Job Description

Job Description

Job Title: Senior Regulatory Affairs Specialist – Biotechnology

On site Mon thru Fri located in Totowa NJ

Overview

The individual will be responsible to independently work with customers and provide them with the necessary and requested regulatory information in accordance with customer specific guidelines and various US and international regulations.

Job Responsibilities

• To independently prepare customer documentation to satisfy customer requests. This function requires knowledge of specific customer, US FDA Food/Flavor &State Regulations. Specific documents include: Natural Certification, FDA/FEMA-GRAS Certifications, Allergen Letters, Food Grade Certifications, GMO Certification, BSE, Pesticides and Heavy Metals Certifications, Continuing Food Guarantee, Country of Origin Certifications, Customer Questionnaires, Nutritional, Organic, Country Permissibility and other appropriate documents.

• Support the management in other regulatory tasks (including special projects) and identify areas of improvement and increased efficiency.

• Participate in company audits (internal, customer and regulatory agencies)

• Manage all company quality documentation including vendor approval documentation.

• Interface with all company departments to satisfy customer requests.

• Complete and in-depth investigations of any problems or issues that may arise

Qualifications

Knowledge and Experience Requirements:

• BS in Chemistry, Food Science, Food Technology, or other related science fields.

• Knowledge of basic chemistry and mathematics is essential.

• Proficient in computer knowledge (Microsoft Office Suite), including database management, spreadsheet creation, internet navigation skills, and scientific/technical writing skills.

• Must be skilled in analytical thinking, highly organized, well equipped for changing tasks, and an able to work in a collaborative and independent environment.

• Maintain a high quality of work for the company and for our customers which requires the ability to complete tasks through verbal and written instructions in a prompt manner to meet stringent deadlines.

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