Senior Manager, CMC Regulatory Affairs

Location: Parsippany

As a privately-owned, specialty healthcare company, Ferring focuses on developing life-changing innovations that help people live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale while remaining agile and true to our 'people first' philosophy. Built on a 70-year commitment to science and research, Ferring is relentless in pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease.

Responsibilities:

• Regulatory Intelligence: maintain database; periodic research, interpretation of regulatory guidance documents, review of draft guidance documents for impact to Ferring; consolidate comments from stakeholders;- Attend applicable meetings; develop SOP.
• Prepare and review CMC sections for product submissions.
• Update and maintain the following folders.
• CMC Summaries; NDA Supplements; Change control Database.
• Manage CMC Databases.
• Manage regulatory plans for drugs in development.
• RA CMC Operation.
• Prepare and maintain CMC submission templates/forms; CMC Notifications, RIMs entries, EMT and Metrics reporting.
• Manage projects guided by the Ferring USA Leadership Principles.
• Perform duties as assigned by the Supervisor.

Requirements:

• Bachelor's degree in a scientific field required;
• Minimum of 10 years' experience in the pharmaceutical industry.
• Minimum of 5-10 years of relevant experience withparenteral and biological product CMC submissions is required.
• IND, NDA & BLA experience.
• Working knowledge of drug development, FDA statutes, regulations and guidance documents.
• Attendance and participation in all assigned team meetings.
• Excellent organizational and interpersonal skills.
• Excellent communication and presentation skills.
• Proficient in Microsoft Office.
• Working knowledge of eCTD submissions/electronic format.

Prospective new hires for this position must be fully vaccinated against COVID-19 as a condition of employment. Vaccine verification will be required on your start date unless an exemption has been approved by the Company as a medical or religious accommodation.

Join our team and you'll become part of a close-knit family - one in which you'll be listened to and your contributions valued. Surrounded by like-minded people, you'll have the support to achieve more. So if you love to come up with new ways to make a positive difference and see them through, welcome to the team.

We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We maintain a drug-free workplace and perform pre-employment substance abuse testing.