Director CCDS Labeling Strategy
Astellas

Job Info

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Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

The Director CCDS Labeling Strategy Lead will report to the Executive Director, CCDS and Labeling, and sit on the labeling leadership team. In collaboration with strategic regulatory, this position will be responsible for regulatory leadership and support (both technical and operational) in the area of CCDS (Company Core Data Sheets) and product labeling for key market products in all primary focus areas. This will include new products and life cycle management of existing portfolio. This position will function as a CCDS Labeling Lead for a key market product and will be responsible for all aspects of CCDS labeling development including creating, updating, and maintaining labeling content documents throughout the product lifecycle. This position will help maintain controlled records for historical, current and ending labeling changes. This position will manage labeling content review and approval process applying regulatory, therapeutic area and clinical knowledge to the process.

This position will have the responsibility of the CCDS Labeling Lead, providing oversight to other Regulatory personnel including CCDS Labeling Leads (CLL) who are responsible for developing or managing CCDS and labeling content and ensuring consistency across product labels. As needed, this position will also help to implement process improvement changes to increase the efficiency and effectiveness of the label review process.

Essential Job Responsibilities:

Key responsibilities include development of target product labels, CCDS and label development and supporting the development of key major markets Labeling across Astellas products. This position will also be responsible for ensuring quality documentation processes and QC of all labeling documents.

This position will function as a CCDS Labeling Lead for products in all primary focus areas and will be responsible for all aspects of labeling development including creating, updating, and maintaining labeling content documents throughout the product lifecycle. This position will help maintain controlled records for historical, current and ending labeling changes. This position will manage labeling content review and approval process applying regulatory, therapeutic area and clinical knowledge to the process.

This position will also act as the Key Market Labeling Lead providing oversight to other Regulatory personnel including CCDS Labeling Leads (CLLs) who are responsible for developing or managing labeling content and ensure consistency across product labels. As needed, this position will also help to implement process improvement changes to increase the efficiency and effectiveness of the label review process. This position will be responsible for leading the creation, implementation and maintenance of the CCDS applying scientific and clinical knowledge to the process. The position will understand and incorporate all key labeling guidance's, FDA, Health Canada, Pharmaceutical and Medical Device Agency (PMDA), National Medical Products Administration (NMPA) and EU guidance's into labeling strategies for those regions.

This position will be able to liaise with key regulators, FDA, Health Canada, PMDA, NMPA, and EMA for formal written and verbal negotiations. This position will participate in identification of risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans. This position will assess impact of new labeling regulations and implement appropriate changes as well as lead development of company policy and position on draft regulations and guidance. This position will interact cross-functionally with members of RA, asset team, commercial, legal, safety, medical and others.

Quantitative Dimensions:

This position will have direct impact on the development and changes of CCDS and labeling, management/coordination of regional strategies of local labeling regarding implementation of CCDS updates, and labeling compliance for all Astellas marketed products in the key market regions. This position will have impact on the successful registration of new products, indications, and line extensions.

Organizational Context:

This position will independently interface and effect decisions with local and global team members (e.g., Pharmacovigilance, Medical Affairs, and affiliates members). The position reports to the Executive Director, CCDS and Labeling, Regulatory Affairs. The individual may have direct reports at the Associate Director and Manager levels.

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