Regulatory Affairs- Manager-CMC

Lupin Pharmaceuticals•Somerset, NJ

9d•$107,000 - $140,000

About The Position

Overview Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women’s health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of Fifteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way. Responsibilities The Manager, Regulatory Affairs – CMC will lead and oversee all Chemistry, Manufacturing, and Controls (CMC) regulatory activities related to ANDAs, supplements, and amendments. The role involves authoring and reviewing CMC sections, evaluating change controls, coordinating cross-functional activities, interacting with regulatory agencies, and providing leadership, training, and guidance to the regulatory affairs team. The position ensures high-quality submissions that meet global regulatory standards and support the company’s product portfolio.

Requirements

Master’s degree in pharmacy, chemistry, pharmaceutical sciences, or related field; advanced degree preferred
4-6 years of experience in regulatory affairs focusing on CMC for ANDAs, supplements, and amendments in the pharmaceutical industry
Proven experience in authoring, reviewing, and managing CMC sections for regulator submissions
Strong knowledge of FDA and global regulatory requirements for generics, supplements, and post-approval changes.
Demonstrated team leadership skills, including mentoring, coaching, and managing regulatory affairs professionals.
Excellent cross-functional collaboration, analytical, and problem-solving skills.
Strong written and verbal communication skills for drafting regulatory documents and interacting with agencies.
Ability to manage multiple projects, prioritize tasks, and meet deadlines in a fast-paced environment.

Responsibilities

Lead the preparation, authoring, and review of CMC sections for ANDAs, supplements, and amendments, ensuring compliance with regulatory requirements.
Review technical data and documentation, providing regulatory and scientific assessments for submissions.
Evaluate change controls, manufacturing deviations, and post-approval changes for regulatory impact.
Coordinate with cross-functional teams, including Quality, Manufacturing, Analytical Development, and R&D, to ensure accurate and timely submission of regulatory documents.
Monitor regulatory guidance, industry standards, and FDA/other agency expectations relevant to ANDAs and post-approval changes.
Establish and maintain standard operating procedures (SOPs) and best practices for CMC submissions and change control assessments.
Participate in internal audits and training sessions.
Ensure timely responses to the Agency queries as required.
Assess and determine regulatory reporting categories for CMC changes in accordance with applicable regulations and guidance.
Prepare, review and submit post-approval supplements including: Annual Reports, CBE-0 and CBE-30 Supplements, Prior Approval Supplements (PAS)
Prepare, review and submit Amendments and notifications
Regulatory Support for site transfers, process changes, specification updates, method validations, equipment changes, and packaging modifications.
Track and manage lifecycle submissions and approvals.
Maintain regulatory files and databases.
Ensure version control and archival of submission documents
Foster a culture of continuous improvement, knowledge sharing, and compliance within the team.