Job Title: Regulatory Affairs Associate

Job Description

We are seeking a highly skilled and motivated Regulatory Affairs Associate with extensive experience in authoring ANDA submissions, including all modules 1-5. The ideal candidate will have hands-on experience responding to FDA queries and a background in the pharmaceutical industry, specifically in regulatory affairs. This role requires a strong understanding of FDA guidelines and the ability to manage complex submissions while ensuring compliance and timely approvals.

Responsibilities

• Oversee and manage submission compilation while maintaining adherence to FDA standards and internal requirements.
• Interact effectively with functional business units to coordinate and facilitate procurement of documentation required for submissions, ensuring departmental timelines are met.
• Represent regulatory affairs in project team meetings, providing regulatory guidance and perspective to team members to meet scheduling timelines and resolve technical issues.
• Independently author, compile, and review high-quality, complex, original new ANDAs, NDAs, Amendments, Supplements, Annual Reports, and responses to inquiries from FDA to ensure expeditious approvals.
• Review technical documents for accuracy and acceptability for use in new ANDAs, NDAs, 505(b)(2), Amendments, Supplements, Annual Reports, and other required FDA filings.
• Interface with project team members and functional departmental representatives to obtain documentation and establish timelines to ensure complete and accurate submissions are prepared according to plan.
• Review Modules in eCTD and verify proper hypertext linking.
• Review and sign-off on change control documentation, assessing changes and their impact on the business based on an advanced understanding of regulatory guidelines and applicable federal laws.
• Assist in formulating sound strategies in support of submission goals.
• Participate in the development and maintenance of regulatory systems, processes, checklists, and procedures to facilitate consistency.
• Independently track and manage all correspondence between the company and government agencies, including phone calls, emails, and relevant documents.
• Accurately update and maintain spreadsheets and databases in a timely manner.
• Perform other duties as assigned.

Essential Skills

• Minimum of a Bachelor's Degree in a life science.
• Minimum of 5 years in the pharmaceutical industry with 3-4 of those years in regulatory affairs.
• Excellent verbal and written communication skills.
• In-depth knowledge and understanding of FDA guidelines with proven ability to apply these to work output.
• Strong critical and logical thinking skills with the ability to analyze problems and recommend solutions.
• Effective communication of regulatory requirements and strategies to internal and external partners.
• Sound judgment and the ability to make appropriate decisions on regulatory activities and work outputs.
• Ability to prioritize competing tasks in a fast-paced and dynamic environment.
• Highly motivated, results-driven, with a strong attention to detail, accuracy, and clarity.
• Working knowledge of US FDA (OGD/CDER) e-submission requirements.
• Experience with CMC regulatory requirements.

Additional Skills & Qualifications

• Experience in generic pharmaceuticals is preferable as it indicates experience with complete submissions.

Work Environment

This position is hybrid, with 3 days on-site in Morristown, New Jersey. The role reports to the Director of Regulatory Affairs. Remote work will be considered.

Pay and Benefits

The pay range for this position is $90000.00 - $115000.00/yr.

Hybrid work environment
- good team good manager

Workplace Type

This is a hybrid position in Parsippany-Troy Hills,NJ.

Application Deadline

This position is anticipated to close on Apr 30, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $90,000 - $115,000