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 to 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 remote and is based in Bangalore India 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 Guidelines 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 effective use of all global labeling systems effective support of inspections and audits Requirements 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 behaviors 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 Astellas Global Capability Centres - Overview Astellas Global Capability Centres GCCs are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed Our three GCCs are located in India Poland and Mexico The GCCs will enhance our operational efficiency resilience and innovation potential enabling a timely response to changing business demands Beware of recruitment scams impersonating Astellas recruiters or representatives Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address If you encounter a fake profile or anything suspicious report it promptly to LinkedIn s support team through LinkedIn Help Our GCCs are an integral part of Astellas guided by our shared values and behaviors and are critical enablers of the company s strategic priorities sustainable growth and commitment to turn innovative science into VALUE for patients