Regulatory Support Manager/ Regulatory Affairs Specialist/ Regulatory Affairs Associate

Collabera • Westborough, MA

1d

About The Position

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.

Requirements

• 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

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager