Associate Director / Senior Associate Director, CMC Regulatory Affairs - Small Molecule Development (Remote Possible)
US-BI Pharma/BI USA
 Ridgefield, CT

Associate Director / Senior Associate Director, CMC Regulatory Affairs

“Candidate to be hired at level commensurate with experience“

CMC Regulatory Affairs professional who is responsible for global and/or U.S. CMC regulatory support of 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 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, 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 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: 9 years work experience in DRA, in pharmaceutical industry or FDA
  • With M.S.: 7 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: 6 years work experience in DRA, in pharmaceutical industry or FDA
    With M.S.: 4 years
    With Ph.D.: 2 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

Our Culture:

At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.

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. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

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