System One Jobs

Regulatory Publishing Associate

Role Type: 12-month contract

Location: Florham Park, NJ - Hybrid

Schedule: Must be open to being Onsite 2-3 days/week

Must have:

• Must have publishing experience.

• Must be local to adhere to hybrid schedule.

  Description

  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 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 ongoing application maintenance in accordance with established timelines and submission dates in compliance with local and global regulatory requirements for the different application types (e.g., 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.

  • 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 to meet objectives in a timely manner.

  • Adept at identifying issues and propose solutions as necessary.

  • Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.