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Title:  Manager - 2

Date:  Jul 11, 2024
Location:  Tandalja - R&D
Company:  Sun Pharmaceutical Industries Ltd

Job Title:

Manager-1/ Manager-2

Job Grade (refer to JE)

G10/ G11A

Function:

India Regulatory Affairs

Sub-function:

IRA

Function Head Title:

Sr. GM

Location:

Tandalja, Vadodara

No. of Direct Reports (if any)

2

Business Unit:

 

 

 

 

Job Summary

Regulatory Submissions of products at Food Safety and Standard Authority of India (FSSAI), Legal Metrology, Bureau of Indian Standard (BIS).

License and Label compliance of products falls under the purview of FSSAI. 

 

Areas Of Responsibility

  • Regulatory assessment and validation of all products falls under the purview of FSSAI with respect to RDA compliance, label claim, categorization of the products for In-House as well as third party. 
  • To ensure label compliance with respect to FSS (Labelling and Display) Regulations, 2020, Legal Metrology (Package commodity) Regulations, 2011 and their amendments.
  • To ensure product claims, health claims and nutrient claims of Food/ Health supplements/ Nutraceuticals/ FSDU/FSMP/Pre-Probiotic product and application for claim approval from FSSAI.
  • License compliance of Food Products with respect to categories for Head Office license/ Registered Office/ Manufacturing License/ Relabeller License/Import License/ all CNF licenses.
  • Review and ensure the compliance of Finished Product Specification, Stability Data, NABL COAs, water analysis report.
  • Application for the New Product/ Ingredient approval under the Food Safety and Standards (Approval for Non-Specified Food and food Ingredients) Regulations, 2017, Legal Metrology, Bureau of Indian Standard (BIS).
  • Ensuring Annual Return Filling of Food Product to FSSAI for Import, In House Manufacturing Product and also for the Relabeller Products.
  • Handle Market query / complaint from Authorities/ ASCI/ Consumers.
  • Evaluate the impact of changes in FSS and Legal Metrology Rules/ Regulations in existing products and in upcoming products.
  • Provide comments/ suggestions on the New FSS Regulations/ Legal Metrology (Package commodity) Regulations, 2011 and submit Representation to Authorities as per requirement.
  • Provide comments on the Draft of FSS Rules/ Regulations, Legal Metrology (Package commodity) Regulations, 2011 and Other Regulations.
  • To evaluate and provide comments/approvals on the TVC, Audio- Visual Ad, Posters etc. for consumer health care products.

 

Travel Estimate

Only if required

         

 

Job Scope

Internal Interactions (within the organization)

Co-ordinate with the FRD, CQA, ADD, Manufacturing Plant, Medical, Marketing etc. as per requirement.

External Interactions (outside the organization)

Co-ordinate with the Third- Party manufacturer’s for product, label and license compliance. 

Geographical Scope

India

Financial Accountability (cost/revenue with exclusive authority)

 

 

Job Requirements

Educational Qualification

M. Pharm / M. Sc.

Specific Certification

 

Experience

8- 10 yrs

Skill (Functional & Behavioural):

 

 

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