18 Regulatory Databases Jobs

As an Assistant Manager in Regulatory Affairs at our Haridwar factory, your role will focus on Technical Regulatory Affairs in the Personal Care - Cosmetics/Ayurvedic industry. You will report to the Head of QA & QC and be responsible for the following key activities: - Reviewing product formulations in compliance with Indian FDA (Cosmetics & Ayurvedic) regulation, EU Cosmetics Regulation (EC 1223/2009), US FDA, ASEAN, and GCC guidelines. - Preparing and maintaining regulatory dossiers such as Product Information Files (PIF) and safety assessments as per export requirements. - Ensuring product labels, ingredient lists, and claims adhere to country-specific regulations. - Preparing Products S...

Role Overview: As an LCA Expert at BMW TechWorks India, you will play a crucial role in leading Life Cycle Assessment activities to support sustainability initiatives within BMW's Vehicle Footprint program. You will collaborate with cross-functional teams to analyze components and processes, generate robust CO2e calculations, and ensure accurate material content for multiple vehicle configurations. Your work will contribute to material restrictions evaluation, regulatory reporting requirements, and continuous process improvements within the sustainability/LCA domain. Key Responsibilities: - Lead LCA activities using GaBi software to support sustainability initiatives within BMW's Vehicle Foo...

As a Regulatory Affairs Consultant specializing in lipid-based pharmaceutical products, particularly Fish Oil Triglycerides like EPA/DHA omega-3 fatty acids, you will be responsible for providing regulatory support and strategic guidance for drug, dietary supplement, or nutraceutical products containing fish oil derivatives. Your expertise will ensure compliance with global regulatory standards, including FDA (CDER & CFSAN), throughout the development, manufacturing, and commercialization process. **Key Responsibilities:** - Develop and implement regulatory strategies for lipid-based products derived from fish oil triglycerides for the US market. - Prepare, review, and manage regulatory subm...

As a Regulatory Toxicology & Pharmacology professional at our company in Kolkata, your role will involve the following: - Clear understanding of Regulatory Toxicology & Pharmacology principles with robust domain knowledge - Good understanding of OECD guidelines Safety Guidelines - Familiarity with risk assessment, Hazard assessment, Exposure assessment & Safety assessment - Knowledge of various Toxicology/ Pharmacology/ clinical/ Regulatory databases - Knowledge of dose calculation & conversions - Capability of interpretation of results and analysis of key toxicity data Qualifications required for this role are: - M. Pharm in Pharmacy - MS/M.Sc(Science) in Chemistry,

As a Regulatory Affairs Executive (Packaging & Labeling) at Meghmani Lifesciences Ltd, you will play a crucial role in ensuring compliance with regulatory requirements and maintaining regulatory documentation. Your responsibilities will include: - Preparing and maintaining regulatory documentation - Coordinating with various departments to gather necessary information - Reviewing and ensuring that packaging and labeling meet regulatory standards - Acting as a bridge between Vendors, Studio/Design Team, Marketing, QA, and Supply Chain - Ensuring timely finalization of artwork & packaging materials - Coordinating on label claims & regulatory compliance - Overseeing the printing & packing for F...

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com. Job Summary Responsible for the product life-cycle management of Apotex products (Toronto) in identified markets. Maintenance of documentation/database records pertaining to approved products in l...

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com. Job Summary Responsible for the product life-cycle management of Apotex products in US and ...

JOB TITLE- ASSISTANT MANAGER (REGULATORY AFFAIRS) DEPARTMENT- REGULATORY AFFAIRS INDUSTRY- PERSONAL CARE - COSMETICS / AYURVEDIC LOCATION- HARIDWAR FACTORY ROLE- TECHNICAL REGULATORY AFFAIRS REPORTS TO HEAD QA & QC RESPONSIBILITIES: Review Product formulation as per Indian FDA (Cosmetics & Ayurvedic) regulation, EU Cosmetics Regulation (EC 1223/2009), US FDA, ASEAN, and GCC guidelines. Prepare and maintain regulatory dossiers as Product Information Files (PIF), and safety assessments as per Export requirements. Review product labels, ingredient lists, and claims to ensure adherence to country-specific regulations. Preparation of the Product's Safety Data Sheet as per export regulations. Keep...

Primary Job Function To lead and manage all regulatory affairs activities at the manufacturing site located at Mumbai and LL locations, ensuring timely regulatory submissions, compliance with regulations, and providing strategic support to institutional and international business operations. The role is critical to maintaining business continuity and regulatory compliance. Core Job Responsibilities Regulatory Submissions and compliance Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes e...

