Senior Regulatory Affairs Manager, Chemistry Manufacturing and Controls

This is a fully remote position, open to applicants in United States.

📋 Description

• Offer strategic regulatory input related to CMC for designated projects and products.

• Develop or contribute to submission strategy documents that outline variation types, supporting data, and necessary submission materials.

• Review and authorize published submission outputs.

• Assist project teams during the planning phase to ensure the collection and submission of relevant data and details for all markets.

• Review, compose, and revise CMC submission documents and sections of the dossier.

• Keep registration tracking information updated and adhere to high standards of document management practices.

• Collaborate with global and regional Regulatory Affairs teams to respond to queries from regulatory authorities.

• Provide regulatory guidance and evaluate the impact of key brand CMC variations on product dossiers.

• Counsel project teams on matters related to CMC regulations.

• Assist Quality Assurance during audits and inspections.

• Remain informed about current CMC-related guidelines.

⛳️ Requirements

• Bachelor’s Degree with a minimum of 6 years of relevant experience.

• Background in the diagnostic, pharmaceutical, or medical device sectors.

• Capability to prioritize, plan, and assess deliverables against established strategic objectives.

• Proven experience in a highly-regulated setting.

• Strong analytical skills within a CMC regulatory context.

• Knowledge and expertise in pharmaceutical sciences, chemistry, and analytical sciences.

• Familiarity with electronic document management systems and quality management systems.

• Understanding of international CMC regulatory requirements.

• Experience in pharmaceutical CMC regulatory or quality assurance environments, particularly with injectable diagnostic or pharmaceutical products.

• Experience in a matrix organizational structure.

• Proficient in using Veeva RIM or similar registration tracking tools.

• Excellent problem-solving and negotiation capabilities.

• Must be legally authorized to work in the United States; GE HealthCare will not sponsor employment visas.

• Successful completion of a drug screening, if applicable.

🏝️ Benefits

• Performance-based incentive compensation that may include cash bonuses and/or long-term incentives (LTI).

• Comprehensive medical, dental, and vision insurance.

• Paid time off.

• 401(k) plan with opportunities for employee and company contributions.

• Life, disability, and accident insurance.

• Tuition reimbursement.

• Opportunities for professional development.

• Relocation assistance is not provided.