What are the responsibilities and job description for the Regulatory Attorney for Biologics Review position at Axogen?
Axogen is committed to creating a work environment that fosters professional growth and development. Our team members are passionate about making a difference in the lives of patients and caregivers.
About Us:
We value unique perspectives and believe in creating a friendly, open, and fun team culture. Our comprehensive benefits package includes health insurance, dental insurance, vision insurance, matching 401(k), paid time off, holidays, flexible spending accounts, tuition reimbursement, paid parental leave, paid caregiver leave, basic life insurance, supplemental life insurance, employee stock purchase plan, and disability insurance.
Responsibilities:
- Provide timely, legal review and advice during Medical, Legal, Regulatory/Pharmaceutical Review Committee to ensure Axogen's promotional activities comply with FDA Regulations, industry guidelines and company policies.
- Review promotional materials for biological product, including social media, scientific exchange, healthcare professional, patient support, and consumer-directed advertising.
Requirements:
- J.D. from ABA accredited law school.
- Minimum 10 years of legal expertise supporting biological and med device product review. Experience with biologics review is required; medical device product experience is a plus.
