Lead, RA CCDS & Labeling Compliance

Purpose and Scope:

• Support CCDS and Labeling Operations by providing compliance and operational oversight of the CCDS process, the Global Labeling process and support to inspections and audits.
• For the operational aspect of the role, the focus is to monitor and manage change control metrics for labeling, with attention to safety changes. Additionally, overall monitoring of labeling operations activities within internal systems (e.g., EAGLE).
• Support the global RA Labeling/CCDS activities with the end goal to ensure efficient, timely, high-quality labeling submissions compliance with all applicable guidelines and procedures efficient use of all global labeling systems effective support of inspections and audits.

Responsibilities and Accountabilities:

• Support oversight of agreed upon labeling submissions and approvals globally.
• Support countries to ensure compliance at the local level with global labeling procedures.
• Ensure that the internal systems (e.g., CCTA and EAGLE) are populated in line with the Astellas policies and

procedures.

• Support quality compliance of marketed products, in line with internal and local regulatory policies, as well as

securing timely labeling submissions.

• Participate in the review and development of RA labeling tools and systems and provide training accordingly.
• Support GxP audits and inspections related to global CCDS and labeling.
• Participate in the review and development of RA labeling practices and policies and provide training

accordingly.

• Ensure compliance of regulatory labelling practices with the relevant SOPs through a quality self-inspection

and audit system.

• Ensure process efficiency, optimization and technical alignment globally for labeling.
• Coordinate training activities to ensure skill development and compliance with global labeling procedures.
• Contribute to a seamless relationship and teamwork for RA globally in order to establish best practices and quality processes for CCDS and Labeling.

Required Qualifications:

• Master’s degree in Pharmacy or other Life Science or equivalent by experience
• At least 8 years Regulatory Affairs experience, including working within a global environment
• Experience with managing projects and working within a matrixed organization
• Knowledge of Regulatory landscape, systems and procedures for CCDS and Labeling
• Proficiency in English language
• Excellent communication, influential, planning and problem-solving skills, along with the ability to build and

manage close relationships with all relevant stakeholders

• Proven affinity and capability to work within teams where there is no direct reporting relationship

Preferred Qualifications:

It is recognized that this role will require considerable regulatory and leadership experience, a good track record,

and clear leader behaviours focused on collaboration & shared accountability.

Working Environment

• At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working

solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We

believe this will optimize the most productive work environment for all employees to succeed and deliver.

Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility