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Breckenridge Pharmaceutical, Inc. considers all qualified applicants for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, disability or status as a protected veteran or any other characteristic protected by law.

All positions are in the Berlin, CT office unless otherwise noted in the job description

For more information on these career opportunities, please e-mail jobs@bpirx.com

 

Back To Current Job Listings: SPECIALIST, REGULATORY AFFAIRS
SPECIALIST, REGULATORY AFFAIRS
[Mar 03, 2020]

SPECIALIST, REGULATORY AFFAIRS

 

JOB SUMMARY:

 

The Regulatory Affairs Specialist is responsible for compiling and maintaining compliant FDA drug product drug applications throughout product lifecycle from initial development to product termination and managing projects for on-time completion of milestone activities in support of project timelines and commercial business needs.    The Regulatory Affairs Specialist is a self-motivated, detail oriented, flexible team player who is able to multi-task, and work independently with minimal supervision.

 

DUTIES AND RESPONSIBILITIES: 

 

  • Manage, prepare and publish using eCTD software well-organized, scientifically sound CMC-related regulatory submissions which include ANDAs, INDs, 505(b)(2) NDAs, DMFs, Amendments, and Supplements that comply with applicable regulatory requirements in eCTD format.

 

  • Provide project management related to activities required for FDA submissions for internal and external projects; informing other departments and management of impacts to critical path deliverables, timelines, and budgets.

 

  • Review technical reports, summary documents and change controls (chemistry, manufacturing and analytical controls) for appropriate content and justifications as well as for adherence to regulatory guidelines, strategies, and commitments.

 

  • Work with partners to create product labeling compliant with BPI, FDA, and compendial requirements for drug products, dietary supplements, medical foods, and foods for special dietary use. 

 

  • Educate partners regarding U.S. regulatory requirements including, but not limited to cGMPs, CMC requirements, and GDUFA requirements. 

 

  • Resolve project related issues through application of critical thinking, research of regulations and technology, and coordination with partners/BPI Quality.

 

  • Act as a US Agent for foreign and domestic partners. Able to provide expert Regulatory guidance with respect to original ANDA applications, deficiency responses and represent the partner in all aspects of the application.

 

  • Primary point-of-contact with FDA and international governmental agencies for exchange of information regarding pending and approved projects.

 

  • Launch new drug products, which includes filing PLAIR, performing product inspections, assisting with completion of vendor files, compiling of required launch documents, and drug listing. 

 

  • Train junior department members in above areas, as required.

 

 

ESSENTIAL QUALIFICATIONS, EDUCATION AND EXPERIENCE

 

  • Bachelor’s degree required in a scientific disciple such as Chemistry, Biology, or Pharmacy. Graduate degree preferred.

 

  • Minimum 10 years’ experience in the Pharmaceutical Industry.  A minimum of 2 years’ previous experience in drug regulatory affairs required; prior managerial experience is a plus.

 

  • Experienced in collaborating with multiple inter-disciplinary project teams.

 

  • Strong written and verbal communication skills.

 

  • Familiar with cGMP requirements.

 

  • Knowledge/experience with complex dosage forms; steriles, parenterals, transdermals is a plus.

 

  • Computer skills required:  Microsoft Word, Adobe Acrobat, Microsoft Office Suite, and eCTD publishing software.

 

  • Sometimes required to attend off-hours teleconferences with overseas partners as well as on-site meetings with domestic and overseas partners.

 

 

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