Head of Regulatory Affairs
5 days ago
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.
-
Head of Regulatory Affairs
1 week ago
Mumbai, Maharashtra, India Jones Recruit Zo Full timeJob 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...
-
Mumbai, Maharashtra, India Jones Recruit Zo Full timeJob 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...
-
Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India BEST-FIT Recruitment Riders Full timeJob Profile:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at BEST-FIT Recruitment Riders. The ideal candidate will have a strong background in regulatory affairs, with experience in product registration, CTD format preparation, and regulatory submission.Key Responsibilities:Prepare and submit product registration documents to...
-
Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India BEST-FIT Recruitment Riders Full timeJob Profile:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at BEST-FIT Recruitment Riders. The ideal candidate will have a strong background in regulatory affairs, with experience in product registration, document preparation, and submission to regulatory authorities.Responsibilities include collection and preparation of...
-
Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India Piramal Group Full timeJob Title: Regulatory Affairs Specialist Job Summary: We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Piramal Critical Care. The successful candidate will be responsible for managing regulatory filings for Europe, ensuring compliance with eCTD requirements, and providing support to the Pharmacovigilance team. Key...
-
Regulatory Affairs Manager
1 week ago
Mumbai, Maharashtra, India 1925 GlaxoSmithKline LLC Full timeJob DescriptionAs a Regulatory Affairs Manager at 1925 GlaxoSmithKline LLC, you will be responsible for leading global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously. You will interpret and advise teams on global guidelines, procedures, and...
-
Regulatory Affairs Manager
2 weeks ago
Mumbai, Maharashtra, India 1925 GlaxoSmithKline LLC Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs professional to join our team as a Regulatory Affairs Manager. As a key member of our Regulatory Affairs department, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects...
-
Regulatory Affairs Specialist
2 days ago
Mumbai, Maharashtra, India 1925 GlaxoSmithKline LLC Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at 1925 GlaxoSmithKline LLC.About the RoleAs a Regulatory Affairs Specialist, you will be responsible for ensuring the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital...
-
Regulatory Affairs Leader
2 weeks ago
Mumbai, Maharashtra, India General Mills Full timeJob Title: Regulatory Affairs LeaderAt General Mills, we are committed to making food the world loves. As a Regulatory Affairs Leader, you will play a critical role in ensuring that our products meet the highest standards of quality and safety.Key Responsibilities:Monitor regulatory changes and status in GEMS multiple markets (India, Middle East, Southeast...
-
Regulatory Affairs Specialist
2 days ago
Mumbai, Maharashtra, India Genpact Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Genpact. As a Lead Regulatory Affairs Expert, you will play a critical role in ensuring compliance with labeling regulations and guidelines.Key ResponsibilitiesLiaise with key interfaces to ensure project requirements are met and timelines are mutually...
-
Regulatory Affairs Associate Manager
2 weeks ago
Mumbai, Maharashtra, India Kenvue Full timeJob Title: Associate Manager, Regulatory AffairsKenvue is a leading consumer healthcare company that is currently recruiting for an Associate Manager, Regulatory Affairs position. This role reports to the Director-Regulatory Affairs and is based in Mumbai.About KenvueKenvue is a global company that is built on over a century of heritage and rooted in...
-
Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India Ipca Laboratories Limited Full timeJob Title: Regulatory Affairs ExecutiveIpca Laboratories Limited is seeking a highly skilled Regulatory Affairs Executive to join our team.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance with US FDA guidelines.Prepare and submit registration dossiers, renewal applications, and variations as per regulatory...
-
Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India Ipca Laboratories Limited Full timeRegulatory Affairs Executive - USA MarketIpca Laboratories Limited is seeking a highly skilled Regulatory Affairs Executive to join our team in the USA market.Key Responsibilities:Prepare registration dossiers in accordance with US Regulatory guidelines.Develop and submit renewal applications as per Renewal guidelines.Respond to queries raised by regulatory...
-
Regulatory Affairs Specialist
2 days ago
Mumbai, Maharashtra, India Parexel Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Consultant to join our team at Parexel.As a Regulatory Affairs Consultant, you will be responsible for handling the life cycle management of approved drug products, including tablets, syrups, and parenterals.You will lead and contribute to the planning, preparation, and delivery of regulatory...
-
Regulatory Affairs Manager
2 weeks ago
Mumbai, Maharashtra, India 1925 GlaxoSmithKline LLC Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at 1925 GlaxoSmithKline LLC. As a key member of our regulatory affairs team, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams...
-
Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India ITEX Full timeAbout ITEX: As a global leader in producing high-tech medical and aesthetic devices, we are committed to innovation and excellence. Our company has offices and manufacturing facilities in the USA, UK, Bratislava, India, and other countries, making us a truly international organization.Job Overview: As a Regulatory Affairs Specialist, you will play a crucial...
-
Regulatory Affairs Specialist
3 days ago
Mumbai, Maharashtra, India Piramal Group Full timeBusiness: Piramal Critical Care Department: Regulatory AffairsLocation: Kurla, MumbaiTravel: LowJob OverviewAs a Regulatory Affairs Specialist, you will be responsible for managing Regulatory Filings for Europe with minimal supervision.Key Stakeholders: InternalCountry manager, Plant, QA, Artwork department, Supply Chain, PVKey Stakeholders: ExternalHealth...
-
Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India Apotex Full timeAbout Apotex Inc.Apotex Inc. is a global health company that produces high-quality, affordable medicines for patients worldwide. With a presence in over 75 countries, Apotex employs almost 7,200 people in manufacturing, R&D, and commercial operations. The company is focused on developing and selling generic, biosimilar, and specialty products through...
-
Regulatory Affairs Manager
2 weeks ago
Mumbai, Maharashtra, India Piramal Group Full timeBusiness: Piramal Pharma SolutionsDepartment: Corporate Regulatory AffairsLocation: GlobalTravel: LowJob OverviewAs a key member of the Corporate Regulatory Affairs team, you will be responsible for the submission of regulatory dossiers for targeted markets as per business needs to support CDMO and Agile businesses.Key Responsibilities• Compilation and...
-
Regulatory Affairs Manager
2 weeks ago
Mumbai, Maharashtra, India Piramal Group Full timeJob OverviewPiramal Pharma Solutions is seeking a highly skilled Regulatory Affairs professional to join our Corporate Regulatory Affairs team. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our products in the US, EU, and Canada.Key ResponsibilitiesCompilation and submission of...