Director/Senior Director, Regulatory Affairs

Job reputed company: • Represent Regulatory Affairs in assigned project meetings and reputed company regulatory guidance to cross-functional project teams as appropriate; reputed company experience in regulatory affairs to reputed company 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 reputed company’s global reputed company • reputed company and implement a global regulatory reputed company for submissions to support reputed company 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 reputed company, 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 reputed company, 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 reputed company staff to ensure reputed company 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 • reputed company 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 reputed company that may reputed company 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: • reputed company provides equal employment opportunities to reputed company and applicants for employment and prohibits discrimination and harassment of any type without reputed company to race, reputed company, religion, age, sex, national reputed company, disability status, genetics, protected veteran status, sexual orientation, gender identity or reputed company, 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