Senior Regulatory Affairs Specialist

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

Role overview

We are replacing a colleague who is moving away. We need a Senior Regulatory Affairs Specialist who can assemble submission-ready documents and work through FDA questions without hand-holding. This position focuses on CMC sections for IND amendments and an upcoming NDA. This is a hybrid role. Most of the team is in the New York City office Tuesday to Thursday.

Day to day

File MDRs and support complaint and recall decisions with quality. Maintain establishment registrations and device listings. Support EU MDR technical documentation and notified body reviews. Write and compile Module 3 CMC sections in eCTD format. Coordinate with international distributors on country registrations.

Required qualifications

5+ years of regulatory affairs experience in medical devices, pharma or biologics. Hands-on experience preparing at least one FDA submission. Familiarity with eCTD structure and submission publishing tools. Comfortable managing several submissions and deadlines at once. Knowledge of ISO 13485 and ISO 14971 for device roles.

Preferred qualifications

Software as a medical device (SaMD) and cybersecurity submissions. Prior FDA pre-submission meeting experience. EU MDR or IVDR transition experience. Master's degree or PharmD.

$144,000 - $186,000 a year

Benefits

Health savings account (HSA) with employer contribution. 401(k) with 4% match. Paid holidays.

Granitekeep Therapeutics provides equal employment opportunities to all employees and applicants.

We are unable to sponsor visas for this position.

Most hires start within two to three weeks of an offer.

Start: Immediately.

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