Regulatory Affairs Specialist - Pharma

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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

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. The ideal candidate is a Regulatory Affairs professional with 5+ years of pharmaceutical and/or combination product experience, strong direct interaction with FDA CDER, demonstrated success leading NDA/ANDA/PAS/CBE submissions, deep knowledge of FDA and global regulatory requirements, and the ability to independently manage complex regulatory projects while partnering effectively across R&D, Quality, Manufacturing, Medical Affairs, and Commercial teams.

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 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 Marketing, 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
• Provide periodic written or verbal updates and strategy to Leadership
• Review and Approve Labeling and Advertising and Promotional materials for compliance to internal procedures.
• Manage and maintain the drug registrations and listings (CDER Direct/eDRLS) 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.
• Maintain and build upon CDER relationship
• Guide team on Pharma/Combination product regulations, processes & best practices

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 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 and meetings with FDA CDER
• Project management of regulatory submissions with minimal guidance
• Effective verbal and written presentation and communication skills Comprehensive coordination and compilation of documentation
• Influence without authority;
  Cross…