Senior Regulatory Affairs Specialist

Becton Dickinson Medical Devices • Warwick, RI

29d

About The Position

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. 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.

Requirements

• Bachelor’s degree or advanced degree in technical area such as biology, chemistry, engineering or 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 communications skills.
• Experience with MS Word, Excel, PowerPoint, and Adobe Acrobat PRO required.
• Experience navigating FDA databases required.
• Proficient in using Microsoft Word, Excel, PowerPoint, and OneNote.
• Strong communication (written, oral) and project management skills.
• Ability to plan and schedule multiple priorities in a concurrent fashion.
• Ability to review, collate and summarize scientific and technical data.
• Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices.
• Excellent problem solving and analytical skills.
• Excellent written and oral communication skills with ability to effectively communicate at varying levels in the organization.
• Experience with authoring NDAs/ANDAs. (CTD Format)
• Experience authoring and managing regulatory submissions and/or registrations, with responsibility for communicating with regulatory authorities.
• Experience facilitating and designing communication strategies to FDA.

Nice To Haves

• Experience with EU MDR preferred.
• Experience with electronic submissions and ERP systems is preferred.
• Advanced degree
• Experience with regulatory tools and systems. (CDER Direct/eDURLS)
• Knowledge/Expertise of Quality Systems.
• Proven background managing complex and strategic regulatory projects from initiation to conclusion.
• Detail-oriented, methodical and able to handle regulatory information and submissions with a high degree of accuracy.
• Previous experience facilitating meetings with FDA, reviewing submissions, registrations and/or notifications from varying product lines or programs.

Responsibilities

• 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.

Benefits

• At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You .

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees