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0.0 years
0 Lacs
navi mumbai, maharashtra, india
On-site
ob Summary: The Regulatory Operations Specialist will be responsible for managing and executing regulatory strategies, submissions, and compliance activities across the Asia-Pacific (APAC) region. This role ensures that products meet all regulatory requirements for market access, lifecycle management, and post-market surveillance. The position involves cross-functional collaboration, regulatory intelligence monitoring, and direct engagement with health authorities. Key Responsibilities: Regulatory Strategy & Execution Develop and implement regulatory strategies for product registration and lifecycle management across APAC.Monitor and analyze regulatory changes and assess their impact on prod...
Posted 1 month ago
3.0 - 7.0 years
0 Lacs
hyderabad, telangana
On-site
As an experienced Regulatory Affairs Consultant with specialized knowledge in lipid-based pharmaceutical products, particularly Fish Oil Triglycerides such as EPA/DHA omega-3 fatty acids, your role will involve providing regulatory support and strategic guidance for drug, dietary supplement, or nutraceutical products containing fish oil derivatives to ensure compliance with global regulatory standards including FDA (CDER & CFSAN). You will be a crucial resource within the organization, offering technical expertise and regulatory guidance for the development, manufacturing, and commercialization of lipid-based pharmaceutical products. Your role will require strong cross-functional collaborati...
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
karnataka
On-site
You will be responsible for ensuring the quality control and assurance processes within the food manufacturing industry. This includes conducting various tests on raw materials and finished products to verify physical, chemical, and microbiological properties, as well as ensuring that they meet established quality standards. Additionally, you will need to ensure compliance with regulatory requirements such as AAFCO, FSSAI, and other relevant standards, while implementing and monitoring Good Manufacturing Practices (GMP). Maintaining accurate documentation and records related to quality control will be a crucial part of your role. This includes keeping track of quality records, online quality...
Posted 2 months ago
5.0 - 9.0 years
0 Lacs
dehradun, uttarakhand
On-site
As a Formulation and Process Development Scientist, you will be responsible for the formulation and process development of Solid Orals, Liquid Orals, and Semi Solids dosage forms. Your main tasks will include designing protocols and development plans for new products, conducting formulation trials, and evaluating stability data to finalize formulation compositions. You will also be involved in tentative costing Bill of Materials (BOM) and trial BOM preparation for trial execution. Additionally, you will prepare supporting documents for stability studies, resolve product stability issues, and develop manufacturing processes for R&D formulations to ensure successful technical transfer for larg...
Posted 2 months ago
7.0 - 10.0 years
9 - 12 Lacs
Pune, Bengaluru
Work from Office
Decision Analytics Consultant - MLR Review (Medical, Legal, and Regulatory) The Consultant for MLR Review in the DCE Marketing Services team is a critical member responsible for overseeing the review and approval of promotional and non-promotional materials. This role demands expertise in the end-to-end Medical, Legal, and Regulatory (MLR) review and submission processes, ensuring compliance with external regulations, industry standards (EFPIA/IFPMA), and company policies. The Consultant collaborates with cross-functional teams to provide regulatory guidance and streamline operations across the MLR landscape. What Youll Do Compliance Advisory: Serve as the lead compliance advisor for designa...
Posted 3 months ago
7.0 - 10.0 years
9 - 12 Lacs
pune, bengaluru
Work from Office
Decision Analytics Consultant - MLR Review (Medical, Legal, and Regulatory) The Consultant for MLR Review in the DCE Marketing Services team is a critical member responsible for overseeing the review and approval of promotional and non-promotional materials. This role demands expertise in the end-to-end Medical, Legal, and Regulatory (MLR) review and submission processes, ensuring compliance with external regulations, industry standards (EFPIA/IFPMA), and company policies. The Consultant collaborates with cross-functional teams to provide regulatory guidance and streamline operations across the MLR landscape. What Youll Do Compliance Advisory: Serve as the lead compliance advisor for designa...
Posted Date not available
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