Senior Manager, Global Labeling

ManagerManagerFull TimeRemoteTeam 5,001-10,000H1B SponsorCompany Site LinkedIn

Location

United States

Posted

61 days ago

Salary

$132K - $176K / year

Bachelor Degree5 yrs expEnglish

Job Description

• Lead creation and maintenance of core, EU, and US labeling documents for approved products • Support development of labeling for pipeline products • Drive cross-functional labeling team discussions and secure senior management endorsement • Propose and align labeling strategies with regulatory objectives • Oversee distribution and tracking of Company Core Data Sheet (CDS) updates • Deliver EU Product Information (EUPI) and US Prescribing Information (USPI) in line with regulations • Oversee coordination of artwork and EMA linguistic reviews • Ensure compliance with Health Authority timelines for SPL submissions and regional implementation • Maintain labeling compliance, SOPs, and support audits • Provide training and guidance on labeling processes and standards

Job Requirements

Bachelor's degree in a scientific or medically related discipline
5+ years pharmaceutical/ biotechnology industry regulatory experience, including regulatory labeling
Strong knowledge of global labeling regulations and processes
Proficiency with EDMS and regulatory tracking systems
Experience interpreting regulatory guidelines and policies
Excellent organizational and prioritization skills
Effective cross-functional and cross-cultural collaboration
Strong written and oral communication skills

Benefits

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation