Senior Manager, Global Regulatory Labeling Strategy

Job not on LinkedIn

September 4

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $137k - $215.3k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

Apply Now

Receive Emails with Similar Jobs

Takeda

WebsiteLinkedInAll Job Openings

Biotechnology • Pharmaceuticals • Healthcare Insurance

Takeda is a global biopharmaceutical company dedicated to bringing better health and a brighter future to patients worldwide. With a strong focus on research and development, manufacturing, and quality, Takeda operates with a commitment to ethics and a diverse workforce that spans over 80 countries. The company leverages innovative science and partnerships to create impactful medicines, including therapies in oncology and vaccines, ensuring that they effectively meet the needs of the patients they serve.

10,000+ employees

Founded 1781

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 Grant on 2016-08

📋 Description

• Leads Labeling cross-functional teams, facilitates discussions on labeling strategies and content for assigned product(s) and ensures cross-functional collaboration and alignment, with appropriate supervision and guidance. • Coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee – GLOC) and facilitates discussions to ensure cross-functional collaboration and alignment of the labeling strategy and labeling content at all levels. • Authors revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation. • Develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI and EU SmPC. • Authors/manages outgoing communications regarding significant labeling changes and CCDS changes for assigned products. • Employs project management skills to interface with global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and participates in label negotiations with Health Authorities. • Manages the process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals. • Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals. • Escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products. • Conducts precedent searches, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for assigned product labels. • Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met. • Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products. • Vendor management oversight and accountability for labeling activities managed by external vendor(s) for assigned products.

🎯 Requirements

• BSc degree preferred; BA accepted. • Advanced scientific degree (MSc, PhD, or PharmD) preferred. • 6+ years of pharmaceutical industry experience. • This is inclusive of 4 years of labeling experience or combination of 4+ years regulatory and/or related experience. • Knowledge of US and EU product labeling regulatory requirements and guidelines. • Familiarity with US and/or EU regulatory requirements and guidelines. • Familiarity with other relevant regional regulatory nuances and requirements. • Basic knowledge of scientific principles and regulatory/quality systems relevant to drug development. • Ability to co-author, revise and/or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions with appropriate supervision and guidance. • Ability to identify factors and requirements necessary for regulatory recommendations. • Ability to develop regulatory strategies based on regulatory requirements and competitive landscape.

🏖️ Benefits

• U.S. based employees may be eligible for short-term and/or long-term incentives. • U.S. based employees may be eligible to participate in medical, dental, vision insurance. • 401(k) plan and company match. • Short-term and long-term disability coverage. • Basic life insurance. • Tuition reimbursement program. • Paid volunteer time off. • Company holidays. • Well-being benefits. • Up to 80 hours of sick time per calendar year for U.S. based employees. • New hires are eligible to accrue up to 120 hours of paid vacation.