Senior Manager, Global Regulatory Affairs CMC

Responsibilities

• - With some supervision, lead execution of regulatory Chemistry, Manufacturing & Controls (CMC) investigational, registration, and/or post-approval strategies for assigned products.
• - Serve as RA CMC delegate for the GRA CMC Product Lead across clinical development and commercial lifecycle.
• - Apply global RA CMC regulations and guidelines to enhance regulatory success and compliance.
• - Use precedents and regulatory intelligence to support robust, accurate submissions.
• - Plan, execute, and manage regulatory submissions per the strategy from GRA CMC Product/Device leads.
• - Define CMC content (data/documentation) requirements and review for conformance; anticipate future challenges.
• - Support CMC preparation for meetings with Health Authorities.
• - Interact with international Health Authorities on administrative procedural topics.
• - Evaluate change proposals for global regulatory impact; ensure and enhance regulatory compliance.
• - Communicate developments impacting regulatory success to stakeholders; exercise sound judgment and timely escalation.

• - BS/BA in a scientific discipline; advanced degree preferred.
• - 6+ years pharmaceutical Regulatory CMC or Device experience, including major variation/amendment leadership and/or support for initial IND/IMPD or initial NDA/BLA (equivalent industry experience considered).
• - Strong understanding of scientific principles and global regulatory CMC requirements (drug development and post-market support).
• - Proven ability to understand/communicate regulatory strategy; analytical attention to detail; assess alternative approaches.
• - Excellent written and oral communication; emerging leadership and teamwork; inclusive culture.

• - Medical, dental, vision, 401(k) with match, disability and life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, sick time, and paid vacation are mentioned.