Regulatory Support Manager/Regulatory Affairs Specialist/Regulatory Affairs Associate
Listed on 2025-12-01
-
Quality Assurance - QA/QC
- Contract
Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs.
Collabera recognizes the true potential of human capital and provides people the right opportunities for growth and professional excellence.
Job Title:
Regulatory Support Manager
Duration: 12 months with a possible extension
The temporary Regulatory Support Manager will be responsible for providing support to Product Managers, Regions, and Customers by delivering quality documents and regulatory support in response to customer requests for quality, regulatory, and technical-related information.
As a member of the Customer Regulatory Support team, you will add value to biopharmaceutical customers’ single-use products while demonstrating a commitment to customer satisfaction.
Essential Responsibilities:
- Build knowledge and understanding of Single-Use products and the regulatory requirements related to the Bio Process business.
- Respond efficiently and promptly to customers’ regulatory issues, including investigations, generation, and delivery of statements, utilizing internal and external databases.
- Specify, prepare, update, and review regulatory support documentation, statements, certificates, and other regulatory-related documents for existing single-use products.
Minimum Qualifications:
- Bachelor's degree in Chemistry, Pharmacy, or a related field.
- Experience in quality assurance, regulatory affairs, product management, or a related field within the pharmaceutical or biotech industry.
- Understanding of GMP and regulatory requirements in the bioprocess industry.
- High standards for quality and the ability to work independently.
- Organized, target-oriented, and customer-focused.
To know more about this position, please contact:
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