Director/Senior Director, Regulatory Affairs
Job Description:
• 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
Requirements:
• Education equivalent to a BS degree in a scientific field, plus 12 years of experience in regulatory affairs; or
• Education equivalent to a MS degree in a scientific field, plus 10 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
• Experience working with the FDA is essential. 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
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.
• Travel up to 10% may be required to meet with vendors and regulators
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• 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
Requirements:
• Education equivalent to a BS degree in a scientific field, plus 12 years of experience in regulatory affairs; or
• Education equivalent to a MS degree in a scientific field, plus 10 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
• Experience working with the FDA is essential. 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
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.
• Travel up to 10% may be required to meet with vendors and regulators
Apply tot his job
Apply To this Job