Regulatory Affairs Specialist (CMC)

CMC regulatory affairs role focused on FDA submissions, eCTD filings, post-approval lifecycle management, CMC change strategy, and pharmaceutical regulatory compliance. Job Requirements Bachelor's degree in a scientific field 5+ years of regulatory experience Experience with FDA submissions Experience with eCTD filings Experience with CMC changes Experience supporting post-approval lifecycle management for pharmaceutical products Experience with document management systems Microsoft Office proficiency Ability to travel up to 10% Preferred Skills Regulatory Affairs Certification (RAC) Experience with NDAs Experience with ANDAs Experience with DMFs Experience authoring post-approval supplements Experience reviewing and updating product labeling Knowledge of FDA regulatory requirements Knowledge of EU regulatory requirements Knowledge of Health Canada regulatory requirements Knowledge of TGA regulatory requirements Knowledge of cGMP requirements Experience maintaining regulatory databases Experience mentoring junior regulatory team members Job Responsibilities Support

U.S. FDA

regulatory submissions for pharmaceutical products Plan, author, compile, and submit eCTD regulatory filings for marketed products Support NDA, ANDA, and DMF submissions Evaluate CMC changes and develop regulatory strategies for post-approval submissions Lead CMC regulatory activities on cross-functional teams when appropriate Author and submit post-approval supplements Review and update product labeling in accordance with regulations Ensure alignment with FDA and global regulatory requirements Identify regulatory risks and recommend mitigation strategies Maintain regulatory databases and documentation systems Review submission documents for accuracy and compliance Manage multiple regulatory projects and priorities Interpret complex regulatory issues and provide recommendations Monitor evolving regulatory guidelines and industry standards Support electronic document management systems Mentor and guide junior regulatory team members Coordinate with cross-functional teams to support project completion and regulatory alignment

Pay Details:

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for

Employers San Francisco Fair Chance Ordinance Massachusetts Candidates Only:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.