Regulatory Support Manager/ Regulatory Affairs Specialist/ Regulatory Affairs Associate

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