Regulatory Affairs Specialist III, Advertising and Promotion

Quality, regulatory and pharmacovigilance groups work across every site. Granitekeep Therapeutics is a global biopharmaceutical company with medicines approved in more than 60 countries.

We have an immediate opening for a Regulatory Affairs Specialist III, Advertising and Promotion in New York City. This position focuses on CMC sections for IND amendments and an upcoming NDA. This is a fully remote position open to candidates anywhere in the US.

Essential duties and responsibilities

• Keep regulatory files and correspondence organized and inspection ready
• Participate in FDA inspections and notified body audits
• Review labeling, IFUs and promotional materials for regulatory compliance and supported claims
• Track submission timelines and commitments in Veeva Vault RIM or a similar system
• Coordinate with international distributors on country registrations

What you'll need

• 6+ years of regulatory affairs experience in medical devices, pharma or biologics
• Bachelor's degree in a life science, engineering or pharmacy
• Working knowledge of 21 CFR Parts 11, 210/211 and 820 and relevant FDA guidance
• Clear technical writing and careful editing
• Hands-on experience preparing at least one FDA submission
• Comfortable managing several submissions and deadlines at once

Preferred

• EU MDR or IVDR transition experience
• Master's degree or PharmD

Schedule: Remote within US time zones, with quarterly travel to headquarters

Pay and benefits

Pay: $157,000 - $188,000 a year

• Medical, dental and vision insurance
• 401(k) with 4% match
• Three weeks of PTO to start
• Cell phone reimbursement

Granitekeep Therapeutics is an Equal Opportunity Employer, including disability and protected veteran status.

Start: Within 30 days.

Demo job created on 11jobs for testing and demonstrations. It is not an actual opening at Granitekeep Therapeutics.