Regulatory Operations and eCTD Publishing

Location: Berkeley Heights, NJ (Remote, hybrid, or on-site)
Work Schedule: Up to 35 hours per week, generally spread across five weekdays with flexibility; availability may be required during critical submission deadlines.
Duration: 3-month contract
Compensation: $45/hr

Position Summary:
We are seeking a highly experienced Regulatory Operations professional to join our team on a 6-month contract. This remote, hybrid, or onsite role focuses on providing expert eCTD publishing support within the generic pharmaceutical space. The successful candidate will independently compile, publish, track, and maintain U.S. FDA regulatory submissions, with a particular emphasis on ANDAs and Modules 4 and 5. The ideal individual possesses significant experience in a regulatory affairs environment supporting generic pharmaceutical products, demonstrating the ability to manage multiple submissions and deadlines simultaneously. This role offers an excellent opportunity to contribute to critical regulatory processes with minimal supervision, ensuring compliance and accuracy in all submissions.

Key Responsibilities:

• Independently compile and publish U.S. FDA regulatory submissions, including ANDAs, amendments, and Modules 4 and 5, ensuring adherence to eCTD standards.
• Manage the entire document workflow, including authoring coordination, review, compilation, publishing, and archiving of regulatory documents.
• Maintain accurate electronic and hard-copy regulatory records for all submissions.
• Track and manage correspondence and communication between the company and the FDA.
• Update and maintain submission trackers, spreadsheets, and regulatory databases to ensure data accuracy and timeliness.
• Monitor and uphold high standards for eCTD publishing quality and compliance.
• Collaborate effectively with CMC, labeling, and regulatory operations teams to support submission readiness.
• Oversee multiple ongoing products and upcoming deadlines, prioritizing tasks efficiently.
• Perform additional regulatory operations duties as required to support departmental goals.

Required Qualifications:

• Minimum of 5 years of experience in the pharmaceutical industry.
• At least 3–4 years of hands-on experience specifically in regulatory affairs operations, with a focus on eCTD publishing.
• Proven experience managing and publishing regulatory submissions for ANDAs supported by Modules 4 and 5.
• Strong understanding of U.S. FDA OGD/CDER electronic submission requirements.
• Proficiency in Microsoft Word, Adobe Acrobat, Microsoft Office Suite, and eCTD publishing software.
• Excellent written and verbal communication skills.
• Demonstrated ability to independently handle multiple deadlines and submissions with minimal oversight.

Preferred Skills & Experience:

• Prior experience working within a generic pharmaceutical company.
• Experience managing multiple products or programs concurrently.
• Strong skills in submission tracking, document management, and regulatory records maintenance.
• Proven ability to collaborate with CMC and labeling teams effectively.
• Ability to thrive in a fast-paced environment with shifting priorities.
• Local candidates or those willing to work onsite or hybrid in Berkeley Heights, NJ are preferred, although remote candidates are fully eligible.

At Premier Talent Partners, we are a people-centered recruitment firm with a strong focus on skills-based hiring. We specialize in placing individuals in roles ranging from entry-level to VP level across various fields, including Customer Success, Sales & Marketing, Finance & Accounting, Administrative, HR, Operations, and Technology. Our expertise spans contract/temporary, temporary-to-permanent, permanent, and employer-of-record services, and we are committed to equitable & inclusive hiring practices on a national scale.

Benefits: Eligible employees may have access to benefits including medical, dental, vision, paid time off, paid holidays, and other company-sponsored programs, subject to eligibility requirements. (If this is a contract role: This position is not eligible for company-sponsored benefits unless otherwise required by law.)

If you have an interest in exploring other positions similar to this one, please note that compensation ranges and benefits offerings may vary by role and assignment.

We do consider applications from qualified candidates with prior arrests and conviction records, in accordance with applicable regulations.

Work authorization: At this time, we are unable to offer employment sponsorship.

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