Associate Director, Regulatory Affairs
New
P
PulmovantBiotechnology
Remote, US, Ability to work across locations and time zonesFull-TimeManager
Salary not disclosed
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Job Details
- Experience
- BS + 7 years; MS + 5 years; PhD/PharmD + 3 years
- Required Skills
- SharePointMicrosoft Office
Requirements
- BS degree in a scientific field plus 7 years of regulatory affairs experience (or MS/5 years, or PhD/PharmD/3 years).
- Essential experience working with the FDA.
- Experience with global clinical trials using a CRO.
- Strong preference for experience interacting with the FDA Division of Cardiology and Nephrology.
- Proficiency in Microsoft Word, Excel, PowerPoint, Adobe, and SharePoint (or similar systems).
- Ability to travel up to 10% to meet with vendors and regulators.
- Understanding of pulmonary hypertension and drug/device combination products is a plus.
- Regulatory Affairs Certification (RAC) is a plus.
- Experience with EU or Japan regulatory authorities is a plus.
- Strong financial business acumen and analytical skills.
Responsibilities
- Represent Regulatory Affairs in project meetings and provide strategic guidance to cross-functional teams.
- Serve as the primary regulatory affairs contact for CROs and external advisors for global clinical trials.
- Contribute to global regulatory strategy, submissions, and registration activities in accordance with FDA, EMA, PMDA, and ICH guidelines.
- Plan, author, and review documentation including IND, CTA, BLA, NDA, and MAA filings.
- Liaise with global health authorities and prepare briefing documents for agency meetings.
- Track regulatory deliverables and coordinate responses to health authority requests for information.
- Develop internal regulatory policy and procedures in alignment with GxP and corporate objectives.
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