RA Specialist

Sandoz•Princeton, FL

6d•Hybrid

About The Position

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! 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.

Requirements

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
Demonstrated ability to independently manage regulatory submissions and collaborate effectively across functional areas

Nice To Haves

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

Responsibilities

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.