Authorities.
• Manage interactions with global Health Authorities and respond to information requests.
• Coordinate responses to Health Authority queries and lifecycle management submissions.
• Support regulatory activities for drug-device combination products.
• Ensure timely completion of regulatory dossiers and responses.

Skills

CMC Regulatory Affairs

Regulatory strategy

Health Authority interactions

Regulatory submissions

Stakeholder management

Education

Bachelor's degree or higher in Pharmacy, Chemistry, Biology, Life Sciences, Pharmaceutical Sciences, or a related scientific discipline

Job description

Freyr Solutions is seeking an experienced CMC Regulatory Affairs Consultant to support our client with global regulatory strategy and submission activities across large molecules, small molecules, and drug-device combination products.

The ideal candidate will bring hands-on expertise in developing CMC regulatory strategies, preparing and reviewing global regulatory submissions, managing Health Authority interactions, and providing strategic regulatory guidance to cross-functional stakeholders