Senior Manager, Regulatory Affairs CMC (Biotech)

Location: Wilmington, Delaware, United States. Domestic travel of up to 10% may be required.

Company

hirify.global is a global biopharmaceutical company developing and commercializing proprietary therapeutics for unmet medical needs across Hematology, Oncology, Inflammation, and Autoimmunity.

What you will do

• Manage regulatory CMC strategies and submission activities for small-molecule and biologic development programs.
• Support products from early development through Phase 3, registration, and post-approval stages.
• Lead or participate in meetings with the FDA and other global health authorities, and prepare regulatory records of interactions.
• Review CMC data packages and ensure submissions are complete, consistent, high quality, and compliant with current standards.
• Coordinate responses to CMC regulatory questions with internal CMC experts and oversee post-approval changes, supplements, and variations.
• Communicate regulatory CMC guidance and strategy to internal and external stakeholders.

Requirements

• In-depth knowledge of pharmaceutical development and CMC regulations and guidelines for pharmaceutical or biotechnology products.
• Relevant experience in regulatory affairs CMC or a related pharmaceutical development field.
• Experience with global clinical trial and marketing applications, eCTD submissions, and electronic document management systems.
• A degree in a relevant field is required; equivalent experience may be considered.
• Willingness to travel domestically up to 10%.

Nice to have

• Experience with regulatory CMC aspects of both large- and small-molecule drugs.
• Advanced degree in a scientific, Regulatory Affairs, or related pharmaceutical field.

Culture & Benefits

• Opportunities to participate in professional development meetings and conferences.
• Reasonable travel accommodations are provided for individuals with disabilities.
• Commitment to a diverse and equal-opportunity workplace.