Staff Regulatory Affairs Specialist - Pharma

Becton Dickinson Medical Devices•Vernon Hills, IL

3d•Onsite

About The 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. 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.

Requirements

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.
Minimum BS required in science - such as Chemistry, Biology, Microbiology, or engineering.
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 functional collaboration
Relationship building
Minimum of 5 years’ experience in Regulatory Affairs in Combination Products and/or Pharmaceuticals with experience working directly 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

Nice To Haves

Masters Preferred.
Experience with electronic submissions and ERP systems is preferred.
Internal auditing experience a plus

Responsibilities

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