Takeda Pharmaceuticals Sr. Manager, Global Labeling (REMOTE) 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.
TAK-279 is a potential best-in-class, oral allosteric tyrosine kinase 2 (TYK2) inhibitor currently in development for the treatment of psoriasis and psoriatic arthritis. Takeda will evaluate TAK-279 in additional immune-mediated diseases including systemic lupus erythematosus (SLE) and Inflammatory Bowel Disease (IBD).
Join Takeda as a Sr Manager., Global Labeling (Remote)
How you will contribute:
Leads 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.
Authors/manages outgoing communications regarding significant labeling changes and CCDS changes for assigned products.
Evaluates risks associated with CCDS content and implementation strategies, develop mitigation plans, and appropriately escalate issues to Global Labeling management and the Global Regulatory Lead.
Recommends 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.
Provides labeling strategy and guidance to Local Operating Company (LOC) Regulatory, in collaboration with the RA Sub team.
Provides 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.
Liaises with US Labeling Operations and EU Labeling Operations to ensure labeling objectives and timelines are met.
Remains current with global standards and, initiatives by regulatory authorities related to the CCDS and labeling, and assures that Takeda processes conform to regulatory requirements. Propose actions as needed.
Identifies and leads initiatives, as requested, to enhance Global Labeling processes and systems. Participates in training LOC regulations on relevant labeling policies and procedures, as needed. Prepares training materials as required.
BSc Degree is preferred. BA accepted.
6+ years of pharmaceutical industry experience. This is inclusive of 5 years of labeling experience a combination of 6+ years of 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).
Strong oral and written communication, managing and adhering to timelines, negotiation skills, integrity, and adaptability.
Demonstrates problem-solving ability with the ability to analyze risk and make appropriate recommendations/decisions.
Must work well with others and within global teams.
Acceptable and independent skills in regulatory affairs such as understanding broad concepts within labeling and implications across the organization and globally; proactively identifying issues; offering creativesolutions 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 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: $130,000 – $155,000, 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.
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.
USA - GA - Virtual