Manager, Regulatory Affairs

📋 Description

• Manage the advertising and promotional submissions (2253s) related to the BLA and serve as the RA
• Provide expertise in translating local, regional, and international regulatory requirements into
• Manage the preparation, review, and submission of regulatory documents across all modules
• Collaborate on submission content with contributing authors across functional areas to achieve
• Ensure timely preparation of organized and scientifically valid applications.
• Interact with regulatory agencies on defined matters.

🎯 Requirements

• Bachelor's degree & 5+ years' directly related experience.
• Direct experience in promotional material review and knowledge of FDA OPDP requirements.
• Bachelor's degree in Chemistry, Biology, Pharmaceutical Science or a related field (preferred).
• Minimum 5-7 years' experience in pharmaceutical Regulatory Affairs with a focus on drugs/biologics
• Regulatory Affairs certification or equivalent training (preferred).
• Experience in preparation, submission, and lifecycle management of investigational/marketing

🎁 Benefits

• Competitive Compensation including base salary and annual performance bonus.
• Flexible PTO, holidays, and parental leave.
• Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance