Regulatory Affairs Manager

4 days ago

Indore, India H&H Healthcare and Cosmetics Private Limited Full time

Company Description

H&H Healthcare and Cosmetics Private Limited is dedicated to bringing health, care, and wellness through nutraceutical, herbal, food, and beauty products. The company focuses on nutraceutical third-party manufacturing with technological categories like powders, tablets, capsules, and herbal-based products. Early life nutrition and medical nutrition are at the core of the business, aiming to support the community's health and well-being.

Role Description

This is a full-time Regulatory Affairs Specialist role located on-site. The Regulatory Affairs Specialist will be responsible for handling regulatory documentation, ensuring compliance with regulatory requirements, and preparing and submitting regulatory documents, Responsible for adjusting the quantity of each ingredient in formulation according to nutraceutical standards as per FSSAI for domestic market and as per country specific guidelines for international market.

I also check & give approval to other departments for the use of these ingredients in their formulations, irrespective of whether they have been approved by FSSAI, as well as Ayush or not

Calculation of RDA and RDA% as per current FSSAI norms as well as export market.

Ensure that all product labels and packaging adhere to FSSAI labelling regulations, including ingredient lists, nutritional information, and allergen declarations.

Check the quality documentation like DTM, for artwork.

Supervision the artwork for printing.

Stay updated with any changes or amendments in FSSAI regulations and circulate to the concern stakeholders and ensure prompt implementation within the organization.

Review the client's inquiry given by BD Department and suggest modifications in accordance with FSSAI regulations and country specific.

Review the Product Information File (PIF) to proceed with the document for taking trial.

Declaration letter and Material Safety Data Sheet (MSDS) are prepared for the sample transportation.

Qualifications

  • Regulatory Documentation and Regulatory Submissions
  • Regulatory Compliance and Regulatory Requirements
  • Experience in regulatory affairs
  • Attention to detail and strong analytical skills
  • Ability to work effectively in a team
  • Knowledge of industry regulations and guidelines
  • Bachelor's degree in a related field, such as Pharmacy, Chemistry, Biology, or a similar discipline

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