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Senior Manager Regulatory Operations
3 weeks ago
Senior Manager, Regulatory Operations
Location : Summit, NJ
5 days on site
Position Summary
Join a dynamic pharmaceutical company as a
Senior Manager, Regulatory Operations . This pivotal role will focus on leading and managing regulatory affairs activities, ensuring compliance with global health authority requirements, and maintaining high standards of documentation and submission quality. The right candidate will bring a blend of scientific knowledge and regulatory expertise, particularly in the biologics and oncology sectors.
Why You Should Apply
Influence global healthcare: Play a key role in bringing innovative therapies to market.
Expertise valued: Leverage your experience with eCTD, FDA, and EMA regulatory frameworks.
Growth opportunities: Progress in a supportive environment that rewards initiative and dedication.
Competitive compensation: Attractive salary and benefits package.
Advanced tools: Work with industry-leading technology like Veeva Vault RIM and DocuBridge.
What You’ll Be Doing
Manage eCTD submissions and ensure compliance with FDA and EMA standards.
Maintain and archive regulatory files using Veeva Vault RIM.
Prepare IND, NDA, BLA, and MAA submissions.
Oversee the assembly and organization of documentation for health authorities.
Draft and review administrative documentation and SOPs.
About You
Proven experience in pharmaceutical regulatory affairs.
Skilled in regulatory file archival and eCTD format.
Knowledgeable in biologics and oncology regulatory requirements.
Exceptional communication skills and detail-oriented.
How To Apply : We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to tony@scientificsearch.com and tell me why you’re interested. Or, feel free to email your resume. Please include Job#18769
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