Senior Manager – Regulatory Affairs
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Senior Manager overseeing global regulatory strategy for Avalyn's inhaled drug-device combination products. Collaborating with cross-functional teams for regulatory submissions and health authority interactions.
Responsibilities:
- Support development and execution of global regulatory strategy
- Oversee global regulatory submissions and health authority interactions
- Lead regulatory activities for assigned development programs
- Collaborate with cross-functional teams to integrate regulatory considerations
Requirements:
- Experience in regulatory affairs for drug-device combination products
- Experience with rare disease drug development
- Proven track record in late-phase clinical development
- Experience in global regulatory submissions
- Strong understanding of regulatory strategy and compliance
Similar Jobs
Compliance Director
Compliance Director providing enterprise-wide compliance leadership for healthcare initiatives at Bon Secours Mercy Health. Responsible for compliance monitoring, risk assessments, and regulatory readiness.
Principal Compliance Consultant – Data Integrity
Principal Compliance Consultant leveraging FDA experience to drive compliance strategies and solutions for life sciences clients. Leading inspections, advising on regulations, and mentoring teams in a collaborative environment.
Middle School Special Education Teacher
Special Education Teacher managing IEPs and supporting students online at Stride. Collaborating with families and staff to ensure adapted education and successful learning outcomes.
Telecom Regulatory Compliance Specialist
Telecom Regulatory Compliance Specialist for telecommunications providers ensuring compliance filings. Advancing broadband initiatives while working remotely in a mission-driven organization.
Government Contracts and Compliance Specialist
Government Contracts & Compliance Specialist at Management Solutions overseeing U.S. Government contracts, compliance, and security initiatives. Collaborating with teams to ensure contract administration and audit readiness.
Compliance Specialist
Compliance Specialist ensuring regulatory compliance within UAMS. Monitoring operations, developing policies, and supporting committees for accreditation and regulatory readiness.
Compliance Specialist
Compliance Specialist supporting affordable housing compliance requirements for Fairway Management, Inc. Responsible for documentation, audits, reporting, and compliance systems across properties.
Compliance Specialist
Compliance Specialist managing affordable housing compliance across a multi-property portfolio at Fairway Management Company. Review documentation, conduct audits, and maintain compliance records.
Compliance Specialist
Compliance Specialist at Fairway Management responsible for affordable housing compliance. Supporting audit, reporting, and regulatory adherence across properties.
Trade Compliance Analyst
Trade Compliance Analyst managing import compliance and identifying improvement opportunities at ASSA ABLOY. Support product classification and oversee import trade programs, ensuring regulatory adherence.
Global Licensing & Compliance Audit Lead
Global Licensing & Compliance Audit Lead to support regulatory audits and licensing compliance for Safeguard Global. Collaborate with stakeholders for operational validation and remediation efforts.
Trade Compliance Manager
Trade Compliance Manager overseeing export and import compliance activities across Marvell’s global locations. Partnering with multiple teams to ensure compliance with various trade regulations.
Senior Regulatory Affairs Associate
Senior Regulatory Affairs Associate in NMDP advancing regulatory compliance for clinical and regulatory submissions across cell and gene therapies. Collaborating with internal and external partners to ensure adherence to regulatory requirements.
Principal Clinical Trial Regulatory Affairs
Regulatory Subject Matter Expert focusing on regulatory submissions for clinical trials in LATAM region. Collaborating with teams to ensure compliance and efficient processes.
Senior Government Regulatory Compliance Manager
Compliance Manager providing guidance on government contract accounting regulations for Cherokee Nation Businesses. Leading audits and ensuring company practices align with legal standards.
Maritime Development – Regulatory Consultant
Maritime Consultant supporting safety and regulatory compliance for LNG facilities and maritime operations. Collaborating with USCG, FERC, and other stakeholders on safety and compliance projects.
Director, Regulatory Strategy – Contract
Director of Regulatory Strategy at Vertex responsible for global/regional regulatory strategy development. Leading regulatory submission documents and Health Authority communications oversight.
Regulatory and Start Up Specialist
Regulatory and Start Up Specialist managing Site Activation activities in France for clinical research compliance. Ensuring adherence to regulations and facilitating project timelines in a home-based role.
Compliance Advisor – Lending
Compliance Advisor providing guidance on consumer lending regulations for Aqua Finance. Assisting with compliance management tasks and maintaining regulatory expertise.
Director of GRC Operational Risk Management
Director of GRC Operational Risk Management at Live Nation ensuring effective third-party risk management. Leading a team to evaluate vendor risks and support enterprise risk initiatives.