Global Regulatory Labeling Lead — Middle East & APAC

Moderna; Województwo mazowieckie; On-site; PLN 363,000 - 509,000; Full time

Job summary

A leading biotechnology company in Warsaw is seeking a Senior Manager, Global Regulatory Labeling Operations to lead compliance and submission of product labeling worldwide. The ideal candidate will have extensive experience in regulatory affairs and labeling, contributing to impactful projects in mRNA technology. This role is pivotal for ensuring global product access and requires strong leadership and analytical skills.

Benefits

Quality healthcare and insurance benefits

Generous paid time off

Lifestyle Spending Accounts

Free premium access to fitness classes

Qualifications

• 5-8 years of experience in the pharmaceutical industry, preferably 5+ years in Regulatory Affairs.
• Experience facilitating meetings and driving consensus.
• Proven ability in medical/technical writing.

Responsibilities

• Ensure compliance across labeling deliverables.
• Manage submission of labeling components to health authorities.
• Oversee the end-to-end labeling lifecycle.

Skills

Regulatory Affairs knowledge

Labeling experience

Leadership skills

Communication skills

Analytical thinking

Education

Bachelor’s degree

Advanced degree

Job description

A leading biotechnology company in Warsaw is seeking a Senior Manager, Global Regulatory Labeling Operations to lead compliance and submission of product labeling worldwide. The ideal candidate will have extensive experience in regulatory affairs and labeling, contributing to impactful projects in mRNA technology. This role is pivotal for ensuring global product access and requires strong leadership and analytical skills.