Senior Associate Director / Associate Director, CMC Regulatory Affairs – Biologics

09 Jun, 2020

Jobs

Senior Associate Director / Associate Director, CMC Regulatory Affairs – Biologics

Boehringer Ingelheim
Ridgefield, CT

Description:

CMC Regulatory Affairs professional who is responsible for global and U.S. CMC regulatory support of New Biologic Entities (NBEs) and combination products.  Define global CMC regulatory submission strategies; plan, construct and direct the filing of CMC submissions for clinical trial applications and market authorization 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 including combination product aspects 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 including support of IND/CTAA amendments, and postapproval changes.
  • Liaise with health authorities in and participate in meetings on CMC regulatory issues
  • Maintain awareness of and expertise in ICH, FDA and EU guidelines related to CMC regulatory topics with a focus on NBEs and Combination Products.
  • Contribute to maintaining BI’s CMC regulatory document templates to meet regulatory requirements, including standards for electronic submissions.
  • Evaluate potential licensing compounds and provide Company with CMC regulatory assessment.
  • Contribute to development and continuous improvement of processes and standards within Regulatory Affairs.

Candidate will be hired at level commensurate with experience.

 

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 Health Authorities
  • 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: 6 years work experience in DRA in pharmaceutical industry or Health Authorities
    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:

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, 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.

Learn more here

Job posted: 2020-06-09