Regulatory Affairs Manager (CMC)

Job Description:

Responsibilities

• Generate and execute of global and country-specific regulatory strategies
• Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments
• Develop global dossiers for CMC content for initial submissions, variations and amendments
• Support change management activities
• Develop response strategy and respond to health authority questions
• Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans
• Liaise with local regulatory teams to align on filing strategy
• Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system
• Follow established department regulatory processes to ensure cross-product alignment 

Qualification & Expeirence

• CMC- specific regulatory knowledge & experience
• Education & Experience (Basic)
• Bachelor’s degree and 8-13 years of directly related experience
• Experience in manufacture, testing (QC/QA or clinical), or distribution
• Regulatory CMC experience