Associate Director, Global Labeling
1 month ago
Takeda Pharmaceuticals
Associate Director, Global Labeling
Bismarck ,
North Dakota
Apply Now
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About the role:
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.
Join Takeda as an Associate Director, Global Labeling Lead where you will be responsible for the development, maintenance, and implementation of Company Core Data Sheets (CCDS) in line with international standards and guidelines. You will provide strategic and tactical labeling expertise to teams while ensuring compliance with applicable regulatory requirements.
You will serve as the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that regulatory labeling requirements are met for assigned products.
How you will contribute:
Lead cross functional teams to develop and update CCDS and other key global labeling documents (i.e. CCDS Working Team)
In coordination with Global Labeling Oversight Committee (GLOC) Chair, manages review and approval of CCDS/resolution of labeling issues with the relevant GLOC
Evaluate risks associated with CCDS content and implementation strategies, develop mitigation plans, and appropriately escalate issues to Global Labeling management and the Global Regulatory Lead
Recommend strategies and labeling language for inclusion in key product labels (US PI, EU SmPC, JPI, others as appropriate), consistent with the overall product strategy and information in the CCDS, when available.
Provide information to Global Labeling Compliance, as required, to support internal and external (i.e. Regulatory Authority) requirements and support audits/inspections as a labeling subject matter expert
Liaise with US Labeling Operations and EU Labeling Operations to ensure labeling objectives and timelines are met
Analyze relevant competitor labeling to ensure Takeda products have competitive labeling possible; maintain awareness of recent in-class approvals.
Remain current with global standards, initiative by regulatory authorities related to the CCDS and labeling, and assure that Takeda processes conform to regulatory requirements. Propose actions as needed.
Prepare/lead training and information sessions with GRA and other functional areas to increase understanding and compliance with internal and external labeling expectations and optimal labeling strategies.
Establish cross-functional relationships to ensure control and continuous improvement of global labeling programs to meet business needs and regulatory requirements.
Minimum Requirements/Qualifications:
BSc Degree, preferred. BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred;
8+ years of pharmaceutical industry experience. This is inclusive of 6 years of labeling experience or combination of 5+ years regulatory and/or related experience.
Understanding of scientific principles and regulatory/quality systems relevant to drug development.
Knowledge of global standards and regulations related to CCDS and Product Labeling (US PI and EU SmPC experience required, other regional labels also preferred).
Demonstrates problem-solving ability to analyze risk and make appropriate recommendations/decisions.
Acceptable and independent skills in the area of regulatory affairs such as understanding broad concepts within labeling and implications across the organization and globally; proactively identify issues; offers creative solutions and strategies, including risk mitigation strategies.
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 "remote" in accordance with Takeda's Hybrid and Remote Work policy.
EEO Statement
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.
#J-18808-Ljbffr
-
Bismarck, United States Marriott Full timeMarriott Global Luxury Account Manager, Bulgari, West Coast Bismarck , North Dakota Apply Now Location Western Regional Office, 17872 Gillette Avenue Suite 300, Irvine, California, United States Schedule Full-Time Located Remotely? Y Relocation? N Position Type Management JOB SUMMARY The Global Luxury Account Manager is a luxury specialist responsible for...
-
Associate Director, Business Process
3 weeks ago
Bismarck, United States Trustmark Full timeTrustmark Associate Director, Business Process Bismarck , North Dakota Apply Now Trustmark’s mission is to improve wellbeing – for everyone. It is a mission grounded in a belief in equality and born from our caring culture. It is a culture we can only realize by building trust. Trust established by ensuring associates feel respected, valued and heard. At...
-
Bench Director of Finance
2 weeks ago
Bismarck, United States Marriott Full timeMarriott Bench Director of Finance Bismarck , North Dakota Apply Now Location Western Regional Office, 17872 Gillette Avenue Suite 300, Irvine, California, United States Schedule Full-Time Located Remotely? Y Relocation? N Position Type Management JOB SUMMARY The Bench Director of Finance is a key member of Americas Finance. This position Provide leadership...
-
Director of Operations Excellence
1 month ago
Bismarck, United States HomeSafe Alliance Full timeHomeSafe Alliance Director of Operations Excellence Bismarck , North Dakota Apply Now HomeSafe Alliance is the single global household goods movement manager of over 300,000 Military Household Goods moves per year for USTRANSCOM and the U.S. Armed Forces, Department of Defense civilians, U.S. Coast Guard, and their families. Director of Operations Excellence...
-
Director of Operations Excellence
3 weeks ago
Bismarck, United States HomeSafe Alliance Full timeHomeSafe Alliance Director of Operations Excellence Bismarck , North Dakota Apply Now HomeSafe Alliance is the single global household goods movement manager of over 300,000 Military Household Goods moves per year for USTRANSCOM and the U.S. Armed Forces, Department of Defense civilians, U.S. Coast Guard, and their families. Director of Operations Excellence...
-
Director of Sales
1 month ago
Bismarck, United States Bismarck Radisson Hotel Full timeJob DescriptionJob DescriptionThe Director of Sales (DOS) will be responsible for maximizing sales opportunities and profitability for the hotel and event center by selling and booking hotel rooms and event space. They will share responsibility for overseeing, prospecting, qualifying and maintaining new and existing accounts in the corporate, corporate group...
