Ventus Therapeutics · 5 hours ago

Senior Director, Head of Regulatory Affairs & Quality

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

10+ years exp

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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 global clinical trials

Develop and implement 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

Liaison with 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 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

Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs

Maintain and develop standard operating procedures (SOPs) to ensure compliance with global GxP expectations.

Oversee vendor qualification and oversight program

Assess and manage internal regulatory and quality resources, including external consultants to ensure corporate objectives are met and risks are appropriately considered.

Qualification

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Regulatory AffairsQuality Management (GxP)Regulatory SubmissionsMarketing AuthorizationRegulatory StrategySOP DevelopmentFDA AuditsPharmD//Clinical Trials

Required

10+ years of relevant regulatory/industry experience in biotech or pharmaceuticals with at least 8 years as the global Regulatory Affairs lead representative on project development teams that have led to marketing authorization

Experience in development of SOPs and managing quality issues

Leadership and management experience in building high-performing teams through coaching and development

Experience from IND through to marketing application, across all disciplines (nonclinical, clinical, CMC), as well as attending/running regulatory interactions