Looking Regulatory Affairs - Sr. Manager/Manager & Sr. Executive -

No of Vacancies - 2

Designation : Sr. Manager/Manager

Educational

Qualification : M.Sc / M.Pharma Total

Experience : 8-10 years

(Pharma API/Food/Nutraceuticals)

JOB DESCRIPTION

1. Preparation, review and submission of high quality Drug Master File and certificate of

suitability applications for Active Pharmaceutical Ingredients for submission to EDQM,

USFDA and RestOf

- World regulatory authorities.

2. Expertise to have preparation and review of Drug Master File for Fermentation and

biotechnological based API.

3. To review the Process validation, Analytical method validation, Stability protocols and

reports with special emphasis on regulatory ramifications.

4. Effective communication with customer by providing open part DMF, technical

package, query response, to ensure the product registration throughout the world.

5. Ensure timely submission via Annual report and Amendments in US, CEP

variation/ASMF Amendments in EU for the drug substances registered.

6. To participate in the vendor development assignment with respect to the exact and

precise denomination of product specification and registration commitments.

7. To review change control and submission of post approval changes to respective Drug

Master Files and countries.

8. Should have knowledge on FSSAI License, BRC, ISO 22000 and FSSC 22000

certification and preparation of documents and managing the application process for

Halal and Kosher Certifications.

9. Providing technical support to the research and development team during new product

formulations, and to the Sales and Marketing Team regarding product specifications.

10. Knowledge of facility registration and renewal with USFDA and staying current with

regulatory developments and trends impacting the nutraceutical industry.

Designation : Sr. Executive/Executive

Educational

Qualification : M.Sc/ M.Pharma Total

Experience : 3-5 years

(Food/Nutraceuticals/Pharma API)

JOB DESCRIPTION

1. Preparation of documents required for new FSSAI License, including website

registration and license application.

2. Classification of products according to Food Safety and Standards Regulations (Food

or Health Supplements and Nutraceuticals), and compliance with FSSR and other

relevant amendments and documentation.

3. Finalization of label artwork to ensure compliance with FSSR (Labelling and Packaging)

regulations and other amendments for Nutraceutical Foods.

4. Providing technical support to the research and development team during new product

formulations, and to the Sales and Marketing Team regarding product specifications.

5. Ensuring food product and raw materials meet standards as per FSSR (Food product

Standard and Food Additives) 2011 and other relevant amendments.

6. Demonstrating strong knowledge of food safety regulations (e.g., FDA, USFDA

regulations) and industry standards (e.g., GMP, HACCP, ISO 17025), as well as GFSI

compliance requirements including BRC, ISO 22000 and FSSC 22000 certification.

7. Preparation of documents and managing the application process for Halal and Kosher

Certifications.

8. Knowledge of facility registration and renewal with USFDA.

9. Managing regulatory submissions and liaising with regulatory agencies to secure

necessary approvals.

10. Staying current with regulatory developments and trends impacting the nutraceutical

industry.

Interested candidates please share their cv at jai.mirchandani@symbiotec.in