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Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs, Worldwide Regulatory Affairs
4 Year Degree
Angion is a clinical stage biopharmaceutical company focused on acute kidney injury, a potentially life-threatening condition without therapeutic options. Our lead clinical asset, ANG-3777, is engineered to activate the HGF/c-MET pathway, an important mechanism in organ repair. Angion is developing ANG-3777 to meet the high unmet medical need of acute kidney injury resulting from kidney transplantation and from cardiac surgery. We are currently conducting Phase 2 and Phase 3 clinical trials with improvement in kidney function as an endpoint. Angion’s robust pipeline includes ANG-3070, an oral small molecule in development as a potential treatment for fibrosis and other severe organ damage. Learn more at www.angion.com
The Director of Regulatory Strategy Global Regulatory Lead is responsible for developing and directing the global regulatory strategy, objectives, policies and programs pertaining to development of drug products for ANG-3777 and/or ANG-3070.
Responsibilities include and are not limited to the following:
Designs and implements regulatory strategies to obtain, maintain product investigative and marketing applications, and extend product registrations.
Functions as the global regulatory lead for assigned projects, working with a cross-departmental group of regulators as part of Global Regulatory Team, including CMC and Operations at a minimum.
Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. Identify and assess regulatory risks associated with product development for assigned projects.
Leads the development of strategic plans and tactical implementation leading to the creation and submission of Regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings.
May serve as corporate liaison with regulatory Health Authority (HA) agencies to develop effective professional relationships as well as our positive company image.
Provides guidance to all appropriate departments in Angion to assure compliance with applicable regulations.
Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel.
Makes recommendations for regulatory department operating procedures. May be responsible for creating and reviewing SOPs as needed.
May supervise Regulatory Affairs Associates.
Actively trains/mentors junior staff; provides broader guidance on regulatory interpretation to Angion staff
BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.
Has a minimum of 10 years of Regulatory Affairs experience as well as additional experience in the biopharmaceutical industry in other areas. 3-5 plus years of management experience preferred.
Experience in IND phase Regulatory strategy development and implementation
Skills and Competencies:
Experience developing global regulatory strategies for products in development across therapeutic areas and in various phases of development, especially IND phase.
Strong competency in understanding regulatory requirements and emerging regulatory landscape associated with the HA(s).
Ability to read, analyze and interpret scientific and technical information, as well as regulatory documents.
Experienced in responding to inquiries from HAs.
Represents the organizational unit as key internal and external contact for GRA
Strong interaction with leadership in global regulatory affairs and development functions and senior business unit leadership.
Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands.
Excellent interpersonal, communication, analytical, managerial, and organizational skills.
Travel may be required for Regulatory Authority interactions and team meetings (post-COVID-19)
Telecommuting is allowed.
Internal Number: 001
About Angion Biomedica
Angion is a late-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel small molecule therapeutics to address acute organ injuries and fibrotic diseases.
The Angion team is dedicated to bring new therapeutic options to patients. Our initial focus is acute kidney injury and acute lung injury, where there are currently no pharmacologic therapies available, and chronic fibrotic conditions in the lung and kidney where effective treatments with more limited off-target toxicities are needed.