Senior Director, Regulatory Affairs

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Deliver global regulatory strategy and offer support as part of multidisciplinary teams.

• Oversee regulatory processes from development to approval, ensuring compliance with both US and international regulatory standards.

• Act as the Regulatory Affairs representative in project meetings, providing regulatory guidance to cross-functional teams.

• Serve as the regulatory affairs liaison for external stakeholders, including CROs and advisors, involved in global clinical trials.

• Formulate and execute global regulatory strategies for clinical trial submissions and registrations in accordance with applicable regulations and guidelines, including US FDA, EMA, PMDA, ICH, and ISO.

• Plan, prepare, author, and/or review IND, CTA, BLA, NDA, and MAA submissions along with related documentation.

• Engage with global health authorities.

• Contribute to regulatory strategies that accelerate development, enhance success probabilities, and minimize risks.

• Relay project updates and potential risks to senior regulatory affairs management and organizational stakeholders.

• Monitor regulatory commitments and deliverables, coordinating with internal and external teams for timely submissions.

• Organize and prepare responses to inquiries from health authorities.

• Create meeting requests and briefing documents and coordinate teams for health authority meetings.

• Provide input into regulatory policies and procedures consistent with GxPs, guidance documents, and corporate objectives.

• Monitor, assess, and share regulatory intelligence impacting development programs.

• Engage in due diligence evaluations for potential in-license and partnership opportunities.

⛳️ Requirements

• Education equivalent to a BS degree in a scientific discipline, plus 15+ years of regulatory affairs experience; or education equivalent to an MS degree in a scientific discipline, plus 12-15 years of regulatory affairs experience; or education equivalent to a PhD/PharmD degree in a scientific discipline, plus 8 years of regulatory affairs experience.

• Recent experience leading the preparation, submission, and approval process for an NDA.

• Essential experience working with the FDA.

• Strongly preferred additional experience with EU, Japan, and other global health authorities.

• Preferred experience interacting with the FDA Division of Cardiology and Nephrology.

• Experience with pulmonary hypertension and other pulmonary diseases is a plus.

• Experience with drug/device combination products is advantageous.

• Regulatory Affairs Certification (RAC) in drugs and/or devices is a plus.

• Exceptional verbal, written, communication, interpersonal, presentation, and collaboration skills.

• Ability to multitask in a fast-paced environment and work under pressure while meeting tight deadlines.

• Capability to work across various locations and time zones.

• Highly skilled in Microsoft Word, Excel, PowerPoint, Adobe, and SharePoint or comparable applications and systems; Veeva experience is a plus.

• Strong financial business acumen and analytical skills, including the ability to manage expenditures within budget.

• Willingness to travel up to 10%.

🏝️ Benefits

• Equal employment opportunities and protection from discrimination and harassment.

• Travel up to 10% may be required to engage with vendors and regulators.