Manager, US Product CMC Regulatory Affairs (Hybrid)

Description

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Manager, US Product CMC Regulatory Affairs under the guidance of more experienced US Products CMC Regulatory Affairs personnel (e.g., Assoc. Dir. / Sr. Assoc. Dir.), is responsible for execution of regulatory activities required of an IND/NDA/BLA Holder for compliance to FDA requirements for BI's investigational and US market product portfolio. These activities include management of CMC and product labeling changes as well as contributing to the preparation and submission of supplemental applications and post marketing reports per US regulations. The incumbent acts as primary internal contact for NDA/BLA maintenance activities and compliance related tasks. 

Duties & Responsibilities

CMC Lifecycle Management:

• Effects timely and appropriate regulatory change management of routine CMC changes, in accord with the Corporate Change Management Procedures.
• Supports Local Change Review Committees at manufacturing sites in their evaluation of the impact of a CMC change.
• Assesses the regulatory impact of CMC changes on the US NDA/BLA.
• Defines CMC documents needed to support the change.

Labeling:

• As member of Product Labeling Review Team (PLRT) and in collaboration with US RA Labeling Content, provides regulatory support during Annual, CCDS, or ad-hoc product labeling reviews.
• Collaborates with US RA Labeling Content and Labeling Operations to facilitate submission of labeling supplements and implementation of changes to labeling.
• Provides input on Country-of-Origin markings as needed.

IND/NDA/BLA Submissions:

• Reviews, and approves regulatory documents for submission and construct in eCTD format.
• With oversight from more experienced staff, files original IND (or) IND Amendments (or) supplemental sNDA/sBLAs (or) maintenance submissions, for CMC and/or labeling of routine complexity and low business impact.
• Under the guidance of line management, supports FDA approval of submitted applications.
• Ensures CPD-3 database accurately reflects the approved CMC information.

NDA/BLA Post Marketing Reports: 

• Manages the preparation and final content and submission of the NDA/BLA Annual Report, each year within 60 days of the anniversary date of U.S. approval of the application.
• Periodic Adverse Experience Reports (e.g., PADER, PBRER); Manages the preparation and submission and contribute to content.
• Biologic Distribution Reports: Manages the preparation and submission of reports providing information about the quantity of the product distributed under the BLA.

FDA Liaison:

• Liaises with FDA in written communication and participates in FDA meetings on regulatory issues.
• Provides guidance in preparation of briefing packages.

DMFs:

• Acts as US Agent for BI’s Type II DMFs incorporated into investigational and marketed products; prepares and submits Type II DMF amendments and the DMF Annual Report on behalf of the DMF Holder.

CMC Development:

• Under the guidance of more experienced US Product CMC RA personnel, provides US CMC regulatory input to international development CMC sub teams in accordance with the CMC Functional Summary Document.
• With supervisory support, delivers US regulatory strategy and guidance for routine development programs and leverage knowledge, and experience to provide risk based regulatory analysis in accordance with regulatory expectations and development objectives from SOD through NDA/BLA registration.
• Contributes to the maintenance of BI's databases for US CMC development requirements.

CMC RA Database Maintenance, US Regulatory Intelligence & GMD Support and Medical & Technical Information support activities:

• Serves as back-up to Specialist as US entry point for the Health Authority feedback database.
• Supports senior US CMC RA staff in maintenance activities related to the Global Variations Database.
• Supports the functioning of the US RIN team and GMD Coordinator.
• Supports CMC RA staff in l