Manager, Regulatory Affairs

Join Bio Space as a Manager, Regulatory Affairs in a growing biopharmaceutical company dedicated to treating immunodeficient patients.

Supervises the planning, preparation, and evaluation of regulatory documents submitted to U.S. regulatory agencies. Acts as the primary liaison with agencies, contractors, and cross‑functional teams to ensure compliance with corporate policies and regulatory requirements.

• Provides accurate, timely regulatory guidance to all company functions.
• Prepares, reviews, presents, and evaluates all regulatory submissions across the product lifecycle (pre‑application, IND/BLA/OD, maintenance, post‑marketing).
• Determines regulatory strategy, defines submission requirements, and coordinates data collection from internal and external stakeholders.
• Plans regulatory milestones, sets timelines, and assures timely, accurate, and complete submissions.
• Develops and maintains project timelines, milestone/submission tracking systems, and document archive systems.
• Conducts regulatory risk assessments and recommends mitigation strategies.
• Oversees deviation reporting and product recall procedures.
• Stays current on new laws/regulations, assesses impact, and implements appropriate internal changes.
• Serves on project teams to provide regulatory guidance for investigational and marketed products.

• Minimum 7 years of practical regulatory expertise across all drug development phases.
• Minimum 5 years’ experience and a Master’s degree.

• Bachelor’s degree in Pharmaceutical, Biological, or Chemical Science or related field.
• Advanced degree desirable.

• Excellent written and verbal communication and negotiation skills.
• Knowledge of GMP, GCP, GLP, and GDPP.
• Strong program management and problem‑solving skills.
• Proficiency in Microsoft Office, Excel, and project management software.
• Detailed knowledge of U.S. Federal food, drug, and cosmetic regulations, FDA guidance, and international harmonization standards.
• Experience balancing multiple projects with tight deadlines.

• Ensure compliance with all quality policies, SOPs, and regulatory documentation practices.
• Escalate any compliance issues to QA, HR, or EH&S as appropriate.

• 401(k) plan with employer match.
• Medical, Vision, Life, and Dental insurance.
• Pet insurance and company‑paid STD/LTD.
• 3 weeks paid time off (first year).
• Tuition assistance after the first year.
• Company‑paid holidays.

ADMA Biologics is an Equal Opportunity Employer.