Sr. Regulatory Affairs Associate - CMC Specialist - Job ID: 247789
Medix™, Trenton, New Jersey, United States
Senior Regulatory Affairs Associate (CMC Specialist)
Location:
Hybrid – Union County, NJ (Northern-Central Jersey) – 2 days onsite
Compensation:
Up to $120,000 + Benefits
Sponsorship:
H1B Transfers welcome (No New H1B or STEM OPT)
The Opportunity Are you a Regulatory Affairs professional who excels at the "writing" rather than just the "submitting"? We are seeking a
Senior Regulatory Affairs Associate
to join a growing, high-impact team in Union County. This is a critical role where you will serve as the
primary author
for CMC Module 3, specifically focusing on complex generics and sterile injectables.
With the Director preparing for maternity leave in April 2026, you will have the unique opportunity to step up, showcase your leadership, and provide essential backup to the Regulatory leadership team during a high-growth phase.
Key Responsibilities
Original Authoring:
Independently draft and author CMC Module 3 sections; this role goes beyond mere compilation and review.
Submission Leadership:
Lead the end-to-end lifecycle of ANDAs, supplements (CBE/PAS), and annual reports in compliance with GDUFA III standards.
Complex Generics:
Manage regulatory strategy for complex dosage forms, including sterile injectables and drug-device combination products.
Strategic Planning:
Evaluate product/process changes and recommend filing strategies and risk-based approaches.
Agency Interaction:
Prepare formal GDUFA III meeting packages and briefing documents for pre-submission and mid-cycle meetings.
Compliance:
Maintain Design History Files (DHF) and ensure alignment with Quality-by-Design (QbD) principles.
Required Qualifications
Education:
Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific field (Master’s degree preferred).
Experience:
5+ years of pharmaceutical Regulatory Affairs experience with a proven track record in
Small Molecule Generics .
Submission Expert:
Must have
independently authored
and filed at least 1–2 ANDAs since the 2022 regulatory standard updates.
Therapeutic Focus:
Direct experience with
Sterile Injectables
and/or complex dosage forms is required.
Technical Mastery:
Expert-level knowledge of eCTD software, MS Word, and Adobe Acrobat for document processing.
Why You’ll Love This Role
High Visibility:
Report directly to the Director and VP in a tight-knit team of 5, ensuring your work is recognized.
Prime Location:
Based in the heart of Northern-Central Jersey (Union County), offering a great balance of suburban life with easy access to the city.
Flexibility:
Enjoy a hybrid schedule with only two days required in-office (Tuesday/Wednesday, can be flexible on specific days of the week if needed).
Stability:
This is a Direct Hire position with a clear path for professional development and team leadership.
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Location:
Hybrid – Union County, NJ (Northern-Central Jersey) – 2 days onsite
Compensation:
Up to $120,000 + Benefits
Sponsorship:
H1B Transfers welcome (No New H1B or STEM OPT)
The Opportunity Are you a Regulatory Affairs professional who excels at the "writing" rather than just the "submitting"? We are seeking a
Senior Regulatory Affairs Associate
to join a growing, high-impact team in Union County. This is a critical role where you will serve as the
primary author
for CMC Module 3, specifically focusing on complex generics and sterile injectables.
With the Director preparing for maternity leave in April 2026, you will have the unique opportunity to step up, showcase your leadership, and provide essential backup to the Regulatory leadership team during a high-growth phase.
Key Responsibilities
Original Authoring:
Independently draft and author CMC Module 3 sections; this role goes beyond mere compilation and review.
Submission Leadership:
Lead the end-to-end lifecycle of ANDAs, supplements (CBE/PAS), and annual reports in compliance with GDUFA III standards.
Complex Generics:
Manage regulatory strategy for complex dosage forms, including sterile injectables and drug-device combination products.
Strategic Planning:
Evaluate product/process changes and recommend filing strategies and risk-based approaches.
Agency Interaction:
Prepare formal GDUFA III meeting packages and briefing documents for pre-submission and mid-cycle meetings.
Compliance:
Maintain Design History Files (DHF) and ensure alignment with Quality-by-Design (QbD) principles.
Required Qualifications
Education:
Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific field (Master’s degree preferred).
Experience:
5+ years of pharmaceutical Regulatory Affairs experience with a proven track record in
Small Molecule Generics .
Submission Expert:
Must have
independently authored
and filed at least 1–2 ANDAs since the 2022 regulatory standard updates.
Therapeutic Focus:
Direct experience with
Sterile Injectables
and/or complex dosage forms is required.
Technical Mastery:
Expert-level knowledge of eCTD software, MS Word, and Adobe Acrobat for document processing.
Why You’ll Love This Role
High Visibility:
Report directly to the Director and VP in a tight-knit team of 5, ensuring your work is recognized.
Prime Location:
Based in the heart of Northern-Central Jersey (Union County), offering a great balance of suburban life with easy access to the city.
Flexibility:
Enjoy a hybrid schedule with only two days required in-office (Tuesday/Wednesday, can be flexible on specific days of the week if needed).
Stability:
This is a Direct Hire position with a clear path for professional development and team leadership.
#J-18808-Ljbffr