Senior Manager, Regulatory Affairs

Summary

Join Ocular Therapeutix, a biopharmaceutical company, as a Regulatory Affairs professional. This remote position requires a Bachelor’s degree and 3+ years of experience in regulatory affairs, including IND submissions, FDA regulatory affairs, drug development, and compliance. You will assist in preparing and compiling domestic and international product submissions (PMAs, 510ks, etc.), agency registrations, and regulatory information for inspections. Responsibilities include supporting corrective actions, adverse event reporting, responding to Health Authority inquiries, and developing/submitting global CTAs. You will also review product documentation, maintain regulatory procedures, and coordinate annual reports. Additional responsibilities include supporting product labeling and advertising review and providing regulatory research.

Requirements

• Must have a Bachelor’s degree in Regulatory Affairs, Pharmaceutical/Health/Life science or related field plus three (3) years of experience with regulatory affairs
• Experience must include three (3) years each of the following: preparing and leading IND submissions in the pharmaceutical industry for FDA; US FDA regulatory affairs; drug development process for human use and regulatory requirements of FDA and OUS; compliance with regulatory guidance documents, identifying regulatory scientific data needs, and solving regulatory issues
• Experience may be gained concurrently

Responsibilities

• Assist in the preparation and compilation of domestic and international product submissions, with guidance. This may include, but is not limited to: PMAs, 510ks, international dossiers and/or CE technical files; INDs, NDAs, MAAs, NDS and global CTAs
• Responsible for agency establishment registrations and device/drug listings
• Assist with the preparation and compilation of regulatory information requested during regulatory inspections
• Support domestic and international field corrective actions and adverse event reporting, when necessary
• Assist in response to Health Authority inquiries
• Assist in the development and submission of any necessary global CTAs, maintain global CTAs throughout development lifecycle for pharmaceutical products
• Review product and process documentation for assigned projects to ensure compliance with regulatory dossiers
• Assist in the development and maintenance of regulatory procedures to assure consistent, efficient and compliant regulatory processes
• Coordinate development and submission of annual Developmental Safety Update Reports
• Support in the review and approval of product labelling and advertising
• Provide regulatory research information as requested