Boehringer Ingelheim AD/SR AD, CMC Regulatory Affairs in CONNECTICUT, United States
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.
To ensure the adequacy of required CMC documentation for global regulatory submissions (IND/CTAA, NDA/MAA) for human pharmaceutical products in the U.S. and in international (“first wave”) countries.
To manage the creation of CMC submissions to FDA (including INDs and NDAs and post-approval Supplements) and to support their approval by FDA.
To provide regulatory support and guidance on CMC post-approval changes to US marketed products, and ensure that the CMC information in BIPI’s U.S. NDAs is in compliance with applicable laws and federal regulations.
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, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities:
Provide CMC regulatory guidance on international development projects (as member of CMC Subteams), and for post-approval CMC changes; define CMC regulatory submission strategies during development and post-approval .
Define, review, approve CMC regulatory documents from technical departments in R&D/Operations for submission to FDA and (where applicable) international regulatory authorities; such submissions include CTAA/IND and amendments thereto; Information Packages for FDA meetings; MAA/NDA submissions; and post-approval CMC supplemental NDA applications (CMC supplements)
Plan, construct, and file U.S. CMC submissions for U.S. IND, NDA and post-approval CMC supplements, and support their approval by regulatory authorities
Liaise with FDA in written communication and participate in meetings on CMC regulatory issues. Will be accompanied to FDA meetings by senior DRA/CMC RA staff member.
Contribute to maintaining BI’s CMC regulatory document standards [Global Master Dossier [GMD] current for “first wave” country regulatory requirements and standards for electronic submissions. Promote use of GMD by project teams/product teams.
Maintain awareness of and expand expertise in ICH, FDA and EU guidelines related to CMC regulatory topics.
Effect timely and appropriate regulatory management of CMC changes to registered products, in accord with the Corporate Change Management Procedure. Support Local Change Review Committees at production units in their evaluation of the regulatory impact of a CMC change. Evaluate regulatory impact on US NDA (e.g., Annual Report, Supplement, etc.).
Evaluate potential licensing compounds and provide Company with CMC regulatory assessment.
Contribute to development and implementation of new and improved processes and standards within DRA.
Minimum BS/BA Chemistry or Biology or Pharmaceutical Science, advanced degree preferred
With BS/BA: 7 years work experience in DRA in pharmaceutical industry or FDAWith M.S.: 5 yearsWith Ph.D.: 3 years
Solid working knowledge of US and international CMC regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues
Excellent communication (verbal, writing and presentation) skills
Good skills in planning, organizing, and problem-solving
Excellent interpersonal skills
Willing to travel, both domestic and internationally up to ten percent of the time
Must be legally authorized to work in the United States without restriction.
Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc., Roxane Laboratories Inc., Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. and Ben Venue Laboratories Inc., is an equal opportunity employer. M/F/D/V
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings.
Organization: US-BI Pharma/BI USA
Title: AD/SR AD, CMC Regulatory Affairs
Location: Americas-United States-Connecticut
Requisition ID: 184916