Sr Manager Regulatory Affairs

As a member of the regulatory team, the Sr. Manager, Regulatory Affairs has responsibility to work with project team members to identify and execute regulatory strategies to obtain commercial approval of Ocular Therapeutix products worldwide. Executes project tasks relevant to regulatory affairs from product inception to product launch with minimal guidance.

Principal Duties and Responsibilities:

• Develop, document, and implement regulatory strategies for new technologies and product modifications. Collaborate with R&D and Quality to determine and execute pre-clinical test plans in support of regulatory submissions.

• Develop, prepare and maintain US medical device and drug submissions such as IND, NDA, PMA, IDE and applicable supplements and annual reports.

• Develop, coordinate, prepare and maintain international medical device submissions such as EU technical files & design dossiers and product registrations in OUS markets.

• Respond to regulatory authorities and distributors' requests for additional information.

• Review product and process documentation for assigned projects to ensure compliance with change control requirements and determining whether regulatory submissions are required.

• Review and approve product labelling and advertising.

• Assist in the development and maintenance of regulatory procedures to assure consistent, efficient and compliant regulatory processes.

• Assist with compliance activities related to GMP and ISO regulations and ISO quality system standards.

• May assist in the performance of internal quality and regulatory compliance audits and the evaluation and monitoring of corrective actions.

• Perform other regulatory affairs duties when requested.

Requirements:

• Bachelor's degree in engineering, science, and/or health profession field; advanced degree preferred.

• A minimum of six years experience in regulatory affairs with preference for at least three years experience in the pharmaceutical industry

• Demonstrated experience in preparing IND submissions for FDA; IDE, PMA or NDA submission experience desired. Understanding of US FDA regulatory affairs.

• Strong team member with ability to identify and drive process improvements.

• Excellent written and oral communication skills.

• Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.

• Excellent organizational skills and attention to detail.

• Some travel would be required for meetings and educational seminars. Ability to travel approximately 10-15%.