Job Title: Senior Associate, Regulatory Operations/CMC

Job Description

We are seeking a highly motivated and detail-oriented Senior Associate, Regulatory Operations/CMC to join our team. The ideal candidate will have extensive experience in the pharmaceutical industry, particularly in regulatory affairs, and will be responsible for ensuring high-quality submissions to the FDA. This role involves collaboration with various disciplines to develop and maintain e-submission document templates, track regulatory information, and ensure compliance with FDA and ICH requirements.

Responsibilities

• Publish US Regulatory Submissions to the Food and Drug Administration (NDAs, INDs, ANDAs, Amendments, Supplements, Annual Reports, PADERS, etc.) on time.
• Work with the Manager and document authors across all disciplines to develop and maintain a comprehensive set of e-submission document templates compliant with FDA and ICH document requirements.
• Maintain efficient tracking mechanisms for all regulatory information, including archiving and storage of both electronic and hard copy records.
• Handle all aspects of document workflows associated with submission authoring, review, compilation, and publishing for various submission types.
• Assist in monitoring and maintaining familiarity with evolving and/or new regulatory e-submission requirements and ensure all functional disciplines are apprised of changes and trained accordingly.
• Help author, develop, and collaborate on SOPs and Work Instructions for the Publishing and Electronic Submission Management System.
• Independently track and manage all correspondence between the company and government agencies, including phone calls, emails, and relevant documents.
• Accurately update and maintain trackers, spreadsheets, and databases in a timely manner.
• Meticulously meet corporate and departmental filing objectives with strict adherence to FDA/ICH requirements.
• Monitor and maintain the highest level of submission standards.
• Train new employees in submission processes and procedures.
• Review technical documents for accuracy and acceptability for use in ANDAs, NDAs, Amendments, Supplements, Annual Reports, and other required FDA filings to ensure high-quality submissions.
• Independently author, compile, review, and submit high-quality Amendments, Supplements, and Annual Reports.
• Perform other related duties as assigned.

Essential Skills

• Proficient in Microsoft Word, Excel, PowerPoint. Access database proficiency is a plus.
• Knowledge of eCTD publishing systems, EDMS technology, and related publishing tools.
• Working knowledge of US FDA (OGD/CDER) e-submission requirements.
• Knowledge and experience with CMC regulatory requirements.
• Excellent verbal and written communication skills.
• Highly motivated and results-driven with a strong attention to detail, accuracy, and clarity.
• Commitment to performing duties with the highest ethical standards.
• Ability to work independently and possess excellent decision-making and problem-solving skills.
• Effectively prioritize competing tasks in a fast-paced and dynamic environment.
• Strong critical and logical thinking skills with the ability to analyze problems and recommend solutions.

Additional Skills & 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 of those years in regulatory affairs.

Work Environment

This position operates in a hybrid work environment, with 3 days on-site. The role reports to the Manager/Director of Regulatory Affairs or equivalent and is based in Morristown, New Jersey.

Pay and Benefits

The pay range for this position is $100000.00 - $135000.00/yr.

Hybrid work environment
- good team good manager

Workplace Type

This is a hybrid position in Morristown,NJ.

Application Deadline

This position is anticipated to close on Apr 1, 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 : $100,000 - $135,000