Sr. Manager Regulatory Affairs

• Oversees deliverables for CMC strategy and submissions for an assigned portfolio of products at varying stages of development,

• Works with external stakeholders including regulatory agencies and influential professional bodies, and seeks to influence regulatory policy globally

• Identifies regulatory risks across products within the defined scope, communicates these risks, and ensures aligned plans for mitigation

• Provides coaching, mentoring, and supports development of junior CMC Regulatory Affairs staff

• Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments

• 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
• May manage staff

Knowledge and Skills

Regulatory CMC- specific regulatory knowledge & experience

Staff management and development

Education & Experience (Basic)

Doctorate degree
OR
Masters degree and 3 years of directly related experience
OR
Bachelors degree and 5 years of directly related experience
OR
Associates degree and10 years of directly related experience
OR
High school diploma GED and12 years of directly related experience

Education & Experience (Preferred)

Experience in manufacture, testing (QC/QA or clinical), or distribution

Regulatory CMC experience