Staff Regulatory Specialist

4 weeks ago

Vernon Hills, Illinois, United States BD (Becton, Dickinson and Company) Full time

Job Description Summary

This position is responsible for managing the various regulatory activities for new and existing combination devices and/or pharmaceuticals including but not limited to healthcare antiseptic products.

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of healthTM is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.

Purpose of Position :

This position is responsible for managing the various regulatory activities for new and existing combination devices and/or pharmaceuticals including but not limited to healthcare antiseptic products.

General Functions, Specific Responsibilities, and Authority :

  • Review CMC changes and determine regulatory reporting category in accordance with FDA guidance for changes to an approved (A)NDA
  • Write domestic device and drug regulatory submissions including NDA, ANDA, Prior Approval Supplements (PAS), Changes Being Effected (CBE), Annual Reports, IND, IND Amendments and Regulatory authority responses.
  • Determine deliverables for regulatory submissions and communicate to appropriate functional representatives to ensure timely and accurate submissions per business objectives.
  • Work with functional representatives from other areas such as R&D, Manufacturing, Medical Affairs, and Quality to review and provide input on regulatory strategy for new products and regulatory impact assessment for product changes.
  • Support OUS RA team members in order to maintain effective collaboration and to synchronize domestic and international submissions.
  • Review and Approve Labeling and Advertising and Promotional materials for compliance to internal procedures.
  • Manage and maintain the drug registrations and listings (CDER Direct/eDURLS) system and complete CARES Act reporting.
  • Support the submission of SPL via ESG/CDER Direct for all drug labeling in the US.
  • Evaluate and prepare procedures pertaining to corporate and departmental regulatory activities.
  • Monitor applicable regulatory requirements; assure compliance with corporate and external standards and guidance documents.
  • Support the quality system and internal/external audits.

Knowledge, Education, and Skills Required :

  • Excellent organizational and communications skills.
  • Candidate should be able to work independently, support project teams, to address and communicate problems and complex issues in a concise and effective manner, to manage multiple projects/tasks simultaneously, and effectively manage and prioritize regulatory submission projects.
  • Experience with MS Word, Excel, PowerPoint, and Adobe Acrobat PRO required.
  • Experience navigating FDA databases required.
  • Experience with EU MDR preferred.
  • Experience with electronic submissions and ERP systems is preferred.

Education:

  • Minimum BS required in science, such as Chemistry, Biology, Microbiology, or engineering. Masters Preferred.

Skills:

  • Strong attention to detail and Excellent organizational skills
  • History of successful regulatory submissions
  • Project management of regulatory submissions with minimal guidance
  • Effective verbal and written presentation and communication skills Comprehensive coordination and compilation of documentation

Experience:

  • Minimum of 5 years' experience in Regulatory Affairs in Combination Products and/or Pharmaceuticals
  • Minimum of 5 years' experience working with the FDA CDER
  • Strong working knowledge of US and International regulations and guidance, such as 21 CFR 820, ISO 13485, ICH guidelines and 21 CFR 210/211
  • Internal auditing experience a plus

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

#earlycareer

Primary Work Location

USA IL - Vernon Hills

Additional Locations

USA TX - El Paso - Northwestern Dr.

Work Shift

NA (United States of America)

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.


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