Job Summary

You will work closely with the Regulatory & Business Continuity Sr. Manager to ensure the compliance and completion of assigned activities and provide regulatory assessment in compliance with US FDA regulations, guidance, and applicable industry guidelines to internal and external stakeholders, and ensure the implementation. This position will be located at Princeton, NJ.

Area Of Responsibility

• Prepares the submissions (ANDAs, amendments, supplements, annual reports) to support commercial business and to be-in compliance to FDA regulations.
• Coordinate with all stake holders in preparing for deficiency responses for the submissions (ANDAs / supplements)
• Review CMC submission documents from regulatory perspective to meet scientific and technical requirements for acceptability and approvability by FDA
• Prepare, review and submit eCTD submissions and SPLs.
• Proactively assess all submissions for GAP analysis and summarize a report for anticipated deficiencies prior to submission to the FDA.
• Work cross-functionally/attend meetings with other sites/CMOs, project management and R&D departments.
• Maintain regulatory databases by regularly ensuring that the team members update the database information for completeness and ensuring correctness.
• Review change control process and coordinate with other departments to ensure timely implementation.
• Review and prepare RA assessments of change controls.
• Review and assess the changes notified by the suppliers of API (DMF updates), Excipients and packaging materials
• Prepare, review and finalize the SOPs for Regulatory Affairs department in-line with current practices and guidance updates from Agency.
• Renew the establishment registrations (ER) for the manufacturing and packaging sites and coordinate with other department in the company to ensure that the establishments and product fees (PDUFA program fee) are paid to the FDA before its deadline. Annual self-identification of sites.
• Coordinate with different sites for PDUFA / GDUFA/ OMUFA site registrations/ MDUFA annual registration.
• Prepare, review and submit the Controlled correspondence for concurrence from the Agency.
• Preparation and submission of request for PLAIRs
• Apply and manage for certificate of pharmaceutical products and ensure the Certificates are received from the FDA in the timely manner.
• Perform other duties as assigned

Work Conditions:

• Hybrid: 3 days in office; 2 days remote
• Document control/ document shelf arrangement

Physical Requirements:

• Able to operate computer/office machines
• Lift and/or move up to 20 pounds

Travel Estimate

Up to 20% (Office location at Princeton, New Jersey however would require travel to Billerica, Massachusetts)

Education and Job Qualification

• Bachelor's degree in Pharmacy, Chemistry or life science is required. Advanced degree in Regulatory Affairs or pharmaceutical science preferred.
• Strong verbal and written communication and interpersonal skills.
• Creative, flexible, and innovative team player.
• Ability to work in a fast paced, constantly changing work environment.
• Proven ability to handle multiple projects and meet timelines.
• Ability to quickly learn different new/updated electronic software applications.

Experience

• 5-8 years of related Pharmaceutical Industry experience preferably in Regulatory Affairs
• Must be highly organized and have the ability to meet critical timelines
• Very strong organizational skills that is necessary to manage and multi-task various activities.
• Experience and knowledge in the preparation of major regulatory submissions and supportive documents.
• Having knowledge of FDA eCTD submission standards for US Applications
• Experience using change control systems, ideally Track-Wise, required
• Ability to use Microsoft Office Suite professionally/ Adobe Acrobat Professional
• Ability to work cross-functionally to attain goals

The presently-anticipated base compensation pay range for this position is $102,500 to $125,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. 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.