As an Assistant Manager in Regulatory Affairs at our Haridwar factory, your primary role will be to review product formulations in accordance with Indian FDA (Cosmetics & Ayurvedic) regulation, EU Cosmetics Regulation (EC 1223/2009), US FDA, ASEAN, and GCC guidelines. Your responsibilities will include preparing and maintaining regulatory dossiers such as Product Information Files (PIF) and safety assessments to meet export requirements. You will also be tasked with reviewing product labels, ingredient lists, and claims to ensure compliance with country-specific regulations. Additionally, you will be responsible for preparing Product Safety Data Sheets as per export regulations and staying u...

As a Regulatory Toxicology & Pharmacology professional in Kolkata, you will be expected to have a clear understanding of Regulatory Toxicology & Pharmacology principles with robust domain knowledge. Additionally, you should possess a good understanding of OECD guidelines Safety Guidelines and be familiar with risk assessment, Hazard assessment, Exposure assessment & Safety assessment. Your role will also require knowledge of various Toxicology/ Pharmacology/ clinical/ Regulatory databases and dose calculation & conversions. With 2-3 years of experience, you should have the capability of interpretation of results and analysis of key toxicity data. Qualifications required for this position inc...

Job Position: Cosmetics Regulatory Affairs Specialist Working Days: Monday to Friday Shift Time: 12 PM IST- 9 PM IST We are looking for a detail-oriented and knowledgeable Cosmetics Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong understanding of regulatory policies, documentation, and compliance requirements related to cosmetics. This role will be responsible for ensuring that all products meet local and international regulatory standards. Key Responsibilities: ? Prepare and submit regulatory documentation for cosmetic product approvals and registrations. ? Ensure compliance with all relevant regulations, guidelines, and standards related to cosmetics....

About Role: On offer is the opportunity to develop in a young and rapidly growing pharmaceutical company, Key Pharmaceuticals. The organisation operates as a virtual generics company which holds its own marketing authorisations (primarily oral dosage forms) within the United Kingdom/United Arab Emirates and a manufacturing/importation authorisation. Key Pharmaceuticals is part of the Bestway Healthcare Group, a vertically integrated business. Requirements: Minimum 7+ years experience within the pharmaceutical industry R & D and EU regulatory background preferred Proven history of CMC, dossier compilation and submission to UK and EU. Understanding of pharmacovigilance and compliance requireme...

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary Compilation and submission of new registration applications, deficiency respon...

ApoPharma, a member of the Apotex group of companies, is a pharmaceutical company devoted to the discovery, development and provision of new medicines to help improve the quality of life of patients with debilitating and life-threatening diseases. Investigation into the pathological role of iron in human disease, and how to use novel medicines to treat conditions created or worsened by iron, is a major research focus of ApoPharma. Job Summary Responsible for the product life-cycle management of Apotex products (Toronto) in identified markets. Maintenance of documentation/database records pertaining to approved products in line with systems, processes and procedures. Preparation of submission...

As a Cosmetic Regulatory Affairs Assistant at our company in Jodhpur, you will play a crucial role in ensuring that our cosmetic products meet all regulatory requirements and standards. Your attention to detail and proactive approach will be essential in supporting the Regulatory Affairs department. Key Responsibilities: - Ensure compliance with all relevant regulatory standards and guidelines. - Monitor changes in legislation and the regulatory environment, and take necessary actions. - Assist in collecting and reviewing raw material documents. Qualifications & Skills: - Bachelor's degree in Pharmacy, Chemistry, Cosmetic Science, or a related field. - Previous experience in regulatory affai...

JOB DESCRIPTION: Primary Job Function: To lead and manage all regulatory affairs activities at the manufacturing site located at Mumbai and LL locations, ensuring timely regulatory submissions, compliance with regulations, and providing strategic support to institutional and international business operations. The role is critical to maintaining business continuity and regulatory compliance. Core Job Responsibilities: Regulatory Submissions and compliance Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post...

Key Responsibilities Intelligence Gathering & Analysis Monitor and analyze the global regulatory landscape for assigned therapeutic or regional areas Compile and synthesize new or updated regulatory requirements from local affiliates Prepare deliverables such as monitoring reports, bulletins, and landscape summaries Ensure outputs are clear, actionable, and aligned with business needs Provide insights or recommendations to inform filing strategies and compliance planning Tools & Data Management Manage and maintain regulatory intelligence tools, databases, and repositories Ensure systems are up-to-date and easily accessible by stakeholders Build or configure new dashboards, tracking tools, or...