Associate Director/Director, Regulatory Affairs Labeling in Bernards, NJ at DSI

Date Posted: 7/6/2018

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

This position serves as the RA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages multiple assigned projects of increased complexity including post marketing projects and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the development and maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the development and maintenance of global labeling and associated documents (including cartons and external packaging) for assigned Daiichi Sankyo products. This position ensures that draft labeling complies with all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. Leads Health Authority labeling preparation meetings in anticipation of final labeling negotiation and approval. Additionally, this position mentors and manages assigned staff and/or matrix teams, This position interacts across the RA function globally and interacts across functional as well as regional areas. This position often works with ambiguity and complex problems, focusing on strategic and operational decisions. This position works on complex issues and acts as a decision maker with management alignment.

Responsibilities

Preparation of new and updated Core Data Sheets, EU and US Documentation: Independently manages, prepares and implements regulatory documents (e.g., draft launch labeling, USPI, annotated labeling, medication guides, EU SmPC, PIL, CCDS). Independently leads cross functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as needed. Acts as point of contact for cross-functional teams on RA labeling issues.

Ensure Compliance with Core Data Sheets/Label Changes: Provides labeling development strategic plan and has broad oversight for Core Data Sheets/label changes. Manages US and local country labeling deviations from CCDS; reviews and approves CCDS/labeling agreements for licensing partners.

Conduct Label Review Committee Meetings: Prepares documents independently. Leads processes and associated systems to ensure appropriate review and governance of US, EU and global Company Core Data Sheet documents.

Ensure Compliance with Labeling Regulations and Guidances: Demonstrates expert knowledge of labeling guidances. Manages compliance with labeling regulations and guidelines, reviewing package inserts, cartons and labels for compliance with regulations with regard to both content and format. Ensures inserts, cartons and labels of marketed products comply with current guidelines as needed.

Establishes Process and System Best Practices: Serves as a role model and leads the use and implementation of labeling best practices. Assists in the development of Standard Operating Procedures (SOPs) and process improvements (e.g., LRC review process and automated global labeling implementation management and tracking systems) and develops optimal CCDS/labeling agreement templates for licensing partners.

Department Coordination: Builds cross-functional and cross-regional relationships.

People Management: Mentors and manages assigned staff and/or matrix teams.

Qualifications

Education and Experience
  • Bachelor’s Degree, preferably in a scientific discipline
  • Prefer an advanced degree (e.g., Masters, Pharm.D., Ph.D.)
  • 7-12 years pharmaceutical industry experience required with 3-5+ years of direct regulatory affairs experience, including US labeling experience
  • Experience with ex-US labeling a plus (outside the US)
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.