Senior Manager, Global Regulatory Affairs, CMC (Biologics)

Location: California, United States — Remote/Home-Based. The listed compensation and benefits apply to US-based candidates only.

Salary: $140,000–$210,000 base pay annually, with potential bonus, equity, and benefits.

Company

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

What you will do

• Manage the preparation and review of Module 2 and 3 CMC sections for global regulatory submissions covering biological products.
• Develop CMC regulatory strategies for commercial and development programs with multidisciplinary teams.
• Assess regulatory risks, communicate strategy options, and support Global Regulatory Team objectives.
• Coordinate responses to health authorities and manage submission timelines.
• Represent CMC regulatory activities in meetings with business partners and regulatory agencies.
• Maintain regulatory compliance, product information, change controls, impact assessments, and electronic publishing activities.

Requirements

• Regulatory CMC experience supporting biological products and drug lifecycle activities.
• Experience preparing electronic Common Technical Document CMC materials, including MAAs, BLAs, variations, responses, CTAs, and INDs.
• Working knowledge of FDA, EMA, and ICH guidelines.
• BSc or BA degree with regulatory CMC or related experience.
• Strong written and verbal English communication skills.
• Ability to work independently, within multidisciplinary teams, and with external partners and regulators.

Culture & Benefits

• Remote/home-based work arrangement in California.
• Medical, dental, and vision insurance.
• 401(k) retirement savings plan.
• Flexible paid vacation.
• Potential annual cash bonus or incentive compensation and discretionary equity grants.