RA Specialist

The Regulatory Specialist, Regulatory Affairs CMC, is responsible for preparing, submitting and maintaining regulatory submissions and Drug Master Files (DMFs) to support generic pharmaceutical products throughout their lifecycle. This role partners with cross-functional teams to support submission activities, regulatory assessments, and compliance with FDA regulations and company procedures.

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!

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.

• 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.

• 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

• 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.

• 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

• Advanced degree (MS, Pharm D, or equivalent) in a scientific…