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Regulatory Operations Associate (Consultant)

Florham Park, NJ 07932

Posted: 06/10/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 607687 Is job remote?: No Country: United States

Job Description



Location: Florham Park, NJ - Ideally local, open to REMOTE EST

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, QC’d and archived consistently according to Shionogi’s 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.
Supervisory | Decision-Making Authority
  • N/A
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.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Florham Park, NJ

Ready to seize new career opportunities in bustling Florham Park, New Jersey? Nestled in Morris County, this vibrant area offers a perfect blend of urban amenities and suburban charm. With its proximity to New York City, top-notch schools, and a thriving business community, Florham Park provides an ideal backdrop for professional growth. Explore job listings in this picturesque region known for its historic landmarks like the Frelinghuysen Arboretum, varied cuisine options, and rich cultural scene featuring the Morris Museum and Theatre. Don't miss out on joining this dynamic community; your dream career awaits!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.