Manager, Regulatory Affairs CMC
Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with over 5,700 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive health (infertility), urology, gastroenterology, endocrinology, women's health (obstetrics/gynecology) and orthopaedics. Ferring's US operations employ approximately 800 people.
People Come First At Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.
The Regulatory Manager-CMC will handle all Fertility and Female Healthcare products, development and commercial.
- Lead the preparation, planning, coordination, execution and ongoing maintenance of CMC regulatory submissions
- Develop timelines for responses to FDA queries and ensure issues are addressed completely and in a timely manner; Prepare responses to complex questions and comments from FDA
- Communicate submission quality standards and requirements to project teams. Serve as the regulatory expert on cross functional teams to ensure quality submissions.
- Assess and manage RA CMC change controls process
- Enter submission data into the Regulatory Information Management system and update RA CMC Databases
- Maintain the CMC regulatory compliance for assigned products
- Perform regulatory reviews of Annual Product Reviews and other internal documents
- Manage projects guided by the Ferring USA Leadership Principles
- Perform duties as assigned by the Supervisor
- Bachelor's degree in a scientific field required; Masters or Ph.D a plus
- Minimum of 5-7 years of experience working with solid, liquid and parenteral dosage forms. Biological products knowledge is a plus.
- IND, NDA and BLA CMC experience is desirable.
- Working knowledge of drug development, FDA statutes, regulations and guidance documents
- Excellent organizational and interpersonal skills
- Excellent communication and presentation skills
- Proficient in Microsoft Office
- Working knowledge of eCTD submissions/format
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.
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