Associate Director, Regulatory Affairs

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

📋 Description

• Act as the representative for Regulatory Affairs in designated project meetings, offering regulatory insights to cross-functional project teams.

• Assist colleagues in the creation of regulatory documents.

• Serve as the regulatory affairs point of contact for external entities such as CROs and advisors involved in global clinical trials.

• Contribute to the global regulatory strategy concerning clinical trial and registration submissions in compliance with US FDA, EMA, PMDA, ICH, and ISO standards.

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

• Liaise with global health authorities as per agreements established with regulatory leadership.

• Formulate competitive regulatory strategies that accelerate development, enhance the likelihood of success, and reduce risks.

• Communicate project updates and potential risks to senior management within Regulatory Affairs and relevant organizational stakeholders.

• Monitor regulatory deliverables and coordinate both internal and external personnel to ensure timely submissions.

• Organize and prepare responses to information requests from health authorities.

• Draft meeting requests and briefing documents, coordinating teams for meetings with health authorities.

• Contribute to the development of internal Regulatory Affairs policies and procedures in line with GxPs, guidance documents, and corporate objectives.

• Monitor, analyze, and share regulatory intelligence.

⛳️ Requirements

• A BS degree in a scientific discipline with 7 years of experience in regulatory affairs, an MS degree with 5 years, or a PhD/PharmD degree with 3 years of relevant experience.

• Essential experience working with the FDA.

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

• Experience with global clinical trials utilizing a CRO.

• Strong preference for experience interacting with the FDA Division of Cardiology and Nephrology.

• Experience in pulmonary hypertension and other pulmonary diseases is advantageous.

• Familiarity with drug/device combination products is a plus.

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

• Exceptional verbal and written communication skills, along with strong interpersonal abilities.

• Capability to effectively present information and address inquiries from all organizational levels.

• Competence to manage multiple tasks in a dynamic environment.

• Ability to perform well under pressure and meet tight deadlines.

• Willingness to work across various locations and time zones.

• Highly skilled in Microsoft Word, Excel, PowerPoint, Adobe, SharePoint, or similar applications and systems.

• Experience with Veeva is advantageous.

• Strong financial acumen and analytical skills; ability to develop and manage expenses in alignment with budgetary constraints.

• Demonstrated integrity and adherence to the highest ethical standards.

🏝️ Benefits

• Equal employment opportunities alongside a strict prohibition of discrimination and harassment.

• Up to 10% travel may be necessary to meet with vendors and regulators.