Job Description

Department : Regulatory Affairs

Designation : Officer/Executive

R.A Officer/Executive in a Gummies Manufacturing Company would play a crucial role in ensuring that the company's products comply with all regulations and laws governing the manufacturing, marketing, and distribution of food supplements. Here's a detailed job description:

Key Responsibilities:

• Regulatory Compliance & HALAL Certification:

o Ensure that the company's gummy products comply with national and international regulations (e.g., FSSAI, WHO, USFDA and other Indian Regulatory Authorities) for food supplements/ Pharma.

• Stay updated on new and emerging regulations and standards applicable to the gummy industry.
• Assist in the preparation of food or drug regulatory documentation, submissions, and knowledge of dossiers for export preparation as required by local and international regulatory bodies.

o Ensure all products, ingredients, and processes comply with Halal certification standards.

o Coordinate with Halal certification authorities for audits, renewals, and updates

o Maintain documentation and records required for Halal complianc.

• Documentation and Submissions:
• Prepare, compile, and submit regulatory documents for product registration, amendments, renewals, or approvals.
• Manage the submission of technical dossiers, including product specifications, ingredients, manufacturing processes, and packaging details.
• Maintain accurate and up-to-date records of all regulatory documents.
• Product Labelling and Packaging:
• Review and approve product labels and packaging to ensure they meet regulatory requirements related to health claims, nutritional information, and allergen labeling.
• Ensure the accuracy of product labeling and marketing materials to prevent any legal or compliance issues.
• Cross-Functional Collaboration:
• Work closely with the R&D, Quality Assurance, and Production teams to ensure compliance with regulatory standards during the product development process.
• Provide regulatory input during new product development to ensure that formulations, ingredients, and processes meet regulatory standards.
• Audit and Inspection:
• Coordinate and assist during regulatory inspections and audits by authorities like the Food Safety and Standards Authority of India (FSSAI) or other local and global regulatory bodies.
• Prepare and implement corrective actions for any non-compliance issues identified during audits.
• Risk Management:
• Identify and mitigate regulatory risks associated with product manufacturing and distribution.
• Keep management informed about regulatory risks, changes, and updates that may impact the business.
• Liaison with Authorities:
• Act as a point of contact with regulatory authorities, handling communications, responses to inquiries, and providing them with required information.
• Training and Education:
• Train staff on regulatory requirements and compliance processes.
• Educate internal teams on current and upcoming regulatory developments that may impact the company.

Educational Qualifications:

• Bachelor's or Master's degree in a related field such as:
• Pharmaceutical Science
• Biotechnology
• Food Science and Technology
• Chemistry
• Microbiology
• Life Sciences
• Pharmacy (B. Pharm or M. Pharm)
• Some positions may require specific certification in regulatory affairs or courses related to the field.

Skills and Experience:

Experience:

o 2 + years years of experience in regulatory affairs, preferably in the food, nutraceutical, or pharmaceutical industry & Must have HALAL Certification and complete knowledge

o Experience with regulatory bodies such as FSSAI, or international equivalents is highly valued.

Knowledge:

o Thorough understanding of food safety regulations, Must have HALAL Certification and complete knowledge

o labeling requirements, and import/export laws in India.

o Familiarity with international regulations (e.g., USFDA food regulations) if the company exports products.

Skills:

o Strong attention to detail and analytical skills for reviewing and compiling regulatory documentation.

o Good communication and negotiation skills for liaising with regulatory authorities.

o Ability to work under tight deadlines and manage multiple projects.

This role is essential for ensuring the company meets all legal and regulatory obligations, thereby maintaining the safety and efficacy of its products while avoiding legal penalties.

Job Types: Full-time, Permanent

Pay: ?20,000.00 - ?40,000.00 per month

Benefits:

• Health insurance
• Leave encashment
• Paid sick time
• Provident Fund

Schedule:

• Day shift

Supplemental Pay:

• Yearly bonus

Experience:

• total work: 1 year (Preferred)

Work Location: In person