Regulatory Operations Associate

4 weeks ago

Florham Park, United States Planet Pharma Full time

Immediate need for a Regulatory Operations Associate. Prefer someone local to Florham Park, NJ.

Looking for the following experience -

  • Publishing, requirements, bookmarks, Use Docubridge publishing tool, understanding lifecycle of documents, partner with RAs, QC
  • Docubridge experience HIGHLY PREFERRED
  • Publishing eCTD, FDA guidance for submissions
  • 3-5 years experience target - need to be able to hit the ground running, strong background in Regulatory Operations, Publishing and document management

The Regulatory Operations Associate will support in the preparation and submission of electronic regulatory documents through the FDA, EMA, MHRA, and Health Canada Electronic Submission Gateways (ESG), as well as, prepare and file non-eCTD submissions to ensure compliance with applicable laws and regulations. This includes formatting and publishing regulatory documents, managing document tracking and version control, maintaining a thorough understanding of regulatory requirements, collaborating with cross-functional teams, and identifying opportunities for process improvement.

The overall scope of the Regulatory Operations Associate is to ensure the timely and accurate submission of our global regulatory documents and maintain compliance with regulatory requirements. This role involves communicating with cross-functional teams to ensure submission related activities are formatted, remediated, QCd and archived consistently according to clients standard operating procedures. Responsibilities

  • Below is a list of the main activities needed to fulfill the requirements of the role. It is not meant to be a comprehensive list, but rather, provide an overview of the specialized skills and expertise required: 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 format, style, and 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 submission documents/correspondence.
  • Maintain knowledge of local and global 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

  • Bachelors degree or a 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.
  • 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
  • Proficiency in using:
  • Software and tools for document formatting, publishing, submissions, and tracking (i.e. MS Office, Acrobat Adobe, ISI Toolbox, and at least one eCTD publishing system)
  • Veeva Vault RIM, ESG Gateway, Syncplicity (EMA Gateway), and MHRA Portal
  • Capable of reviewing documentation with a high degree of attention to detail.
  • Effective communicator adept at communicating with cross-functional teams, regardless of level, and regulatory agencies if required.
  • Adept at handling and prioritizing multiple projects/activities simultaneously while ensuring all deadlines are met.
  • Ability to work collaboratively with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance in a team?oriented environment.
  • Capable of managing time effectively, prioritize tasks in order to meet objectives in a timely manner.
  • Adept at identifying issues and propose solutions as necessary.

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