Senior Regulatory Affairs Associate

Job Description

Job Description

Job Title: Senior Associate, Regulatory Operations

Schedule: M-F from 8 AM to 4:30 PM (Flexible start time)

This role would be onsite from Tuesday to Thursday with Monday + Friday WFH

SUMMARY OF POSITION

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 system administrator for Alvogens US Regulatory electronic document management system. He/she will serve as the primary publisher of US Regulatory submissions.   

ORGANIZATION STRUCTURE

The Senior Associate, Regulatory Operations reports into the Director, Regulatory Affairs or equivalent and is based in Morristown, New Jersey.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

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

QUALIFICATIONS

• Minimum of a Bachelors 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. 

Job-Specific Competencies/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.

Job Type & Location

This is a Contract position based out of Morristown, NJ.

The pay range for this position is $50.00 - $60.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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)

This is a Contract position based out of Morristown, NJ.

This position is anticipated to close on Nov 5, 2026.

This is a hybrid position in Morristown,NJ.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.