Job Description Summary

The Senior Regulatory Affairs (RA) Specialist within the BD Interventional Surgical Devices Business unit will work on regulatory strategy and various regulatory activities for new and existing combination devices and/or pharmaceuticals including but not limited to healthcare antiseptic products. Under the mentorship of the Sr. RA Manager of Regulatory Affairs, they are responsible for the development of complex global regulatory strategies and preparation of regulatory submissions required to market medical devices in the U.S. The Senior RA Specialist will also support related regulatory affairs activities, such as development, execution and management of procedures and systems to ensure that the product development process - including clinical studies and strategy - addresses all regulatory requirements and objectives of the business. The incumbent should have demonstrated leadership and success working in cross-functional teams and will perform essential duties and responsibilities with minimal direction while providing mentorship to more junior regulatory associates.

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 health™ 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. 

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

• Understands and has expertise in US Pharmaceutical and OTC Monograph regulations and develops different regulatory pathways and communicates options to cross functional teams.

• Provides regulatory guidance for one or more program(s), including participation in external Food and Drug Administration (FDA) meetings, internal core team meetings and providing technical guidance on complex regulatory issues.

• Creates and manages programs with multiple workstreams and identifies key dependencies and critical path items.

• Develops and leverages working relationships with key personnel/representatives from FDA and oversees communications with regulators.

• 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. 

• Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.

• 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.

• Assess necessity for reporting changes to FDA for device modifications. Prepare robust justifications for changes that do not require notices. Address and resolve requests for additional information.

• Determine deliverables for regulatory submissions and communicate to appropriate functional representatives to ensure timely and accurate submissions per business objectives. 

• 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. 

Education and Experience:

• Bachelor’s degree or advanced degree in technical area such as biology, chemistry, engineering or med