Regulatory Affairs Associate

Regulatory Affairs Specialist

The Regulatory Affairs Specialist ensures a controlled documentation system, record retention, and information services, including electronic records retention processes, are maintained in accordance with regulatory requirements. This role is crucial in ensuring compliance with regulatory agency requirements, maintaining the technical and non-technical documentation change system, and enforcing documentation formatting standards and operating procedures.

Responsibilities

• Ensure the smooth running of the Drug Regulatory Affairs Department by providing professional secretarial services and assistance.
• Contribute to the achievement of functional objectives by applying basic principles, theories, and professional concepts.
• Maintain and manage controlled documentation systems, ensuring proper record retention and compliance with regulatory requirements.
• Interpret and enforce documentation formatting, standards, policies, and operating procedures.
• Identify submission components, communicate documentation standards, and coordinate the assembly of regulatory dossiers.
• Analyze and evaluate data, extract pertinent information, and prepare information abstracts and executive summaries.
• Maintain extensive knowledge of product information and maintain continuous contact with local and regional customers.

Essential Skills

• Strong knowledge of regulatory affairs, regulatory submission, documentation, and records management.
• Ability to maintain controlled documentation systems and enforce formatting and procedural standards.
• Understanding of regulatory agency requirements and the ability to support the preparation and coordination of regulatory submissions and dossiers.
• Attention to detail and strong organizational skills.

Additional Skills & Qualifications

• Experience in operations management and execution.
• Ability to collaborate across boundaries and work in cross-cultural environments.
• Adherence to company policies and guidelines.
• Experience in project management and stakeholder feedback.

Work Environment

This position is part of one of the world's largest manufacturers of generic and biosimilar medicines. The company focuses on expanding in GLP-1 therapeutics, ophthalmology, and autoimmune diseases. It has a strategic emphasis on generics and biosimilars, representing a significant portion of its sales, and is a pioneer in the biosimilar space.

Job Type & Location

This is a Contract position based out of Princeton, New Jersey.

Pay and Benefits

The pay range for this position is $55.00 - $55.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the 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)

Workplace Type

This is a fully onsite position in Princeton, NJ.

Application Deadline

This position is anticipated to close on Oct 3, 2025.