Director of Regulatory Affairs

As a part of the Regulatory Affairs team, the Director will work with Department management and project team members to identify and execute regulatory strategies to support clinical development and commercialization of Ocular Therapeutix products globally. Execute project tasks relevant to regulatory affairs throughout product lifecyle(s). A unique position with exposure to medical device, pharmaceutical product development, drug / device combination products, advertising and promotion influence, non-clinical, clinical and CMC strategy support.

Principal Duties and Responsibilities include the following:

• Responsible for assisting in the preparation and compilation of domestic and international product submissions, with guidance. This may include, but is not limited to: INDs, IMPDs, global CTAs, NDAs, MAAs, NDS and any other regulatory application as directed. This also includes all lifecycle maintenance filings necessary to support these applications (e.g. CMC supplements/notifications, 2253 submissions, annual reports, efficacy supplements and safety reporting).
• Ensure agency establishment registrations and device/drug listings are completed on time.
• 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.
• Provide regulatory research information as requested.
• Perform other regulatory affairs duties when requested.

Supervisory Responsibilities:

• Ability to manage one or more direct reports

Qualification Requirements:

Education:

• Bachelor’s degree in engineering, science, and/or health profession field.

Experience:

• 10 years experience in regulatory affairs in the pharmaceutical industry; 3-5 years of experience in managerial role.
• Demonstrated experience in preparing and gaining acceptance for all types of US based submissions, global investigational and commercial submission experience preferred.
• Proven track record of increasing responsibilities with skills in leadership and management.

Knowledge/Skill:

• Proven track record of increasing responsibilities with skills in leadership and management.
• Be a self-starter and have the ability to work independently to drive projects in accordance with established company objectives.
• Strong technical writing skills for authoring regulatory submission documents.
• Strong understanding of global regulatory affairs regulations and expectations.
• Strong team member with ability to identify and drive process improvements.
• Excellent verbal and written communications skills.
• Excellent organizational skills and attention to detail.

Working Conditions

• Mostly office-based in Bedford, MA
• Ability to travel approximately 5 - 10% (domestic and some international) for applicable meetings and/or educational seminars

Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/.