Director, Regulatory Affairs

The Director, Regulatory Affairs leads global regulatory strategy, reporting, compliance, labeling, and regulatory intelligence to support product development, approval, and market expansion. This role provides regulatory leadership for ophthalmology drug and combination product programs from early development through registration and global launch, using a U.S.-led approach aligned with key ex-U.S. regions. The Director partners cross-functionally with Clinical, Nonclinical, CMC, Quality, Safety, and Regulatory Operations to develop global regulatory strategies, lead health authority interactions, ensure high-quality submissions, and manage regulatory risk across the product lifecycle. Responsibilities include preparation for and leadership of health authority meetings (e.g., pre-IND, end-of-phase, pre-NDA/BLA). The Director, Regulatory Affairs typically includes people and/or matrix leadership of regulatory teams and external vendors. Responsibilities:

• Define and execute global regulatory strategies for ophthalmology drug and combination product programs, aligned with development, CMC, and commercial objectives.
• Provide guidance and direction regarding regulatory strategy to department.
• Interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities.
• Drive innovative strategies to enable successful regulatory submissions and improve the probability of approval.
• Point of contact with Health Authorities and ability to manage the relationship with Health Authorities as assigned.
• Develop and mentor team of individual contributors/subject matter experts.
• Provide input to regulatory budget process.

Qualifications:

• Bachelors degree required; advanced degree (Masters, PhD, PharmD) preferred
• 10-15+ years in Regulatory Affairs or relevant experience in a regulated environment
• Global portfolio management and strategy experience and strong familiarity with registration requirements in ex-U.S. regions.
• RAPS certification desired

Specific Skills:

• Deep understanding of regulatory authority policies, processes, and information systems, with the ability to apply them to product development, labeling, and pre- and post-market submissions.
• Strong scientific and analytical skills to critically evaluate data, technical arguments, and risk, serving as a regulatory subject matter expert internally and externally.
• Strategic mindset with strong business acumen to anticipate regulatory changes, make risk-based recommendations, and drive successful approvals while minimizing business impact.
• Proven leadership and people management abilities, including coaching and mentoring, influencing cross-functional teams, and providing strategic direction beyond direct reporting lines.
• Excellent communication, organizational, and writing skills, with strong attention to detail and document accuracy.
• Demonstrated ability to manage multiple priorities, coordinate resources, meet tight deadlines, and work independently in a fast-changing environment.
• Strong interpersonal and influencing skills to engage internal and external stakeholders, including key opinion leaders, advisory boards, and advocacy groups.
• Commitment to teamwork, continuous learning, process improvement, operational excellence, and performance metrics.

We offer competitive salary & excellent benefits including:

• Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date
• 401K Plan with company match and ongoing company contribution
• Paid time off - vacation (3 weeks - prorated upon hire), floating holidays and sick time
• Employee Stock Purchase Plan with company match
• Employee Incentive Bonus
• Tuition Reimbursement (select degrees)
• Ongoing performance feedback and annual compensation review

For U.S. locations that require disclosure of compensation, the starting pay for this role is between $165,000.00 and $220,000.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors. U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation. Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. Apply tot his job Apply To this Job