Takeda Pharmaceuticals Director, Global Labeling Operations in Helena, Montana
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 to bring life-changing therapies to patients worldwide.
Join Takeda as a Director, Global Labeling Operations where you will develop, implement, and oversee Takeda’s US and EU Labeling Operation Teams.
You will contribute internally and externally, to cross-functional initiatives and influence the field as applicable as part of the Global Regulatory Affairs team. You will report to the Head of Global Labeling Operations and Excellence.
How you will contribute:
As Director, Labeling Operations you will establish and lead the Global Labeling Operations function. This includes:
Responsible for the Labeling Operations strategy to deliver high-quality submission labeling and artwork that meets regulatory timelines and that is in compliance with US and EU (CP, MRP, and DCP) artwork guidance and implementation timelines.
Establish and lead the internal and external Labeling Operations of US and EU Teams.
Responsible for the Labeling Operations strategy to deliver high-quality labeling artwork that meets regulatory timelines and that is in compliance with US and EU (CP, MRP, and DCP) artwork guidance and implementation timelines.
Provide US and EU regulatory expertise and guidance to Global Labeling, Global Supply Chain, Legal, Global Regulatory Strategy, Commercial, and other internal stakeholders.
Provide expert advice on current US and EU labeling requirements, templates, tools, and Health Authority-issued guidance.
Provide guidance and oversight for EU labeling translations. Oversee vendor performing artwork and translations activities on behalf of Takeda:
Planning, assigning, and directing work via vendor interface
Providing performance feedback to vendor(s)
Escalating non-performance or compliance issues via the appropriate procedures and systems
Working with vendor management to ensure appropriately trained staff to support Takeda programs
Formulate regulatory labeling strategies for implementation of US/EU new and revised prescribing/patient information and packaging and timing relating to labeling revisions.
Embrace and demonstrate a diversity and inclusion mindset and role model these behaviors for the organization.
Technical/Functional (Line) expertise (breadth and depth of knowledge, application, and complexity of technical knowledge).
Strong knowledge of the business area, and regulatory environment, and ability to identify and proactively manage the interactions necessary for achieving business goals and objectives.
Demonstrated knowledge of global health authorities, regulations, product approval, labeling, and lifecycle processes for major markets and of pharmaceutical and regulatory affairs requirements and practices.
Project management abilities.
Leadership (vision, strategy and business alignment, people management, communication, influencing others, managing change).
Demonstrated ability to work across functions, regions, and cultures.
Enterprise-level leadership with the ability to inspire, motivate and drive results.
Excellent communicator, able to persuasively convey both ideas and data, verbally, and in writing.
Ability to distill complex issues and ideas down into simple comprehensible terms.
Broad decision-making responsibilities:
ability to make highly complex decisions that impact the enterprise
accountable for decision-making for the designated function
ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution
Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations).
Ability to work in a global ecosystem (internal and external) with a high degree of complexity.
The breadth of knowledge required across end-to-end labeling processes, functions, and stakeholders.
Bachelor’s degree (or equivalent) required. Masters preferred.
10+ years experience in the Pharmaceutical or Medical Device industry, with 8 years in Regulatory Affairs, labeling, or quality assurance/compliance.
Must have a detailed understanding of pharmaceutical drug development and global regulations pertaining to labeling artwork.
Excellent knowledge of EU and US labeling requirements and ability to communicate and strong operational regulatory and business experience, including knowledge of regulations and guidance governing drugs and biologics labeling in all phases of development for the US and/or EU (relevant to the 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 the US and/or EU (relevant to the 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.
Expertise in labeling artwork, supply chain, Regulatory Strategy, and commercial.
Knowledge of global guidance relevant to labeling, drug development, and commercialization of prescription medicines.
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 a company match of charitable contributions
Family Planning Support
Flexible Work Paths
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.
Base Salary Range: $156,800- $224,000, based on the candidate's 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. This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq
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