United Pharma Technologies Inc · 1 day ago
CMC Specialist
Warren, NJ
Contract
Onsite
Mid Level
3+ years expUnited Pharma Technologies Inc is seeking an experienced CMC Submission Specialist to support the preparation, management, and execution of Chemistry, Manufacturing, and Controls (CMC) components for an upcoming Biologics License Application (BLA). This role focuses on regulatory operations and ensures compliance with FDA and ICH requirements while managing submission activities.
BiotechnologyData ManagementHealth CareMedicalPharmaceutical
Hiring Manager
Hemasundar Annam
Responsibilities
Prepare, compile, and manage CMC sections of a Biologics License Application (BLA)
Execute regulatory submission activities using Veeva Vault RIM/Docs
Ensure compliance with FDA, ICH, and eCTD standards (structure, formatting, publishing)
Coordinate with CMC, Quality, Manufacturing, and Regulatory Affairs teams to finalize submission content
Track document readiness, manage timelines, and resolve submission issues
Support FDA information requests, amendments, and post-submission activities
Maintain accurate, compliant, and inspection-ready submission documentation
Qualification
Required
Bachelor's degree (BS) in Life Sciences or related field
3–5 years of experience in regulatory submissions with strong CMC focus
Hands-on experience supporting BLA submissions
Proficiency with Veeva Vault RIM and/or Veeva Vault Docs
Strong knowledge of eCTD formatting and publishing requirements
Working knowledge of FDA and ICH guidelines
Excellent attention to detail and ability to work in fast-paced, deadline-driven environments
Preferred
Experience supporting biologics or biotech products
Prior experience responding to FDA queries and post-submission requests
Strong cross-functional communication skills
Company
United Pharma Technologies Inc
United Pharma Technologies (UPT) is a global life-science services company delivering CQV, validation, quality, automation, and regulatory compliance solutions to the pharmaceutical, biotechnology, medical device, and diagnostics sectors.
201-500 employees
H1B Sponsorship
United Pharma Technologies Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (50)
2024 (81)
2023 (77)
2022 (69)
2021 (46)
2020 (57)
Funding
Current Stage
Growth StageTotal Funding
unknown2022-07-18Acquired
Leadership Team
Babjee M
Founder/ Srategic Partner
Company data provided by crunchbase