Regulatory Affairs Specialist (CMC)
Round Lake, IL
Req ID 51411BR
Business Title
Regulatory Affairs Specialist (CMC)
Business
Medical Products
Sub-Business
Regulatory Affairs
Country
US
State/Province
Illinois
Location of Position
Round Lake, IL
Shift_
1st
Job Description
Responsible for defining global chemistry, manufacturing and control (CMC) regulatory strategies and owning the CMC sections of regulatory submissions for drug products in the Medical Products Division.
•Supports Pre-Market CMC
•Supports Global Regulatory Leads (New Product Development)
•Participate on Global Regulatory Teams
•Participate/Lead CMC Focused Sub-Teams
•Owns CTD Module 3 and DMFs
•Primary Contact with R&D Technical Staff (CMC areas)
•Defines Global CMC Strategies
•Facilitate/Contribute to Baxter's Policy and Positions on CMC Standards
•Regulatory liaison with manufacturing plants and quality
•Quality support with inspections and agency meetings
•CMC Due Diligence
•Participates in External CMC Forums/Trade Associations
Job Requirements
•Sound basis of Regulatory knowledge
•Scientific Knowledge
•Ability to manage complex projects and timelines in a matrix team environment
•Strong oral and written communication and presentation skills
•Demonstrated interpersonal skills including strong negotiation skills
•Ability to independently identify compliance risks and escalate when necessary
•Ability to lead and coach others
•Technical and computer system skills (e.g. word processing, spreadsheets, databases, online research, electronic document management systems). Bachelor's degree or country equivalent in related scientific discipline with a minimum of 5 years regulatory experience in RA or related field. CMC experience supporting liquids for inhalation and development of container closure systems will be advantages.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
