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Mgr Regulatory Labeling in Bernards, NJ at DSI

Date Posted: 3/13/2019

Job Snapshot

Job Description

About Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.
Job Summary (Describe the purpose of the job in 1-2 sentences) The Manager, Regulatory Labeling position will provide Regulatory support for labeling projects. Under the direction of the Head, Regulatory Affairs Labeling, the manager will, review and revise labeling for FDA submission, create and modify Structured Product Labeling for FDA submission, complete electronic drug listing, track and archive affiliate labeling for global products and review proposed labeling from affiliates. The Manager, Regulatory Labeling will be responsible to update the CCDS for assigned products, and manage the review of country labeling deviations and deferrals.
Responsibilities
1. Preparation of updated Core Data Sheets, and EU and US Documentation: Manages, prepares and implements regulatory documents (e.g., USPI, annotated labeling, medication guides, EU SmPC, PIL, CCDS). Facilitates cross functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Acts as point of contact for cross-functional teams on RA labeling issues. Prepares high quality labeling documents for submission to Health Authorities.
2. Ensure Compliance with Core Data Sheets/Label Changes: Manages the review of country labeling deviations from CCDS and deferral requests. Collaborates with the a cross-functional label review teams to ensure responses to Health Authority queries and requests align with the labeling.
3. Conduct Label Review Committee Meetings: Prepares labeling documents and facilitates labeling review by cross-functional teams, including the Label Working Team and the Labeling Review Committee. Builds cross-functional and cross-regional relationships. Ensures consensus and captures decisions.
4. Conduct Labeling Compliance Activities: Conduct quality reviews of labeling for submission to FDA/EMA and of CCDS. Follow processes for tracking compliance and implementation of US labeling and CCDS.
Qualifications: (What are the minimum requirements for the position?)
Education: Bachelor’s Degree required, Life Sciences major preferred.
Experience: 5+ years in the biopharmaceutical industry is strongly preferred and 2+ years of labeling experience.
Working knowledge of laws, regulations and guidelines, with Regulatory experience preferred.

Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.