Senior Global Regulatory Labeling Specialist

Grifols; North Carolina; On-site; USD 85,000 - 115,000; Full time

Job summary

Grifols seeks a Regulatory Affairs professional in Clayton, NC to implement global registration strategies, ensuring compliance with labeling requirements for product shipments. The role involves analyzing registration needs, preparing documentation, and collaborating with various departments to manage regulatory submissions effectively.

Qualified candidates should have a Bachelor’s degree, extensive regulatory experience, and demonstrate strong communication and organizational skills. The position offers an opportunity to impact healthcare positively on an international scale.

Qualifications

• 6 to 7 years of regulatory experience in the pharmaceutical industry.
• Advanced degree with clinical experience preferred.
• Minimum of 8 years of industry experience for Senior Manager.

Responsibilities

• Act as Regulatory Affairs authority for product registrations.
• Prepare complex registration dossiers and local application forms.
• Communicate and negotiate with local market authorization holders.

Skills

Labeling submission preparation

Regulatory communication

Analytical skills

Microsoft Office proficiency

Team collaboration

Education

Bachelor’s degree in relevant discipline

Tools

Microsoft Excel

Regulatory publishing tools

Job description

Grifols seeks a Regulatory Affairs professional in Clayton, NC to implement global registration strategies, ensuring compliance with labeling requirements for product shipments. The role involves analyzing registration needs, preparing documentation, and collaborating with various departments to manage regulatory submissions effectively.

Qualified candidates should have a Bachelor’s degree, extensive regulatory experience, and demonstrate strong communication and organizational skills. The position offers an opportunity to impact healthcare positively on an international scale.