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Ledgewood, New Jersey BD
The Senior Regulatory Affairs Specialist will work in BD Medical - Pharmaceutical Systems Business Unit taking on a lead role at the project level in carrying out regulatory strategy and compliance plans to promote and support new drug delivery solutions for pharma combination product development. The incumbent will represent the RA function on designated platform core team executing regulatory strategies to support cross-functional stand-alone device and combination product development efforts for platform growth and global expansion. The ideal candidate will have medical device and drug-device combination product experience in the US and EU. Job Description Essential Job Responsibilities: Works with RA and Platform Leaders to ensure timely execution of regulatory strategies with business objectives and customer deliverables for assigned product platform Develops regulatory pathways for new products, product modifications and product switches; executes regulatory strategies and planning for submissions or support of customers' regulatory submissions Partners with and supports pharma customers in securing timely development, submissions, addressing health authority questions and regulatory drug-device combination products approvals in US, EU and other markets Performs regulatory impact assessment of changes related to design, improvements and customer experience for timely execution and global compliance and assigned platform Develops and maintains knowledge & awareness on regulations and standards, perform intelligence/watch, educate and partners Identifies and communicates potential risks and mitigations associated with regulatory strategies to partners Support to customers for regulatory advice and registration of their products and interact as necessary with the U.S. regulatory agencies and EU Notified Bodies with a sense of urgency Reviews product marketing claims and communication, promotional materials, and labeling Conduct regulatory trainings for staff and for business partners (e.g., Platform, R&D, Marketing and Pharma Partners) Participates in internal/external trade, professional, and standards development organizations Handles multiple projects with attention to detail for health authority submission and audit readiness Experience and Education: B.S. degree in a technical discipline (e.g., pharmacy, engineering, biology, chemistry). Advanced degree preferred. Minimum five years of directly related professional experience (regulatory or quality compliance) experience in the medical device, biologic, or pharmaceutical fields Proven project management, negotiation, influencing and communication (written and oral) skills. Knowledge, Skills and Abilities: Knowledge in pharmaceutical and medical devices regulations registration requirements and pathways (variations, renewals, supplements), in the US and EU markets. Global experience is a plus. Understanding of product development cycle, clinical phases, organizational change and cGMP/quality management systems is helpful. Knowledge of preferable syringes and injector devices (pen injector, auto-injector or on-body injector) is a plus. Experience in meeting with, making presentations to, and negotiating with leadership and/or regulatory agencies Ability to use your time productively and efficiently (structured and self-organized with strong project management skills) Ability to resolve problems and to make regulatory decisions under pressure Ability to adapt, multitask and respond quickly in a constantly evolving and often ambiguous environment, Strong teammate. Ability to drive and maintain favorable customer experience and customer-centricity (internal & external) EEO Statement Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status Primary Work Location USA NJ - Franklin Lakes Additional Locations Work Shift NA (United States of America)