Regulatory Affairs Labeling Manager

job summary:
Advance your career with a top-tier global biopharma leader! We are seeking a Senior Manager, Regulatory Affairs for an exciting, newly created position based in Clayton, NC. This hybrid role (4 days on-site, 1 day remote) offers up to $15k in relocation support. You will join a collaborative team of six, driving worldwide regulatory product registration strategies with a dedicated focus on global labeling for life-saving biologics.

location: Clayton, North Carolina
job type: Permanent
salary: $125,000 - 140,000 per year
work hours: 9 to 5
education: Bachelors

responsibilities:

• Act as the primary Regulatory Affairs authority for key product registrations, specializing in labeling deliverables.
• Lead a focused team to facilitate global labeling changes, strategic updates, and complex submission preparations.
• Provide solutions-oriented technical regulatory guidance to executive management regarding worldwide licensure.
• Analyze worldwide product registration requirements and prepare complex dossiers for global markets.
• Collaborate cross-functionally with international affiliates, commercial teams, and regulatory authorities.

 
qualifications:



Required:

• Bachelor's degree in a scientific or relevant discipline.
• Minimum of 8 years of directly related biopharma experience (Biologics experience required).
• Minimum of 3 years of supervisory or team leadership experience.
• Proven, deep labeling expertise within biopharma (heavy medical device or exclusive regulatory operations/publishing experience will not be considered).
• Strong cross-functional communication and leadership capabilities.

Preferred:

• Advanced degree with clinical experience.
• Extensive knowledge of EU regulatory requirements and global labeling initiatives.

#LI-JW1

skills: Biologics, Labeling Compliance




Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on us.fitly.work.




Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).




This posting is open for thirty (30) days.