Senior Manager, Regulatory Affairs CMC - Remote

Overview

The Senior Manager, Regulatory Affairs CMC is responsible for supporting and executing Regulatory CMC strategies in collaboration with cross-functional teams. This role manages CMC-related global regulatory submissions and Health Authority interactions to meet the project timelines for the assigned projects.

In Short

• Support development and implementation of Regulatory CMC strategies.
• Review and author CTD CMC sections for global submissions.
• Prepare responses to Health Authority CMC questions.
• Coordinate with CMC team to ensure timely submission of documents.
• Collaborate with cross-functional teams on regulatory impact assessments.
• Contribute to regulatory risk assessment and mitigation activities.
• Develop internal Regulatory CMC guidance and instructions.
• Provide Regulatory CMC review for clinical protocols.

Requirements

• Bachelor’s degree in scientific disciplines; MS/PhD preferred.
• 5+ years of pharmaceutical or biopharmaceutical regulatory CMC experience.
• Experience in preparing CMC modules for CTA, NDA/MAA submissions.
• Expertise in ICH and US/EU regulatory requirements.
• Experience with EU regulatory CMC requirements and GMP regulation.
• Authoring experience for complex technical documents.
• Experience with Veeva system preferred.
• Excellent communication skills with attention to detail.
• Strong project management skills.
• Ability to demonstrate core values of accountability and collaboration.

Benefits

• Competitive wages and benefits package.
• Medical, dental, vision coverage.
• Time off and retirement plan.
• Other voluntary benefits for employees.