Senior Regulatory Submissions Specialist

Actalent; United States; Híbrido; USD 69 000 - 83 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, dental & vision

401(k) retirement plan

Life Insurance

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Time Off / PTO

Resumo da oferta

Actalent is seeking a Senior Associate, Regulatory Operations in Morristown, NJ. The role focuses on planning, scheduling, and coordinating US regulatory submissions to FDA/ICH, publishing and maintaining templates, and serving as EDMS system administrator.

The position requires 5 years in pharma with 3–4 years in regulatory affairs, plus strong communication and problem-solving skills. Hybrid schedule with Tue–Thu onsite and Mon/Fri WFH, contract role.

Qualificações

• Bachelor's degree in life science
• Minimum of 5 years in the pharmaceutical industry with 3–4 years in regulatory affairs
• Experience with FDA/ICH e-submission requirements
• Proficiency in eCTD publishing systems and EDMS
• Strong written and verbal communication skills
• Ability to work independently and manage multiple submissions

Responsabilidades

• Publish US Regulatory Submissions to FDA (NDAs, INDs, ANDAs, amendments, supplements) on time
• Develop and maintain e-submission document templates compliant with FDA/ICH
• Maintain trackers and archiving for electronic and hard copy records
• Manage submission authoring, review, compilation and publishing processes
• Stay updated on evolving regulatory e-submission requirements and train the team
• Help author SOPs and Work Instructions for the publishing system
• Track all correspondence with government agencies and ensure timely updates
• Ensure high-quality, compliant submissions meet filing objectives

Conhecimentos

Regulatory operations

eCTD publishing

EDMS administration

FDA regulatory knowledge

Attention to detail

Independent worker

Communication skills

Formação académica

Bachelor's degree in life science

Advanced degree preferred

Ferramentas

Microsoft Word

Excel

PowerPoint

Access

Descrição da oferta de emprego

Actalent is seeking a Senior Associate, Regulatory Operations in Morristown, NJ. The role focuses on planning, scheduling, and coordinating US regulatory submissions to FDA/ICH, publishing and maintaining templates, and serving as EDMS system administrator.

The position requires 5 years in pharma with 3–4 years in regulatory affairs, plus strong communication and problem-solving skills. Hybrid schedule with Tue–Thu onsite and Mon/Fri WFH, contract role.