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About the role
Key responsibilities & impact- Provide global regulatory strategy and support as a member of multidisciplinary teams
- Manage regulatory processes from development through approval and ensure compliance with US and international regulatory requirements
- Represent Regulatory Affairs in project meetings and provide regulatory guidance to cross-functional teams
- Serve as regulatory affairs contact for external parties, including CROs and advisors, involved in global clinical trials
- Develop and implement global regulatory strategies for clinical-trial submissions and registration under 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 and related documentation
- Liaise with global health authorities
- Contribute to regulatory strategies that expedite development, maximize success probability, and mitigate risks
- Communicate project updates and risks to senior regulatory affairs management and organizational stakeholders
- Track regulatory commitments and deliverables and coordinate internal and external staff for timely submissions
- Coordinate and prepare responses to health-authority information requests
- Prepare meeting requests and briefing documents and coordinate teams for health-authority meetings
- Provide input into regulatory policies and procedures aligned with GxPs, guidance documents, and corporate objectives
- Monitor, analyze, and disseminate regulatory intelligence affecting development programs
- Participate in due diligence evaluations of potential in-license and partnering opportunities
Requirements
What you’ll need- Education equivalent to a BS degree in a scientific field, plus 15+ years of experience in regulatory affairs; or education equivalent to an MS degree in a scientific field, plus 12-15 years of experience in regulatory affairs; or education equivalent to a PhD/PharmD degree in a scientific field, plus 8 years of experience in regulatory affairs
- Recent experience leading the preparation, submission and approval process for an NDA
- Experience working with the FDA is essential
- Additional experience with EU, Japan and other global health authorities is strongly preferred
- Experience interacting with the FDA Division of Cardiology and Nephrology strongly preferred
- Experience with pulmonary hypertension and other pulmonary diseases a plus
- Experience in drug/device combination products a plus
- Regulatory Affairs Certification (RAC) in drugs and/or devices a plus
- Excellent verbal, written, communication, interpersonal, presentation, and collaboration skills
- Ability to multitask in a fast-paced environment and work under pressure while meeting time-sensitive deadlines
- Ability to work across locations and time zones
- Highly proficient in Microsoft Word, Excel, PowerPoint, Adobe, and SharePoint or similar applications and systems; Veeva experience a plus
- Strong financial business acumen and analytical skills, including managing expenditures within budget
- Ability to travel up to 10%
Benefits
Comp & perks- Equal employment opportunities and protection from discrimination and harassment
- Travel up to 10% may be required to meet with vendors and regulators