Billerica, Massachusetts, United States · Hybrid
$182k–$273k/yr
Work Location: Billerica, Massachusetts Shift: No Department: HC-RD-RRF Regulatory Affairs for Advertising Promotion Recruiter: Molly Scheu Role-Level: 4 This information is for internals only. Please do not share outsid…
Skills: Regulatory Labeling, CCDS Development, USPI, EU SmPC, Regulatory Affairs
Lyon, Auvergne-Rhône-Alpes, France · On-site
Votre rôle : Au sein de notre entreprise, vous rejoignez la Direction des Affaires Médicales et le Pôle Stratégique en tant que référent médical national pour nos produits liés aux maladies rares. Au quotidien, vous défi…
Skills: Medical Strategy, KOL Management, Scientific Communication, Pharmacovigilance, Cross-functional Leadership
Darmstadt, Hesse, Germany · Hybrid
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives …
Skills: Management Consulting, People Advisory, Organization Management, Change Management, HR Strategy
Bangalore, Karnataka, India · On-site
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives …
Skills: Batch Operations, PLC, SCADA, Troubleshooting, Data Management
Montbonnot-Saint-Martin, Auvergne-Rhône-Alpes, France · On-site
Exprimez votre talent avec nous ! Vous voulez explorer, franchir des obstacles, faire des découvertes ? Nous savons que vos projets sont ambitieux. Les nôtres aussi ! Dans le monde entier, nos collègues ont la passion de…
Skills: Project Management, Industrialization, Risk Management, 8D Methodology, Root Cause Analysis
Bangalore, Karnataka, India · On-site
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives …
Skills: cGMP, Reagent Preparation, Organic Chemistry, Inorganic Chemistry, Aseptic Handling
Lima, Lima, Peru · On-site
Aplica tu Magia con nosotros ¿Estás listo para explorar, romper barreras y descubrir mucho más? Sabemos que tienes grandes planes. Nosotros, también, innovar con la ciencia y la tecnología para enriquecer la vida de las …
Skills: HPLC Technical Support, Water Purification Systems, Analytical Instrumentation, Preventive Maintenance, Technical Diagnostics
Darmstadt, Hesse, Germany · On-site
Your Role: As a Communications Director in our corporate press office, you will act as a senior spokesperson for the organization, and help increase our visibility as a global leader in science and technology. You will d…
Skills: Media Relations, Financial Communications, Crisis Communications, Public Relations, Strategic Communications
Jaffrey, New Hampshire, United States · On-site
$20/hr–$31/hr
Work Location: Jaffrey, New Hampshire Shift: No Department: LS-SC-UJEEG Production DSP Pleating C Shift Hiring Manager: Charles Morris This information is for internals only. Please do not share outside of the organizati…
Skills: Quality Control Inspection, GMP Standards, Standard Operating Procedures, Material Control, Machine Set Up
Sheboygan Falls, Wisconsin, United States · On-site
$20/hr–$31/hr
Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with…
Skills: Chemical Handling, Precision Weighing, Good Documentation Practice (GDP), Automated Dispensing Equipment, 6S Standards
Sheboygan Falls, Wisconsin, United States · On-site
$20/hr–$31/hr
Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with…
Skills: Chemical Handling, Automated Dispensing Equipment, Good Documentation Practice, Forklift Operation, Metric System
Taipei, Taiwan · On-site
Your role: You want to develop AI solutions that have a tangible impact on our Electronics business? Join our international team of digital experts as a Data Scientist! In this role, you will work on transformative use c…
Skills: Python, Machine Learning, Time Series Forecasting, Simulation & Optimization, Generative AI
Darmstadt, Hesse, Germany · On-site
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives …
Skills: M&A, Venture Capital, Corporate Law, Due Diligence, Contract Negotiation
Burlington, Massachusetts, United States · On-site
$137k–$206k/yr
Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with…
Skills: Business Operations, Global Project Management, Customer Experience Governance, Strategic Business Acumen, CSAT
Bangalore, Karnataka, India · On-site
Your Role: The Team Lead will manage and oversee the entire tariff classification and product screening process for the team. This role provides leadership on all HTS classification activities, ensures compliance with do…
Skills: Tariff Classification, Product Screening, Trade Compliance, HTS Classification, People Management
Jaffrey, New Hampshire, United States · On-site
$17/hr–$27/hr
Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with…
Skills: Preventive Maintenance, Breakdown Maintenance, Electro-mechanical Troubleshooting, Pneumatics, Hydraulics
Darmstadt, Hesse, Germany · On-site
Your Role Sustainability and product stewardship assessments are rapidly becoming a defining capability for science and technology companies — shaped by evolving regulations, integrated data ecosystems, and the growing d…
Skills: Python, SQL, AWS S3, System Integration, API Development
Wuxi, Jiangsu, China · On-site
Your role： Optimize inventory structure according to annual business strategy and target to keep the balance between demand and supply, including slow moving inventory reduction.Continuously improvement of the informatio…
Skills: Inventory Management, Demand Planning, Material Planning, Supply Chain Optimization, Project Management
Sheboygan Falls, Wisconsin, United States · On-site
$89k–$155k/yr
Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with…
Skills: Maintenance Management, Personnel Performance Evaluation, Budget Management, Process Safety Management, Inventory Management
Lima, Lima, Peru · On-site
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives …
Skills: SAP, Microsoft Excel, Power BI, Data Analysis, Inventory Management
Billerica, Massachusetts, United States • Hybrid
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Lead the strategic development and implementation of global labeling documents including CCDS, USPI, and EU SmPC. Provide operational leadership to cross-functional teams and manage interactions with the Labeling Decision Board.
