Astellas Pharma Associate Director Quality/Regulatory Affairs - CCDS Labeling Compliance in Northbrook, Illinois
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 .
In the United States of America,,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 & Scope:
Support CCDS and Labeling Organization 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 function 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
Essential Job Responsibilities:
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.
Cooperate with other relevant departments regarding the implementation of specific labeling programs and tools; ensure consistent, robust processes in line with Astellas standards.
Set up KPIs for ensuring that performance can be measured, and continuous improvements can be achieved.
This position has direct impact on the compliance and operational execution of global CCDS and Labeling RA activities.
This position will report to the head of CCDS and Labeling.
MS Degree in Pharmacy or other Life Science or equivalent by experience
At least 8- 10 years Regulatory Affairs experience or, 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
It is recognized that this role will require considerable regulatory and leadership experience, a good track record, and clear leader behaviours focused at collaboration & shared accountability
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Category Medical & Development
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans