Senior Regulatory Affairs Specialist

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, the specialist is responsible for the development of complex global regulatory strategies and preparation of regulatory submissions required to market medical devices in the U.S. The role also supports 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 business objectives.

The incumbent should have demonstrated leadership and success working in cross‑functional teams and will perform essential duties with minimal direction while providing mentorship to more junior regulatory associates.

• Understand and has expertise in US Pharmaceutical and OTC Monograph regulations and develop different regulatory pathways, communicating options to cross‑functional teams.
• Provide regulatory guidance for one or more programs, including participation in FDA meetings, internal core team meetings, and providing technical guidance on complex regulatory issues.
• Create and manage programs with multiple work streams and identify key dependencies and critical path items.
• Develop and leverage working relationships with key personnel/representatives from FDA and oversee communications with regulators.
• Work with functional representatives from 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.
• Ensure that the clinical and non‑clinical data, in conjunction with regulatory strategy, are consistent with 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, preparing robust justifications for changes that do not require notices and addressing and resolving 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 to maintain effective collaboration and synchronize domestic and international submissions.
• Review and approve labeling and advertising and promotional materials for compliance with 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 U.S.
• 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.

• Bachelor’s degree or advanced degree in a technical area such as biology, chemistry, engineering, or a medical-related field and a minimum of five years of experience, with demonstrated support of regulatory submission development and approval from the FDA and other global regulatory agencies.
• Excellent organizational and communication skills.
• 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 preferred.

• Proficient in using Microsoft Word, Excel, PowerPoint, and…