Celgene Manager, CMC Regulatory Affairs in Summit, New Jersey
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
As a Manager CMC Regulatory Affairs, you will develop and oversee the execution of CMC regulatory strategies and regulatory submissions (IND, BLA, MAA) for Juno Therapeutics CAR T cell, TCR, Gene Editing cell/gene therapy human biological products as well as critical raw materials such as vectors and other novel technologies in the US and ROW. You will manage and/or provide support to other CMC RA staff in the creation of CMC submissions to regulatory authorities (FDA, EMA, PMDA, CFDA); and to support their approval. You will provide regulatory support and guidance on CMC post approval changes to US and ROW marketed products.
· Regulatory accountability includes North Americas, EU, Japan, and China including liaison with regulatory agencies.
· Provide support in communication with regulatory authorities (FDA, EMA, PMDA, CFDA) on CMC regulatory issues; lead CMC topics during regulatory meetings.
· Provide CMC regulatory guidance on late stage development projects (as member of CMC Subteams), and for post approval CMC changes; define CMC regulatory submission strategies during development and post approval.
· Evaluate CMC regulatory documents from technical departments in R&D/Operations/Quality and provide guidance for submission to FDA as well as international regulatory authorities.
· Provides support for global CMC submissions, post approval CMC supplements, and support for their approval by regulatory authorities.
· Provide support to Business Development for the potential in - licensing of compounds and provide CMC regulatory assessment.
· Maintains awareness and has critical expertise with ICH, FDA and EU guidelines related to CMC regulatory topics.
· Interface with other core functions at Juno Therapeutics including Product Development, Operations, Quality, and Information Technologies.
· Effect timely and appropriate regulatory management of CMC changes to registered products in accord with the Change Management Procedure.
· Review Product Complaints and GMP Deviations as needed in order to determine Biological Product Deviation Reporting (BPDR) requirements and provide regulatory assessments.
· Responsible for drafting and submitting BPDRs as required.
· Leads and provides support for other Post Approval reporting to regulatory licenses, approved applications, and authorities including Annual Reports, Lot Distribution Reports, and Safety Reporting.
· Determines state and national licensing requirements for manufacturing and distribution of clinical and commercial products, submitting applications, and ensures licenses remain current.
· Reports to Principal, CMC Regulatory Policy and Strategy.
· Ph.D, Masters, or Bachelors degree in a scientific discipline with equivalent industry experience.
· Typically a minimum of 5-7 years related experience in FDA/EMA/PMDA/CFDA regulated industry with product development, manufacturing or quality experience.
· Extensive knowledge of US and international regulatory requirements and the ability to apply knowledge both strategically and operationally.
· Experience with biologics required including supporting product development, quality systems, testing, and manufacturing controls.
· Experience working with cellular or gene therapy biological products.
· Experience working with vectors used in the manufacture of cellular or gene therapy biological products.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.