Regulatory Affairs Specialist IV - new job in Franklin Lakes, US

Regulatory Affairs Specialist IV
  • $80 - $100 per Hour
  • Temporary
  • Franklin Lakes NJ, US Franklin Lakes BERGEN US 07417
Job Ref: JO000132379
Sector: Clinical
Sub-sector: Reg & Compliance
Date Added: 26 July 2022

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.


21/08/2022 12:00:00
USD 80.00 100.00 Hour
Contact Consultant:
Jennifer Law

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