Global Labeling Regulatory Affairs Manager

Grifols, S.A; Clayton (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Grifols, S.A in Clayton, NC is seeking a Manager/Sr. Manager for Regulatory Affairs focusing on labeling strategies and compliance. The role involves preparing registration dossiers, interacting with regulatory agencies, and leading regulatory submissions globally.

Ideal candidates should possess a Bachelor’s degree, relevant regulatory experience, and strong communication skills to effectively manage product registration processes.

Qualifications

• 6 to 7 years of related technical and/or regulatory experience in pharmaceutical industry.
• Ability to work independently and communicate complex regulatory requirements.
• Experience in developing drug/biologics labeling for the US market.

Responsibilities

• Lead regulatory authority for key product registrations focused on labeling.
• Prepare complex registration dossiers and negotiate documentation.
• Evaluate impact of new labeling regulatory requirements.

Skills

Regulatory submission preparation

Project management

Strong communication

Technical regulatory guidance

Microsoft Office proficiency

Education

Bachelor's degree in relevant discipline

Advanced degree with clinical experience

Job description

Grifols, S.A in Clayton, NC is seeking a Manager/Sr. Manager for Regulatory Affairs focusing on labeling strategies and compliance. The role involves preparing registration dossiers, interacting with regulatory agencies, and leading regulatory submissions globally.

Ideal candidates should possess a Bachelor’s degree, relevant regulatory experience, and strong communication skills to effectively manage product registration processes.