This commercial-stage biopharmaceutical company is focused on developing, manufacturing, and commercializing innovative therapies for diseases and conditions of the eye. They are seeking a Regulatory Affairs Executive Director who can develop and implement global regulatory strategies for their portfolio of clinical programs. Reporting into the Vice President of Regulatory Affairs, you will manage assets through all phases of development and work on an upcoming NDA. This company offers an innovative pipeline, a collaborative company culture, and flexible work arrangements. With their lead candidate currently in Phase 3 trials, now is an exciting time to join this organization!

Responsibilities:

• Ensure the development and execution of global regulatory strategies for a portfolio of ophthalmic drug/device combination programs across all phases of development.
• Responsible for assisting in the preparation and compilation of domestic and international product submissions. This may include, but is not limited to: INDs, IMPDs, global CTAs, NDAs, MAAs, NDS and any other regulatory application as directed.
• Work closely with cross functional teams on an upcoming NDA for their Phase 3 program.
• Work closely with Health Authorities. This includes FDA meetings, teleconferences, and responding to Health Authority inquiries.
• Oversee all lifecycle maintenance filings (e.g. CMC supplements/notifications, 2253 submissions, annual reports, efficacy supplements and safety reporting).
• Ensure that 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 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.
• Manage one or more direct reports.
• Perform other regulatory affairs duties when requested.

Qualifications:

• Advanced degree (MS, PharmD or PhD) in a scientific discipline highly preferred.
• 10+ years in Regulatory Affairs for pharmaceutical drugs.
• Regulatory experience with ophthalmic programs is required.
• Must have drug development experience in the US, EU and UK. Experience in other parts of the world is a plus.
• Experience directly interfacing with health authorities in major markets (FDA, EMA, MHRA) is a must.
• Knowledge of global regulatory guidelines as they relate to the overall global regulatory strategy.
• Must have experience filing major marketing applications (NDAs, MAAs, BLAs, etc.)
• 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.
• Strong technical writing skills for authoring regulatory submission documents.
• Some experience managing direct reports in Regulatory Affairs.
• Excellent communication skills, with the ability to articulate complex issues clearly and persuasively.
• Must be flexible and comfortable with ambiguity in a fast-paced, small company environment.

This is a hybrid position in the Boston area. Candidates in the Northeast are strongly preferred and regular travel to the Massachusetts office will be required.

The budgeted salary range for this position is US$275,000 to $300,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.