Director, Drug & Device Combo – Autoinjector/Inhalation Reg.-CMC

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Oversee regulatory affairs strategies for the development of autoinjectors, inhalation devices, and other delivery systems.

• Assist the drug-led CMC Product Team with designated products, ensuring all assigned regulatory activities are completed successfully.

• Manage the creation and evaluation of technical content for autoinjectors (and other devices)/integral combination product documentation, which includes IND/CTA submissions, original NDA/MAA filings, agency background materials, post-approval submissions/variations, and responses to inquiries from health authorities, following established business processes and systems.

• Identify, communicate, and escalate potential issues to the Regulatory CMC Product Lead and the Device Quality & Regulatory Affairs Leadership team.

• Utilize knowledge of regulatory affairs to benefit the company, ensuring the approval, launch, and continuous market supply of our human medicinal products globally.

⛳️ Requirements

• Bachelor's degree in a biological science, engineering, or a related field (advanced degree is preferred).

• A minimum of 10 years of relevant experience, which includes biological/pharmaceutical research, manufacturing, testing, or regulatory CMC; candidates with a Bachelor’s degree should have at least this level of experience, while those with a Master’s degree require a minimum of 5 years, and candidates with a Ph.D. should have comparable experience.

• Expertise in the regulatory development and manufacturing of combination products.

• Experience with IDE/IND/510(k) clearances, CE mark authorizations, NDA/BLA submissions, and post-approval processes in medical devices or combination products.

• Strong understanding and comprehensive knowledge of the design controls process.

🏝️ Benefits

• Comprehensive medical, dental, vision healthcare, and additional insurance benefits for employees and their families.

• Retirement savings options, including a 401(k) plan.

• Paid holidays.

• Vacation time.

• Compassionate leave and sick days.