Regulatory Support Specialist

Company Description

Collabera Inc (Staffing Firm). 

We are based out of Morristown, NJ and we have been providing contingent labor to our clients for last 25 years. In 2015 we placed more than 6,000 contractors across select 100+ clients that we service. End client for this project is a large legal organization with operations in more than 100 countries and has more than 50,000 employees around the world. For eight consecutive years, Fortune has named this company as World’s ‘Most Admired Companies to work for’.

Job Description

Position Details:

Location: Westborough, MA 01581

Job Title: Regulatory Support Specialist

Duration: 12+ months with a possible extension

****Please review before submitting: Candidates should not gear towards Regulatory Affairs, with most of them having a Master’s degree in RA. This position is not a typical RA position and isn’t aligned with typical RA work. The position we are interested in filling is for ‘Regulatory Support’.

An ideal candidate would have experience with bio-pharmaceutical manufacturing and be familiar with the compliance needed for components used in those processes. Alternatively, a candidate could have experience in a Bio-process consumables manufacturing company. From experience, I understand this role is unique , we are open to candidates with varying backgrounds but it is important that they have industry experiences that can help evolve independence and the high standard for quality which are critical for this role.

Description:

• Client is 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.

Qualifications

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

Additional Information

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

Ujjwal Mane

ujjwal.mane(at)collabera.com

973-805-7557