Postdoctoral Fellow Regulatory Affairs - Chemistry, Manufacturing & Control

Description

The Clinical Development and Medical Affairs Fellow is a post-doctoral pharmacist position that will obtain broad exposure to BI US Medical functions including, but not limited to -- Medical Affairs and Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs. This position will require the Fellow to develop competencies necessary to contribute to their respective functional area within a pharmaceutical company.

The Fellow will be based at Boehringer Ingelheim´s U.S. headquarters in Ridgefield, CT, working on a particular or multiple therapeutic areas (TAs) in the areas of cardiology, diabetes, immunology, oncology, and respiratory. Through a series of rotations either within or outside of the assigned area, the Fellow will also gain an understanding of the broad range of opportunities available to a pharmacist in the pharmaceutical industry.

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 a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance.

Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

The Regulatory Affairs (RA) Fellowship within the Chemistry, Manufacturing and Controls (CMC) discipline is designed to provide pharmacists with a 2-year exposure to the regulatory aspects of CMC during the lifecycle of BI assets. The selected Fellow will also gain experience coordinating and executing regulatory activities required of an NDA Holder for compliance to FDA requirements for U.S. products in BIPI's commercial portfolio.

These responsibilities include management of CMC and product labeling changes as well as the preparation and submission of supplemental applications and post-marketing reports per US regulations.

The Fellow will be exposed to projects involving both US marketed products and early phase US INDs. Under supervision, the Fellow will:

Act as a company liaison with the US Food and Drug Administration.

Research information on regulatory CMC standards and departmental policies.

Provide strategic regulatory input as it pertains to US Marketed Products

Author, review and update CMC documentation US registered products.

The Fellow will develop basic regulatory expertise/knowledge in one or more therapeutic areas covering multiple dosage forms while interacting effectively within Regulatory Affairs and across CMC stakeholder functions, as a regulatory advocate to achieve common goals for assigned projects.

• CMC Lifecycle Management:
  Effect timely and appropriate regulatory change management of CMC changes, including those of increasing complexity and/or business impact, in accordance with the Corporate Change Management Procedures. Support Local Change Review Committees at manufacturing sites in their evaluation of the impact of a CMC change. Assess the regulatory impact of CMC changes on the US NDA. Define CMC documents needed to support the change.
  
  Contribute to the maintenance of BI’s databases on post approval requirements (e.g., Variations database for US requirements).

• sNDA Submissions:
  Review, and approve regulatory documents for submission, construct in eCTD format, and file supplemental NDA (sNDA) submissions for CMC changes, including those of…