Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) (Biologics)

Location: Hybrid schedule with 3 days in office at hirify.global headquarters in Lake County, Illinois; Irvine, California; or Waltham, Massachusetts, United States.

Salary: $109,500–$208,500 per year.

Company

hirify.global develops innovative medicines and solutions across immunology, oncology, neuroscience, and aesthetics.

What you will do

• Prepare CMC regulatory strategies and submissions for biologics, including INDs, CTAs, amendments, renewals, annual reports, supplements, and variations.
• Analyze regulatory information, legislation, regulations, and guidance to support regulatory decisions.
• Review and revise submission documents to clearly present data and strategy to regulatory agencies.
• Develop strategies for agency interactions and manage meeting requests and information packages.
• Manage product changes and change controls, including analysis and approval of manufacturing change records.
• Represent CMC Regulatory Affairs on product development, regulatory, operations, and R&D teams while providing strategic advice and mentoring colleagues.

Requirements

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering, or a related field.
• At least 6 years of experience in the biopharmaceutical or related industry.
• Experience working in a complex, matrixed environment.
• Strong written and verbal communication skills.
• Ability to work in a hybrid schedule with 3 days in an hirify.global office in Lake County, IL, Irvine, CA, or Waltham, MA.

Nice to have

• Advanced relevant degree.
• Certification.
• At least 6 years of biopharmaceutical Regulatory Affairs, R&D, or Operations experience, including 3 years in Regulatory Affairs.

Culture & Benefits

• Paid vacation, holidays, and sick leave.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) benefits for eligible employees.
• Eligibility to participate in long-term incentive programs.
• Opportunity to contribute to Regulatory Affairs CMC initiatives and mentor colleagues.