Regulatory Affairs Specialist IV
6 month renewable contract
RA position dedicated to the On-Body Injector Platform and strategic pharmaceutical Customers engaged in US development and launch activities. The On-Body is a new software-enabled, electromechanical wearable drug delivery device.
This is an excellent opportunity to gain hands-on experience in Regulatory Affairs with combination products, new product development, pharmaceutical company exposure, regulatory intelligence reviews, health authority interactions/audits, and project management. Contract to hire possible.
General Function: Drive completion of regulatory deliverables to enable the US launch for the On-Body Injector platform per PS RA team Strategy
Key responsibilities will include:
• Reports to RA Manager to ensure timely execution of regulatory strategies with business objectives and customer results
• Serves as RA representative on cross-functional core development team
• Authors/drafts RA deliverables (Compliance Plan, Master File submission to FDA) to enable launch of On-Body Injector
• Identifies and communicates potential risks and mitigations associated with regulatory strategies to cross-functional partners
• Maintains knowledge & awareness on assigned fields of expertise: identify applicable regulations and standards, perform regulatory intelligence/watch, educate appropriate contact partners
• As needed, reviews and/or approves product marketing claims and communication, Advertising/promotional materials, and labeling
• Manages multiple items with minimal supervision
Education and experience required:
• B.S. or B.A. degree in a technical field (e.g., engineering, biology, chemistry). Advanced degree preferred.
• Minimum five years of directly related professional experience (Regulatory) in increasingly responsible positions in the medical device, biologic, or pharmaceutical fields
• Demonstrated project management, negotiation, influencing and communication skills.
Interpersonal and Social Skills:
• Strong project management and technical communication (verbal, written) and skills
• Able to independently handle multiple tasks/projects with minimum supervision
• Self-starter with the ability to take over responsibilities
• Team player, Attention to details, Highly result-oriented
• Flexible and reliable personality; ability to manage stressful situations
• High personal integrity and ethical standards
Location: Franklin Lakes, New Jersey
• Hybrid (2-3 days/wk on site) with flexibility
Why join us?
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture and life balance components — is designed to support the varying needs of our diverse associates.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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