Requires a bachelor's degree in science or health with over 8 years of pharmaceutical experience, including 5+ years in Regulatory Affairs Labeling. Must have deep knowledge of US/EU labeling requirements and experience managing teams.
Work Location: Billerica, Massachusetts
Shift: No
Department: HC-RD-RRF Regulatory Affairs for Advertising Promotion
Recruiter: Molly Scheu
Role-Level: 4
This information is for internals only. Please do not share outside of the organization.
SpringWorks Therapeutics, a healthcare company of Merck KGaA, Darmstadt, Germany, is a commercial-stage biopharmaceutical company dedicated to improving the lives of patients with rare tumors.
We developed and are commercializing the first and only FDA and EC approved medicine for adults with desmoid tumors and the first and only FDA and EC approved medicine for both adults and children with neurofibromatosis type 1 associated plexiform neurofibromas (NF1-PN).
At SpringWorks, we are committed to finding answers people with rare tumors need. We thrive in an atmosphere of passion and tenacity, fueled by the excitement of the possibilities science may unlock and driven to work with urgency because of the importance of our work. We value authenticity because diverse backgrounds, cultures, styles and abilities can only help us find the answers that people with rare tumors are looking for.
The Director of Global Labeling (Director of GL) provides strategic regulatory labeling expertise and operational leadership to cross functional teams, ensuring the successful development of company core data sheets (CCDS), regional labeling (US Prescribing Information [USPI] and EU Summary of Product Characteristics [SmPC]) and target product labels, in line with target product profiles and overall program goals. In some instances, the Director of GL may also take on the role of Team Lead for a therapeutic area (TA), overseeing Labeling Project Leads (LPLs) working on products within that TA and fostering strong collaborations with TA leadership. Additionally, the Director of GL assists the Head of Labeling and Advertising and Promotion in preparing for and facilitating interactions with the Labeling Decision Board (LDB), and also driving forward global labeling initiatives.
This role will be required to work onsite 3 days a week (Tuesday - Thursday) or more depending on business needs. #LI-Hybrid
Key Accountabilities:
Minimum Qualifications:
The expected salary range for this position is $182,100 - 273,100. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
We are Merck KGaA, Darmstadt, Germany and its global affiliates. We are a leading global science and technology company headquartered in Germany. We are curious explorers, courageous pioneers, and ingenious inventors. Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Life Science, Healthcare, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and the planet. We believe in the positive power of science and technology. It has determined our actions since 1668 and inspires us to continue researching for a future worth living. As a family-owned company with over 350 years of experience, we stand for sustainability, responsibility, and innovative strength. We take pride in being a diverse and inclusive company that values and fosters the talents and abilities of our employees. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. Privacy Statement: https://www.emdgroup.com/en/privacy-statement.html
Offices: Frankfurter Str. 250, Darmstadt, 64293, DE · 290 Concord Rd., Billerica, Massachusetts 64293, US · One Technology Place, Rockland, Massachusetts 02370, US
We are Merck KGaA, Darmstadt, Germany and its global affiliates. We are a leading global science and technology company headquartered in Germany. We are curious explorers, courageous pioneers, and ingenious inventors. Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Life Science, Healthcare, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and the planet. We believe in the positive power of science and technology. It has determined our actions since 1668 and inspires us to continue researching for a future worth living. As a family-owned company with over 350 years of experience, we stand for sustainability, responsibility, and innovative strength. We take pride in being a diverse and inclusive company that values and fosters the talents and abilities of our employees. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. Privacy Statement: https://www.emdgroup.com/en/privacy-statement.html
Offices: Frankfurter Str. 250, Darmstadt, 64293, DE · 290 Concord Rd., Billerica, Massachusetts 64293, US · One Technology Place, Rockland, Massachusetts 02370, US
