Regulatory Support Specialist

Description:

• We are looking for a Regulatory Support Specialist for its single-use area.

• These single-use products are used by customers in biopharmaceutical manufacturing.

• The temporary role will provide support to Product Managers, Regions and Customers of single use products 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.

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

• Strong written and verbal communication skills -Flexible and service-minded with the ability to be collaborative

If you are interested and want to apply, Please contact:

Ujjwal Mane

973-805-7557

ujjwal.mane(at)collabera.com