-
Director of Sales
3 weeks ago
Bismarck, United States Bismarck Radisson Hotel Full timeJob DescriptionJob DescriptionThe Director of Sales (DOS) will be responsible for maximizing sales opportunities and profitability for the hotel and event center by selling and booking hotel rooms and event space. They will share responsibility for overseeing, prospecting, qualifying and maintaining new and existing accounts in the corporate, corporate group...
-
Retail Associate
3 weeks ago
Bismarck, United States Eli and Co Full timeOur partners are currently seeking a dedicated and enthusiastic Retail Associate to join their team. The ideal candidate will have a strong passion for retail, exceptional communication skills, and a proactive attitude towards achieving sales targets. As a key member of their retail team, the Associate will play a crucial role in driving sales, building...
-
Bakery Associate
2 weeks ago
Bismarck, United States SpartanNash Full timeAt SpartanNash, we deliver the ingredients for a better life through customer-focused innovation. We do this for our supply chain customers and U.S. military commissaries, retail store guests and, most importantly, our Associates. In fact, we see a day when each will say, "I can't live without them."Our SpartanNash family of Associates is 17,000 strong,...
-
Retail Associate
1 month ago
Bismarck, United States The Now Full timeJob DescriptionJob DescriptionOur partners are currently seeking a dedicated and enthusiastic Retail Associate to join their team. The ideal candidate will have a strong passion for retail, exceptional communication skills, and a proactive attitude towards achieving sales targets.As a key member of their retail team, the Associate will play a crucial role in...
-
Deli Associate
3 weeks ago
Bismarck, United States SpartanNash Full timeJob Description: Position Summary:This role is responsible to work independently to prepare food, fry, package, display, and stock deli products; to ensure that you contribute to the financial best interest of the store. Additionally, this role is responsible for meeting company guidelines for guest experience, as well as complying with company guidelines...
-
Deli Associate
1 month ago
Bismarck, United States SpartanNash Full timeJob Description: Position Summary:This role is responsible to work independently to prepare food, fry, package, display, and stock deli products; to ensure that you contribute to the financial best interest of the store. Additionally, this role is responsible for meeting company guidelines for guest experience, as well as complying with company guidelines...
-
Senior Director IT Application Development
3 days ago
Bismarck, United States Marriott Full timeMarriott Senior Director IT Application Development Bismarck , North Dakota Apply Now Schedule Full-Time Located Remotely? Y Relocation? N Position Type Management JOB SUMMARY: Strategic technology leader responsible for implementing, managing, supporting, and optimizing applications and technology footprint that support owner & franchise functions. This...
-
Deli Associate
10 hours ago
Bismarck, United States SpartanNash Full timeAt SpartanNash, we deliver the ingredients for a better life through customer-focused innovation. We do this for our supply chain customers and U.S. military commissaries, retail store guests and, most importantly, our Associates. In fact, we see a day when each will say, "I can't live without them." Our SpartanNash family of Associates is 17,000 strong,...
-
Deli Associate
3 weeks ago
Bismarck, United States Family Fare Full timeAt SpartanNash, we deliver the ingredients for a better life through customer-focused innovation. We do this for our supply chain customers and U.S. military commissaries, retail store guests and, most importantly, our Associates. In fact, we see a day when each will say, "I can't live without them." Our SpartanNash family of Associates is 17,000 strong,...
-
Bakery Associate
2 weeks ago
Bismarck, United States SpartanNash Full timeAt SpartanNash, we deliver the ingredients for a better life through customer-focused innovation. We do this for our supply chain customers and U.S. military commissaries, retail store guests and, most importantly, our Associates. In fact, we see a day when each will say, "I can't live without them." Our SpartanNash family of Associates is 17,000 strong,...
-
Deli Associate
2 days ago
Bismarck, United States Family Fare Full timeAt SpartanNash, we deliver the ingredients for a better life through customer-focused innovation. We do this for our supply chain customers and U.S. military commissaries, retail store guests and, most importantly, our Associates. In fact, we see a day when each will say, "I can't live without them." Our SpartanNash family of Associates is 17,000 strong,...
-
Director Operations
2 weeks ago
Bismarck, United States Fairfield Bismarck North Full timeJob Summary: In partnership with the General Manager the Director Operations manages the overall operation of the hotel through maintaining established cost and quality standards maximizing profits developing and retaining employees and exceeding guest expectations. Examines analyzes and evaluates operations of assigned hotels to ensure adherence to company...
-
Assistant Store Director
3 weeks ago
Bismarck, North Dakota, United States SpartanNash Company Full timeAt SpartanNash, we deliver the ingredients for a better life through customer-focused innovation. We do this for our supply chain customers and U.S. military commissaries, retail store guests and, most importantly, our Associates. In fact, we see a day when each will say, "I can't live without them."Our SpartanNash family of Associates is 17,500 strong,...
-
Assistant Store Director
4 weeks ago
Bismarck, North Dakota, United States SpartanNash Company Full timeAt SpartanNash, we deliver the ingredients for a better life through customer-focused innovation. We do this for our supply chain customers and U.S. military commissaries, retail store guests and, most importantly, our Associates. In fact, we see a day when each will say, "I can't live without them."Our SpartanNash family of Associates is 17,500 strong,...
