Job Description SummaryThe 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.
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:Required Qualifications:Education & Experience (Required):- Bachelor's degree in a scientific related field
- 3-5 years Pharmaceutical Regulatory Affairs
- 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, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
On September 30, 2021, Sandoz entered into a 5-year Corporate Integrity Agreement. Certain positions will have responsibilities to support the execution and adherence to CIA obligations, CIA-related deliverables, and any relevant audit, monitoring or Independent Review Organization (IRO) remediation.
Sandoz - Notice at Collection to Employees Applicants 4.15.24[16].pdf
Salary Range$93,800.00 - $174,200.00
Skills DesiredAnalytical Skill, Clinical Trials, Collaboration, Detail-Oriented, Lifesciences, Project Planning, Regulatory Compliance
