About The Position
The Senior Director of Regulatory Affairs is responsible for providing global regulatory strategy and support as a member of multi-disciplinary teams. Manage the process from development through to approval and ensure compliance with all US and international regulatory requirements.
Requirements
- Education equivalent to a BS degree in a scientific field, plus 15+ years of experience in regulatory affairs; or Education equivalent to a 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.
- Unquestionable integrity, being able to inspire trust, and exhibit the highest ethical standards
- Excellent communication, verbal and written, and interpersonal skills with a strong ability to interact with internal teams and partners across all levels of the organization
- Ability to effectively present information and respond to questions from all levels of the organization
- Sense of urgency, flawless execution with intense focus on accuracy and accountability
- Self-starter, highly motivated, assertive, driven, and hands-on leader
- Ability to multi-task in a fast-paced environment
- Operate collaboratively with colleagues across functional areas in a science-driven environment
- Ability to work well under pressure and meet time sensitive deadlines
- Ability to work across locations and time zones
- Highly proficient using Microsoft Word, Excel, PowerPoint, Adobe, and SharePoint; or similar applications and systems
Nice To Haves
- Additional experience with EU, Japan and other global HAs 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
- experience with Veeva a plus
- Strong financial business acumen and analytical skills; ability to develop and manage expenditures in accordance with budget
Responsibilities
- Represent Regulatory Affairs in assigned project meetings and provide regulatory guidance to cross-functional project teams as appropriate; leverage experience in regulatory affairs to provide guidance to colleagues for preparation of regulatory documents
- Serve as regulatory affairs contact for external parties (for example, CROs, advisors) involved in the conduct of Pulmovant’s global clinical trials
- Develop and implement a global regulatory strategy for submissions to support clinical trials and registration in accordance with applicable regulations/guidelines (for example, US FDA, EMA, PMDA, ICH, ISO)
- Plan, prepare, author, and/or review documentation and submissions (for example, IND, CTA, BLA, NDA, MAA) to health authorities to support clinical trials, registration, maintenance of registration, and labeling of pharmaceutical products
- Liaise with global health authorities as needed
- Contribute to the development of competitive regulatory strategies that expedite development, maximize the probability of success, and mitigate risks
- Communicate project updates and risks to senior regulatory affairs management and stakeholders across the organization
- Tracking regulatory commitments and deliverables while coordinating with internal and external staff to ensure timely submissions
- Coordinate and prepare responses to requests for information from health authorities
- Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities
- Provide input into the development of internal policy and procedures for regulatory affairs in alignment with GxPs, guidance documents, and corporate objectives
- Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
- Participate in due diligence evaluations of potential in-license/partnering opportunities
Benefits
- Pulmovant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
