Job Description

Job Title - Regulatory Operations Publisher

Location - Florham Park, NJ

Duration - 12+ Months Contract - Onsite

Detailed Description:

Responsibilities

• Support in the preparation and submittal of regulatory applications and on‐going application maintenance in accordance with established timelines and submission dates in compliance with local and global regulatory requirements for the different application types (eg, IND, NDA/BLA, MAA, CTA, DMF).
• Ensure consistency across regulatory submission documents following the regulatory style guide (i.e. formatting, reviewing, and submissions).
• Provide technical expertise to cross-functional teams on structure of compliant documents for electronic submissions.
• Coordinate with cross-functional teams, including Regulatory Affairs, Clinical Development, and Quality Assurance, to obtain the necessary information to ensure timely submission of regulatory documents.
• Conduct review of published submissions to ensure consistency and compliance with regulatory requirements.
• Perform quality control checks on documents to ensure accuracy and completeness, as well as resolve any issues that arise.
• Execute regulatory information management tasks including file transfer, storing, tracking, and archiving of regulatory submissions.
• Maintain knowledge of local regulatory submission requirements.
• Ensure adherence to Company Standard Operating Procedures.
• Maintain compliance with current Good Manufacturing Practices (cGMPs), government regulations, industry standards, approved specifications, and Company procedures and directives.
• Supports in the review of Regulatory Operations processes (SOPs, work instructions, checklists, templates) for preparing submissions and regulatory information management.
• Other duties as assigned.

Minimum Job Requirements

Qualifications

• Minimum of 1-2 years of experience required within a pharmaceutical regulatory environment, including eCTD publishing of INDs and NDAs. Prior knowledge of CTAs/MAAs a plus.
• Bachelor’s degree preferred
• Acquired knowledge of nonclinical, clinical, CMC, DMF, and labeling/SPL submission documents.
• Familiar with regulatory guidelines, such as FDA, EMA, MHRA, and Health Canada. Knowledge and understanding of relevant Health Authority guidance and other regulatory requirements

Job Tags

Similar Jobs