at Takeda Pharmaceuticals in Montpelier, Vermont, United States
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
The Global Labeling Regulatory Operations role will provide tactical labeling operations expertise to teams while ensuring compliance with applicable regulatory requirements related to submission of labeling, labeling artwork development, and associated processes. Working with the Global Labeling Leads, Global Regulatory Leads, Local Regulatory Leads, Quality and Supply Chain Management you will ensure timely and accurate labeling for new product launches and product changes.
Leveraging your subject matter expertise and knowledge of US labeling requirements, you will:
+ Serve as regulatory expert for product labeling components (submission, packaging artwork and mock ups) to ensure that regulatory labeling requirements are met for assigned products
+ Maintain project timelines and collaborating with the Global Labeling Lead driving on time delivery of operational pre and post approval labeling activities
+ Manage labeling in Document Management/Quality Management/Artwork Management systems
+ Manage Regulatory Labeling Submissions files to ensure they are submission ready
+ Stay current with regulations / guidance tied to labeling and packaging artwork for impact on new product introductions and life cycle management of products already on market
+ Manage Electronic Labeling (i.e. Structured Product Labeling) with the support of external vendors
+ Coordinate with Labeling Strategy and Labeling Ops colleagues, as appropriate, to ensure seamless support of drug and drug/device combination products
+ Lead the development of artwork files including the Takeda Artwork Management system, ensuring the successful preparation, and submission availability, of packaging artwork files
+ Communicates the regulatory driven implementation guidance of packaging artwork files to Global Supply Chain to ensure timely change of packaging components for assigned products
+ Effectively communicates regulatory strategies tied to the packaging artwork and the impact of labeling changes on submission plans and timelines; as well as impact assessments of trends, regulations and changes related to labeling
+ Communicates the regulatory driven implementation guidance of packaging artwork files to Global Supply Chain to ensure timely change of packaging components
+ Be responsible for working with suppliers for translation services where required
+ Be responsible for coordinating and providing Regulatory Labeling Assessments into the quality management system for any changes impacting product labeling
+ Define, develop and execute Global Labeling Operations strategies to maximize regulatory success towards achievement of program objectives across pipeline, including drugs, devices and drug/device combination products
+ Participate in cross-functional and GRA initiatives to represent Labeling needs related to technology, systems and Regulatory Information Management to ensure the teams meet their goals and objectives
+ Partner and coordinate with vendors to ensure that Labeling KPIs are achieved; and labeling operation deliverables are completed consistently and in accordance with market regulations and Takeda’s standard operating procedures
+ Bachelor’s degree preferred, equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above. All employees must read, write and speak fluent English.
+ 6 years of directly related experience is desirable. This is inclusive of thorough regulatory experience, supply chain, Local Market or related experience in both development and /or post-marketing phases.
+ Strong operational regulatory and business experience, including knowledge of regulations and guidance governing drugs and biologics labeling in all phases of development (relevant to role)
+ Preferred expertise in packaging regulations and processes involved in the generation and review of labeling artwork/mockup
+ Knowledge of the requirements for artwork in US and/or EU (relevant to role). Experience in the preparation and submission of artwork using artwork management systems (e.g. BLUE, Webcenter) beneficial
+ Ability to proactively identify regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
What Takeda can offer you:
+ Comprehensive Healthcare: Medical, Dental, and Vision
+ Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
+ Health & Wellness programs including onsite flu shots and health screenings
+ Generous time off for vacation and the option to purchase additional vacation days
+ Community Outreach Programs and company match of charitable contributions
+ Family Planning Support
+ Flexible Work Paths
+ Tuition reimbursement
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.
Base Salary Range: $102,200- $146,000 based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Massachusetts – Virtual