Job Description
job summary:
Are you a Regulatory Affairs expert with a passion for global labeling strategy?
Join a Top-Tier Global Pharma Leader in Clayton, NC, and play a pivotal role in bringing life-saving products to global markets. We are seeking a detail-oriented professional to implement worldwide regulatory product registration strategies with a specialized focus on
labeling requirements and international dossiers.
location: Clayton, North Carolina
job type: Permanent
salary: $100,000 - 125,000 per year
work hours: 9 to 5
education: Bachelors
responsibilities:
- Will focus on labeling, labeling requirements, and implementation.
- Analyze and determine worldwide product registration requirements for assigned products and regions.
- Prepare complex registration dossiers and local application forms for international markets, coordinating with Quality and Commercial teams.
- Act as the Regulatory Affairs authority for labeling-related activities, ensuring compliance with global standards.
- Coordinate with the FDA and international regulatory counterparts to obtain required export documentation and formulate registration strategies.
- Evaluate the impact of new labeling regulations on existing projects and facilitate the implementation of changes.
qualifications:
- Bachelor's degree in a relevant scientific discipline or equivalent work experience.
- Minimum 5-7 years regulatory experience within the pharmaceutical industry.
- Direct experience with biological or drug products (facilities, cGMP manufacturing, or QA/QC).
- Extensive knowledge of worldwide regulatory product registration laws and regulations.
- Excellent written and verbal communication skills for professional agency interaction.
#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 HRsupport@randstadusa.com.
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.
Job Tags
Permanent employment, Temporary work, Work experience placement, Local area, Worldwide