Global Labeling Director - Regulatory Affairs (Hybrid)

EMD Serono, Inc.; Billerica (MA); Hybrid; USD 182,100 - 273,100; Full time

Job summary

EMD Serono, Inc. is seeking a Director of Global Labeling to provide strategic regulatory expertise for drug labeling. This role involves overseeing the development and approval of labeling documents while ensuring compliance with global standards. Candidates should have over 8 years of pharmaceutical experience and a relevant Bachelor's or Advanced degree.

The position offers a hybrid work model, requiring onsite presence 3 days a week in Billerica, MA. A strong track record in regulatory affairs and excellent communication skills are essential for success in this role.

Qualifications

• 8+ years of relevant pharmaceutical industry experience.
• 5+ years of relevant Regulatory Affairs Labeling experience.
• Meticulous in reviewing regulatory documents.

Responsibilities

• Lead development and approval of regulatory labeling documents.
• Ensure labeling accuracy for healthcare professionals and patients.
• Maintain expertise on key labeling requirements worldwide.

Skills

Labeling requirements knowledge (US/EU)

Regulatory Affairs experience

Communication skills

Education

Bachelor’s degree in science or health-related discipline

Advanced degree (PhD, MD, MS, PharmD, MBA)

Tools

MS Office Suite

SharePoint

regulatory systems (e.g., EDMS)

Job description

EMD Serono, Inc. is seeking a Director of Global Labeling to provide strategic regulatory expertise for drug labeling. This role involves overseeing the development and approval of labeling documents while ensuring compliance with global standards. Candidates should have over 8 years of pharmaceutical experience and a relevant Bachelor's or Advanced degree.

The position offers a hybrid work model, requiring onsite presence 3 days a week in Billerica, MA. A strong track record in regulatory affairs and excellent communication skills are essential for success in this role.