Job Title: Regulatory Support Manager
Duration: 12 months with a possible extension
• The temporary Regulatory Support Manager will have responsibility for providing support to Product Managers, Regions and Customers by providing quality documents and regulatory support in response to customers’ 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 in addition to customers’ regulatory requirements related to the BioProcess business at a high level.
• Respond efficiently and promptly to customers’ regulatory based issues, which will include necessary investigations, generation and delivery of statements, and use of available internal and external databases.
• Specify, prepare, update and review regulatory support documentation, statements, certificates and other regulatory related documentation for existing single-use products.
• Bachelors degree in Chemistry, Pharmacy or related field
• Experience in quality assurance, regulatory, product management or a related field from the pharmaceutical or biotech area
• Understanding of GMP and knowledge of regulatory requirements in the bioprocess industry
• High standard for quality and ability to work independently
• Organized, target and customer oriented
To know more about this position, please contact:
Himanshu Prajapat
973-606-3290
himanshu.prajapat(at)collabera.com
Job details are sourced from the employer's original posting.
Open job postingAbout the company
We provide cost-effective, high quality IT resources to meet talent needs through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs. Collabera has been a leader in IT staffing for over 24 years and is one of the largest diversity IT staffing firms in the industry. We are known for our high-touch, customer-centric approach, offering our clients unmatched quality, responsiveness and flexibility. We are appreciated by our clients for our streamlined execution, highly efficient service and exceptional talent management that go above and beyond traditional staffing services. Collabera has been named the Best Staffing Firm to Work For in the large firm category by Staffing Industry Analysts, the global advisor on contingent work, for four consecutive years.