AD / Sr AD, US Product CMC Regulatory Affairs (Remote)

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 Associate Director, US Product CMC Regulatory Affairs is responsible for the coordination and 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 responsibilities include management of CMC and product labeling changes as well as the preparation and submission of original and/or supplemental applications and post marketing reports per US FDA regulations.

The Associate Director, US Product CMC Regulatory Affairs acts as primary internal contact for all US regulatory relevant topics. Additionally, with support and guidance from the Sr. Associate Director / Director, acts as liaison to FDA for routine marketed product interactions. It is expected that the Associate Director position can support projects of increasing regulatory complexity and/or business impact.

 

The Senior Associate Director, US Product CMC Regulatory Affairs is responsible for the direction, coordination and execution of all regulatory activities required of an IND/NDA/BLA Holder for compliance to FDA requirements for BI's investigational and US market product portfolio. These responsibilities include management of CMC and product labeling changes as well as the preparation and submission of original and/or supplemental applications and post marketing reports per US FDA regulations. Responsible contact for US regulatory relevant topics, and primary liaison to FDA concerning assigned U.S. investigational and marketed product interactions.

The Senior Associate Director position is expected to support projects of high regulatory complexity with moderate business impact. In addition, this role assumes a leadership position for regulatory topics within BI, monitoring developments in the regulatory landscape, assessing impacts on the organization and informing colleagues and affected functions as appropriate.

Duties & Responsibilities

• Supervises, coaches, and develops the skills of CMC RA Specialists.

CMC Lifecycle Management:

• Effects timely and appropriate regulatory change management of CMC changes, including those of increasing complexity and/or business impact, 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 the proposed CMC changes on the US NDA/BLA. Define CMC documents needed to support the change.
• With supervisory support, evaluates submission documentation for gaps in data/information and identifies risks/mitigation strategies as appropriate.
• Contributes to maintenance of BI’s databases on post approval requirements (e.g., Variations database) for US requirements.

Labeling:

• As member of Product Labeling Review Team (PLRT) and in collaboration with US RA Labeling Content, provide 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, constructs in eCTD format, and file, original IND/NDA/BLA (or) IND Amendments (or) supplemental sNDA/sBLA submissions for CMC and/or labeling and supports their approval by FDA, including those of increased complexity and/or business impact.
• Freedom to act in addressing standard FDA comments with minimal potential impact on submission timelines or approvals and leverages line management support to address more complex or unusual questions.
• With modest oversight, manages the negotiation of labeling changes with FDA as needed.

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 Exp