Head of Regulatory Affairs

4 weeks ago

Mumbai, Maharashtra, India Jones Recruit Zo Full time

Job Title: Head - Regulatory Affair - Pharma

Job Description:

Job Summary:

The Head of Regulatory Affairs will be responsible for overseeing all regulatory aspects of our product development, manufacturing, and marketing processes. This role involves ensuring compliance with the Food Safety and Standards Authority of India (FSSAI), Legal Metrology, the Advertising Standards Council of India (ASCI), and managing Extended Producer Responsibility (EPR) under the Central Pollution Control Board (CPCB). A significant focus of this role will be on ensuring rigorous label compliance, a critical aspect of regulatory affairs in the nutraceutical industry.

Key Responsibilities:

Label Compliance:

- Ensure that all product labels meet FSSAI, Legal Metrology, and ASCI standards, including accurate ingredient listing, nutritional information, claims, and warnings.

- Review and approve label designs and content to ensure they comply with regulatory requirements and reflect the company's branding and marketing strategies.

- Develop and maintain a comprehensive label compliance program, including guidelines and best practices for label creation and review.

- Conduct regular audits of product labels to ensure ongoing compliance and address any discrepancies or updates required due to regulatory changes.

- Act as the point of contact for any label-related inquiries or issues from regulatory authorities and ensure timely resolution.

Regulatory Compliance:

- Ensure all products and processes comply with FSSAI, Legal Metrology, and ASCI regulations.

- Oversee the preparation and submission of regulatory documents, including product registrations, licenses, and approvals.

- Monitor regulatory changes and assess their impact on the company's products and operations.

Extended Producer Responsibility (EPR):

- Manage and implement EPR obligations under CPCB, ensuring compliance with guidelines related to waste management and recycling.

- Develop and execute strategies to meet EPR targets, including collection, segregation, and recycling of packaging waste.

- Maintain records and prepare reports related to EPR activities, ensuring timely submission to CPCB.

- Coordinate with waste management partners and stakeholders to ensure efficient and compliant waste disposal and recycling practices.

Strategic Planning:

- Develop and implement regulatory strategies to support product development and market entry.

- Provide strategic advice on regulatory requirements and risk management to senior management and other Collaboration

- Work closely with R&D, manufacturing, quality assurance, and marketing teams to ensure regulatory compliance throughout the product lifecycle.

- Liaise with regulatory authorities and industry associations to address regulatory issues and stay updated on best practices.

Regulatory Submissions and Reporting:

- Lead the preparation of regulatory submissions, including dossiers, technical documents, and compliance reports.

- Ensure timely and accurate reporting of regulatory affairs to internal stakeholders.

Training and Development:

- Develop and deliver training programs on regulatory requirements and compliance best practices for internal teams.

- Stay current with industry trends and regulatory developments, and share knowledge with the team.

Issue Resolution:

- Address and resolve regulatory issues, including non-compliance incidents, LM queries, and regulatory inquiries.

- Implement corrective and preventive actions as needed to maintain Skills and Qualifications:

- Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, Environmental Science, or a related field. Advanced degree preferred.

- Minimum of 7 years of experience in regulatory affairs within the nutraceuticals, pharmaceuticals, or related industry.

- In-depth knowledge of FSSAI, Legal Metrology, ASCI regulations, and Extended Producer Responsibility (EPR) guidelines under CPCB.

- Excellent communication skills is mandatory. You have to be able to represent yourself in front of senior individuals at Plix, regulatory authorities, and at Marico.

- Proven track record of successful regulatory submissions and interactions with regulatory bodies.

- Strong expertise in label compliance, with a thorough understanding of regulatory requirements for nutraceutical labels.

Company Overview:

Jones Recruit Zo is a leading recruitment agency that specializes in placing top talent in the nutraceutical and pharmaceutical industries. We are committed to providing our clients with exceptional service and expertise in finding the best candidates for their needs.

Working at Jones Recruit Zo:

At Jones Recruit Zo, we believe in creating a work environment that is collaborative, dynamic, and rewarding. We offer our employees a range of benefits and opportunities for growth and development, including comprehensive training and professional development programs, competitive salaries and benefits, and a fun and supportive work culture.

Apply Now:

Apply now to join our team and take the first step in your career as a regulatory affairs expert. If you are a motivated and experienced professional looking to make a difference in the nutraceutical and pharmaceutical industries, we encourage you to apply for this exciting opportunity.

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