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Senior Regulatory Affairs Associate

Actalent · Morristown, NJ · 5 days ago
On-siteLegal$50–$60/hrContract

Summary

This position is responsible for helping to plan, schedule and coordinate regulatory submissions in adherence with technical document standards that are fully compliant with FDA and ICH requirements. Serves as system administrator for Alvogen's US Regulatory electronic document management system and acts as the primary publisher of US Regulatory submissions.

Schedule

Monday–Friday, 8:00 AM – 4:30 PM (flexible start time). Hybrid arrangement: onsite Tuesday through Thursday; Monday and Friday work from home.

Location

Morristown, New Jersey. Reports to the Director, Regulatory Affairs (or equivalent).

Responsibilities

  • Publishes US Regulatory Submissions to the FDA: NDAs, INDs, ANDAs, Amendments, Supplements, Annual Reports, PADERS, etc., on time.
  • Works with the Manager and document authors across all disciplines to develop and maintain a comprehensive set of e‑submission document templates fully compliant with FDA and ICH document requirements.
  • Maintains efficient tracking mechanisms for all regulatory information including archiving and storage of both electronic and hard‑copy records.
  • Works on all aspects of document workflows associated with submission authoring, review, compilation and publishing for various submission types.
  • Assists in monitoring and maintains familiarity with evolving and/or new regulatory e‑submission requirements; ensures all functional disciplines are apprised of changes and trained accordingly under the direction of the Manager of Regulatory Operations.
  • Helps to author, develop and/or collaborate on SOPs and Work Instructions for the Publishing and Electronic Document Management System.
  • Independently tracks and manages all correspondence between Alvogen and government agencies, including phone calls, emails, and relevant documents.
  • Accurately updates and maintains trackers, spreadsheets and databases in a timely manner.
  • Meticulously meets corporate and departmental filing objectives with strict adherence to FDA/ICH requirements.
  • Monitors and maintains the highest level of submission standards.

Qualifications

  • Minimum of a Bachelor's degree in a life science (advanced degree preferred).
  • Minimum of 5 years in the pharmaceutical industry, with 3–4 years in regulatory affairs.

Skills

  • Proficient in Microsoft Word, Excel, PowerPoint; Access database proficiency a plus.
  • Knowledge of eCTD publishing systems, EDMS technology and related publishing tools.
  • Working knowledge of US FDA (OGD/CDER) e‑submission requirements.
  • Knowledge/experience with CMC regulatory requirements.
  • Excellent verbal and written communication skills.
  • Highly motivated, results‑driven individual with unyielding predisposition to detail, accuracy and clarity.
  • Performs duties with the highest ethical standards, delivering only high‑quality, compliant submissions to FDA.
  • Must be able to work independently and possess excellent decision‑making and problem‑solving skills.

Pay

Hourly rate: $50.00 – $60.00. Individual compensation within this range depends on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job‑related factors.

Benefits

  • Medical, dental & vision
  • Critical Illness, Accident, and Hospital coverage
  • 401(k) Retirement Plan (pre‑tax and Roth post‑tax contributions available)
  • Life Insurance (Voluntary Life & AD&D for employee and dependents)
  • Short and long‑term disability
  • Health Spending Account (HSA)
  • Transportation benefits
  • Employee Assistance Program
  • Time Off/Leave (PTO, Vacation or Sick Leave)

Contract Details

Contract position based in Morristown, NJ. Anticipated closing date: November 5, 2026. Hybrid workplace in Morristown, NJ.

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