Senior Manager, Global Regulatory Affairs, CMC (Biologics)

Location: California, United States — Remote/Home-Based; compensation information is for US-based candidates only

Base pay: $140,000–$210,000 per year, plus potential bonus, incentive compensation, equity, and benefits.

Company

hirify.global is a global biopharmaceutical company developing and commercializing medicines for serious diseases, with a portfolio spanning sleep disorders, epilepsy, oncology, and neuroscience.

What you will do

• Manage registration and CMC regulatory support for commercial and development programs involving biological products.
• Prepare and review CTD Modules 2 and 3 for INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents.
• Support global CMC regulatory strategies for commercial products and early- and late-stage development programs.
• Assess and communicate regulatory risks, coordinate agency responses, and manage submission timelines.
• Represent CMC regulatory affairs in meetings with business partners and regulatory agencies.
• Maintain regulatory compliance, product information, change-control documentation, impact assessments, and electronic submission publishing.

Requirements

• Bachelor’s degree in science, regulatory affairs, or a related field, with relevant regulatory CMC experience.
• Strong knowledge of CMC regulatory requirements and the drug lifecycle, preferably for biological products.
• Experience preparing electronic Common Technical Document CMC submissions, including MAAs, BLAs, variations, responses, CTAs, and INDs.
• Understanding of FDA, EMA, and ICH regulations and guidelines.
• Strong written and verbal English communication skills.
• Ability to work independently, collaborate with multidisciplinary teams, and engage with external partners and regulators.

Culture & Benefits

• Work in a science-driven, patient-focused global biopharmaceutical environment.
• Medical, dental, and vision insurance.
• 401(k) retirement savings plan.
• Flexible paid vacation.
• Potential eligibility for annual cash bonus or incentive compensation and long-term equity grants.