Senior Manager, Regulatory Affairs

Liquidia•,

3d•Hybrid

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, cardio-pulmonary drug-device combination product programs. This position works under the direction of the Director/Senior Director, Regulatory Affairs, contributing regulatory expertise across drug and combination product requirements, supporting compliance with global regulations, and helping to prepare and coordinate submissions worldwide. The Senior Manager collaborates closely with Clinical Development/Operations, Safety, CMC, Project Management, and other clinical support functions on submission planning, labeling, and lifecycle management activities. This role supports assigned programs by executing regulatory deliverables with sound judgment and helping to drive regulatory readiness so the company can meet business objectives for its assigned assets.

Requirements

Bachelor's degree in life sciences, engineering, biology, or related field required.
Minimum 5 years of industry experience with increasing responsibility in regulatory affairs required.
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 with experience supporting alignment in a matrixed environment.
Compelling interpersonal, verbal, written, and presentation skills in communication with internal and external stakeholders.
Strong organizational skills with the ability to manage multiple deliverables and competing priorities.
Sound analytical capabilities in evaluating regulatory risks and supporting mitigation strategies to achieve business goals.
High degree of integrity, sound judgment, and commitment to compliance.

Nice To Haves

Experience managing regulatory filings and clinical trial execution in the bio-pharma landscape; experience with a small-to-midsize biotechnology company and/or drug-device combination products preferred.
Working understanding of drug development and combination product development is a plus.
LATAM and Asia experience (i.e., China) a plus.
Experience with document management systems (e.g., Veeva RIM) a plus

Responsibilities

Support the development and implementation of global regulatory strategies and contribute to development program planning to help anticipate changes in the regulatory environment and approval requirements.
Assist in identifying regulatory pathways and approval requirements for assigned programs, including regional differences, under the guidance of regulatory leadership.
Prepare, review, coordinate, and supervise global regulatory filings executed by CROs (including US, Europe, APAC, LATAM, and other applicable regions) supporting clinical development and commercialization of drug and delivery device combination products, under the direction of regulatory leadership. Filings include INDs/CTAs and amendments; NDAs/MAAs and supplements/variations; regulatory designation requests; and lifecycle management submissions.
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 other day to day regulatory inputs for clinical trial execution.
Responsible for overseeing routine regulatory submissions (i.e., DSURs/IND Annual Report appendices; NDA Annual Report, PADERs, investigator information).
Support and help maintain relationships with regulatory agencies, including preparation for and participation in health authority meetings and interactions.
Maintain working knowledge of regulatory policies, guidance, and environments; build relationships with relevant stakeholders within the assigned disease area.
Summarize and communicate health authority correspondence accurately and promptly 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 asset(s) (e.g., RA-CMC, Device RA, Reg Ops, AdPromo) as needed.
Represent Regulatory in study team meetings, escalating issues to regulatory leadership as appropriate.
Support the development and implementation of SOPs for regulatory affairs, clinical research/trials, and related activities.