RA Specialist

sandoz; Princeton (NJ); Hybrid; USD 94,000 - 174,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

401(k) match

Generous PTO

Hybrid work policy

Job summary

Sandoz is seeking a Regulatory Specialist, Regulatory Affairs CMC to manage regulatory submissions such as ANDAs, amendments, and DMFs. This role collaborates with cross-functional teams to ensure compliance with FDA regulations and company procedures, located at the Princeton, NJ headquarters with hybrid work up to 50% remote.

The candidate should have 3–5 years in Pharmaceutical Regulatory Affairs, strong communication, and the ability to handle multiple projects with minimal supervision. U.S.

Qualifications

• Bachelor's degree in a scientific field.
• 3–5 years in Pharmaceutical Regulatory Affairs.
• Ability to manage multiple projects and deadlines.
• Experience working in cross-functional teams.
• Strong communication and leadership abilities.

Responsibilities

• Review, prepare, and maintain regulatory submissions including ANDAs, amendments, supplements.
• Prepare and maintain Type II and Type V DMFs, amendments, annual reports.
• Prioritize workload with minimal supervision.
• Collaborate with internal teams and external partners for compliance.
• Review labeling change control and approve revised documents.
• Interact with FDA regarding submissions.
• Maintain regulatory records and document management systems.

Skills

Regulatory submissions

FDA liaison

Cross-functional teamwork

Project management

Regulatory compliance

Education

Bachelor's degree in a scientific field

Advanced degree

Job description

Job Description Summary

The Regulatory Specialist, Regulatory Affairs CMC, is responsible for preparing, submitting and maintaining regulatory submissions including ANDAs, amendments, supplements, annual reports, and responses to FDA deficiencies. This role partners with cross-functional teams to support submission activities, regulatory assessments, and compliance with FDA regulations and company procedures.

Job Description

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally.

Join us, the future is ours to shape!

Position Location:

This position will be located at the Princeton, NJ US Headquarters site. Our Sandoz flexible hybrid working approach allows US office-based employees to work up to 50% of their monthly workday remotely. This role will not have the ability to be located remotely.

Must be authorized to work in the U.S. U.S. work visa sponsorship is not available for this role now or in the future.

Major Accountabilities / Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Independently reviews, prepares, and maintains regulatory submissions including ANDAs, amendments, supplements, annual reports, and responses to FDA deficiencies.
• Prepares, submits, and maintains Type II and Type V DMFs, amendments, annual reports, letters of authorization and responses to FDA deficiencies.
• Prioritizes workload. Receives little supervision for most assignments. Receives general instructions for non-standard analyses and projects.
• Collaborates with functional business units and external partners to ensure regulatory compliance and timely submissions.
• Reviews Labeling Change Control requests and approves revised labeling documents, which may include physician and patient package inserts as well as various types of container labels.
• Interacts with FDA regarding submissions.
• Performs regulatory assessments of change controls.
• Maintains regulatory records, databases, and document management systems in accordance with company procedures.

Key Performance Indicators:

• On-time submission of assigned regulatory filings
• Timely closure of regulatory commitments and FDA requests
• Compliance with regulatory requirements
• Timely assessment and closure of change controls
• High quality submissions with minimal FDA Deficiencies

Key Capabilities Required:

Regulatory Submission: Ability to prepare, review, and maintain regulatory submissions in accordance with FDA regulations and company procedures.

Organization & execution : Ability to prioritize workload, manage multiple projects simultaneously, and meet regulatory deadlines with minimal supervision.

Agency & Stakeholder communication : Effectively manages communications with FDA, external partners, and functional business units.

Analytical Thinking & Problem Solving: Ability to identify regulatory issues, evaluate information, and recommend solutions

CMC Technical Expertise: Strong understanding of pharmaceutical manufacturing processes.

What you'll bring to the role:

Education & Experience (Required):

Essential Qualifications

• Bachelor's degree in a scientific related field
• 3-5 years Pharmaceutical Regulatory Affairs
• Problem solving skills
• Ability to manage multiple projects and regulatory deadlines simultaneously
• Experience working effectively in cross-functional teams
• Strong communication skills
• Good judgement and leadership ability
• Essential skills, Demonstrated ability to independently manage regulatory submissions and collaborate effectively across functional areas

Preferred Requirements:

• Advanced degree (MS, Pharm D, or equivalent) in a scientific discipline.
• Experience with ANDA and DMF filings

Travel Requirements:

Travel not required

You’ll Receive:

• Sandoz offers a generous employee benefits package that includes a competitive salary, health insurance coverage for medical, prescription drugs, dental and vision, a generous company match for retirement savings accounts, and generous paid time off. We also follow a hybrid work policy that combines a mix of in-person and remote work to allow our employees flexibility.

The pay range for this position at commencement of employment is expected to be between $ 93,800 - $ 174,200 USD/year ; however, while salary ranges are effective from 1/1/26 through 12/31/26, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial