Senior Manager, Regulatory Affairs

Liquidia•,

About The Position

The Senior Manager, Regulatory Affairs supports the development and execution of regulatory strategy throughout clinical development and commercialization for assigned rare disease and cardio-pulmonary drug-device combination product programs. Working under the direction of the Director/Senior Director, Regulatory Affairs, this role contributes regulatory expertise across drug and combination product requirements, supports compliance with global regulations, and helps prepare and coordinate worldwide submissions. The position collaborates with Clinical Development/Operations, Safety, CMC, Project Management, and other clinical support functions on submission planning, labeling, and lifecycle management. It executes regulatory deliverables with sound judgment and helps ensure regulatory readiness for assigned assets and business objectives. The role also supports global regulatory strategy and program planning; prepares and coordinates filings and health authority responses; supports clinical trial regulatory requirements and routine submissions; and partners across functions on program development and commercialization. Business travel of 10–20% may be required.

Requirements

Bachelor's degree in life sciences, engineering, biology, or a related field.
At least 5 years of industry experience with increasing responsibility in regulatory affairs.
Experience managing regulatory filings and clinical trial execution in the biopharmaceutical landscape.
Working knowledge of global regulatory requirements for clinical development and commercialization.
Ability to interpret and apply evolving guidance to program execution under the direction of regulatory leadership.
Experience with global regulatory filings, including US FDA and EMA, in support of pre- and post-approval programs.
Exposure to global clinical trials and GxP and ISO/EU MDR requirements for combination products.
Experience supporting interactions with global regulatory agencies.
Ability to build effective working relationships with internal and external stakeholders.
Strong cross-functional collaboration skills and experience supporting alignment in a matrixed environment.
Strong interpersonal, verbal, written, and presentation skills for communication with internal and external stakeholders.
Strong organizational skills and ability to manage multiple deliverables and competing priorities.
Analytical ability to evaluate regulatory risks and support mitigation strategies to achieve business goals.
High degree of integrity, sound judgment, and commitment to compliance.

Nice To Haves

Experience at a small-to-midsize biotechnology company and/or with drug-device combination products.
Working understanding of drug development and combination product development.
Regulatory filing experience in LATAM and Asia, such as China.
Experience with document management systems such as Veeva RIM.

Responsibilities

Support development and implementation of global regulatory strategies and contribute to development program planning, including anticipating changes in the regulatory environment and approval requirements.
Assist in identifying regulatory pathways and approval requirements for assigned programs, including regional differences, under regulatory leadership.
Prepare, review, coordinate, and supervise global regulatory filings executed by CROs for clinical development and commercialization of drug and delivery-device combination products.
Draft and coordinate responses to health authority requests.
Support alignment of submissions with global eCTD and combination product requirements.
Support clinical trial execution requirements, including registry posting development, essential document packages, informed consent reviews, document redactions, translation oversight, and day-to-day regulatory inputs.
Oversee routine regulatory submissions, including DSURs/IND Annual Report appendices, NDA Annual Reports, PADERs, and investigator information.
Support and help maintain relationships with regulatory agencies, including preparing for and participating in health authority meetings and interactions.
Maintain working knowledge of regulatory policies, guidance, and environments, and build relationships with relevant stakeholders in the assigned disease area.
Accurately and promptly summarize and communicate health authority correspondence to regulatory leadership and project teams.
Partner with Clinical Development/Operations, Safety, Project Management, CMC, Commercial, and Medical Affairs to support program development and commercialization.
Support regulatory activities for assigned assets, such as RA-CMC, Device RA, Reg Ops, and AdPromo, as needed.
Represent Regulatory in study team meetings and escalate issues to regulatory leadership as appropriate.
Support development and implementation of SOPs for regulatory affairs, clinical research/trials, and related activities.