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AD/Senior AD, CMC Regulatory Affairs

CMC Regulatory Affairs professional who is responsible for global and/or U.S. CMC regulatory support of New Biologic Entities (NBEs) and/or New Chemical Entities.  Define CMC regulatory submission strategies; plan, construct and direct the filing of CMC submissions for clinical trial applications and market authorization applications (including U.S. post approval supplemental applications), and support review and approval by regulatory agencies.  Liaise with regulatory authorities via written communication and participate in meetings on CMC topics.   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 input to global development teams for NBEs and/or NCEs on CMC regulatory strategies to achieve development objectives.  Advise on opportunities for seeking scientific advice from regulatory authorities. Define and review content of information package to achieve meeting objectives. Define, plan and manage preparation of CMC submissions for U.S. and international applications e.g., IND/CTAA, BLA/NDA/MAA and support their approval by regulatory authorities. Liaise with FDA in written communication and participate in meetings on CMC regulatory issues Maintain awareness of and expertise in ICH, FDA and EU guidelines related to CMC regulatory topics. Contribute to maintaining BI's CMC regulatory document templates to meet regulatory requirements, including standards for electronic submissions. Effect timely and appropriate regulatory management of post-approval CMC changes to U.S. market products. Evaluate regulatory impact on US BLA/NDA and make appropriate submissions (e.g., Annual Report, Supplement). Evaluate potential licensing compounds and provide Company with CMC regulatory assessment. Contribute to development and continuous improvement of processes and standards within Regulatory Affairs.   Requirements SR AD: Minimum BS/BA Chemistry or Biology or Pharmaceutical Science, advanced degree preferred With BS/BA: 8 years work experience in DRA in pharmaceutical industry or FDA With M.S.:    6 years With Ph.D.:   4 years Extensive 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 Excellent skills in planning, organizing, decision-making and problem-solving Excellent interpersonal and management skills Willing to travel, both domestic and internationally up to ten percent of the time Requirements AD: 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 FDA With M.S.:         5 years With 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   Eligibility Requirements: Must be legally authorized to work in the United States 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 1811535
Salary Range: NA
Minimum Qualification
8 - 10 years

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