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Director, Labeling

4 months ago

Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

Join a Legacy of Innovation 110 Years and Counting

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary

This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the development and maintenance of the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines, internal company procedures and company business objectives. This position manages new projects and projects of increased complexity including those involving 3rd party collaborators The position may manage a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead.

This position leads labeling meetings for preparation of responses to comments from HAs, meeting required timelines to achieve final labeling approval. Additionally, this position mentors and may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- regional representatives on the labeling review teams as well as with business partners to achieve high quality and accurate labeling in support of business objectives.

Responsibilities

Preparation of new and updated Core Data Sheets, EU and US Documentation: As the project lead, Independently or through direction of a team of GLLs, manage, develop prepare and implement regulatory documents (e.g., draft launch labeling, USPI, annotated labeling, medication guides, EU SmPC, EU PL, CCDS, CCPL)for new products or products in the development phase. Independently lead cross functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategize and plan for FDA meetings as needed. Acts as point of contact for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other regions, including Japan, while developing the CCDS.Ensure Compliance with Core Data Sheets/Label Changes: Develop and communicate strategic labeling development strategic plan to other project team GLLs and to cross-functional labeling review team members. Responsible for the broad oversight of Core Data Sheets and US/EU label changes for products in the development phase, including across overlapping updates managed by multiple GLLs. Manage US and local country labeling deviations from CCDS; review and approve CCDS/labeling agreements for licensing partners.Conduct Label Review Committee Meetings: Independently or through oversight of a team of GLLs, prepare labeling documents for review. Lead review processes to ensure appropriate review and governance by Daiichi Sankyo, and where applicable, partner companies for the development and approval of US, EU and global CCDS documents for regulatory filings and HA labeling discussions. Collaborate with colleagues in Japan to ensure timeline review of labeling deviations by the appropriate labeling committees. Collaborate with country RA to ensure appropriate background is provided to the labeling review team members for the consideration of labeling deviation requests for Daiichi Sankyo and partner companies, if applicable.Ensure Compliance with Labeling Regulations and Guidances: Demonstrate expert knowledge of global labeling guidances. Ensure compliance with internal and external labeling guidelines, reviewing US and EU package inserts for assigned products with regard to both content and format. Ensure compliance with internal processes for record keeping and tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes Process Best Practices: Serve as a role model for less experienced members of GRA labeling, labeling review teams and partner companies, reinforcing the use and implementation of labeling best practices. Assist or lead the development of Standard Operating Procedures (SOPs) and process improvements. Conduct team meetings with direct reports or a team of GLLs to ensure alignment of labeling content and strategy and to optimize resourcesDepartment Coordination: Builds cross-functional and cross-regional relationships.People Management: Mentor, develop and managed assigned staff and/or matrix team members.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)Bachelor's Degree preferably in a scientific discipline; requiredan advanced degree (e.g., Masters, Pharm.D., Ph.D.) preferred Experience Qualifications 10 or More Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including CCDS and US/EU labeling experience requiredExperience with country labeling a plus (outside the US/EU) preferred Travel - Join a Legacy of Innovation 110 Years and Counting

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary This position serves as the GRA 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 maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) 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. 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.

ResponsibilitiesActs as point of contact for cross-functional teams on global labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (e.g., 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. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for assigned products. Manages US/EU and local country labeling deviations from CCDS; Ensures implementation of CCDS/labeling agreements with licensing partners.Conduct Label Review Committee Meetings: Prepares documents for review by labeling teams. Leads review processes and ensures appropriate governance for US, EU and Company Core documents as well as for the review of country labeling deviations.Ensure Compliance with Labeling Regulations and Guidance: Researches applicable Health Authority labeling regulations for products and filings. Manages compliance with internal and external guidelines, reviewing US and EU package inserts with regard to both content and format. Follows internal processes for record keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best practices at cross-functional meetings. Assists in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners.Department Coordination: Builds cross-functional and cross-regional relationships.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)Bachelor's Degree preferably in a scientific discipline requiredadvanced degree (e.g., Masters, Pharm.D. or Ph.D.) preferredExperience Qualifications7 or More Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experienceExperience with ex-US labeling (outside the US) preferredTravel Ability to travel up to 10% Occasional travel
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. 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.