Regulatory Support Manager/ Regulatory Affairs Specialist/ Regulatory Affairs Associate

Company Description

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 true potential of human capital and provides people the right opportunities for growth and professional excellence.

Job Description

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.

Qualifications

• 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

Additional Information

To know more about this position, please contact:

Himanshu Prajapat

973-606-3290

himanshu.prajapat(at)collabera.com