Assistant Manager - Regulatory Affairs IMPRONICS DIGITECH PRIVATE LIMITED

3.0 - 7.0 years

0 Lacs

maharashtra

On-site

The ideal candidate for this role should possess a minimum education qualification of M. Pharmacy. You will be responsible for handling regulatory activities such as CTD dossier preparation, query resolution, and ensuring compliance with ICH guidelines and current regulatory standards. Your primary market focus will be on the Africa market, specifically in regions like Zazibona, South Africa, East Africa (Kenya, Tanzania, Ethiopia, etc.), and FWA. Your key responsibilities will include: - Preparation and submission of new dossiers - Conducting gap analysis of dossiers for completeness - Compiling dossiers in eCTD format for submission to various regulatory authorities - Coordinating dossier submissions in different countries - Evaluating and responding to queries, including coordination with manufacturers and final compilation of responses - Managing post-approval activities such as product lifecycle management, variations, and renewals - Monitoring harmonization of dossiers, queries, and variations across all countries - Developing artworks and obtaining approvals as per standard operating procedures - Engaging in daily communication with internal departments and external stakeholders - Updating trackers for queries and variations regularly - Attending unit and regional meetings, trainings, and other relevant sessions as required by the line manager and Intellectus Campus. Your role will require strong technical expertise in regulatory affairs, excellent communication skills, attention to detail, and the ability to manage multiple tasks while ensuring deadlines are met. Your proactive approach to problem-solving and ability to collaborate with various stakeholders will be crucial for success in this position.,

Posted 2 weeks ago

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Officer Srikrishna pharmaceuticals

3.0 - 7.0 years

0 Lacs

hyderabad, telangana

On-site

As an Officer in Packaging Development at M/S Sri Krishna Pharmaceuticals since October 2023, your role involves the development of primary, secondary, and tertiary packaging materials for solids and semisolids. Additionally, you are responsible for creating new blister change parts based on customer and market requirements. Your tasks also include the development of artworks for labels, cartons, foils, medication guides, and PILs for Regulatory Filling. Collaboration is a key aspect of your job, as you regularly interact with R&D, Regulatory Affairs, production, Marketing/ Business Development, and Supply Chain Management departments to gather necessary information for artwork development. You are also accountable for reviewing artworks to ensure compliance with market, regulatory, and customer requirements. In this role, you will be preparing and reviewing Bill of Materials, Packaging Material Specifications, standard test procedures, master packaging cards, and other technical documents. You will also be involved in the preparation and execution of protocols and reports, as well as in the creation of case labels and logistic data for sharing with customers and marketing teams. Your responsibilities extend to initiating and obtaining approval for change controls in the Quality Assurance Management System (QAMS) and developing action plans within target dates. You will provide support for the implementation of Track & Trace systems such as DGFT, EUFMD, and US DSCSA, and assist vendors in the development of new materials and designs. Furthermore, your role involves conducting machine trials to evaluate machine and materials compatibility for new and existing materials. You will also troubleshoot any problems that arise in the packing area to ensure smooth operations and quality output.,

Posted 2 weeks ago

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Manager - Packaging Development Dhathri Ayurveda

5.0 - 10.0 years

5 - 7 Lacs

Ernakulam, Kerala

Work from Office

Educational Qualification: B.Tech in Packaging Technology or related field (Preferred) Key Responsibilities: Develop and implement primary, secondary, and tertiary packaging for Personal Care, Skin Care, and Hair Care products. Drive innovation in packaging forms to enhance delivery and achieve cost optimization. Identify and adopt new packaging materials as per product functionality and customer needs. Develop new vendors , conduct audits, and ensure timely, cost-effective deliveries. Prepare and maintain packaging specifications, SOPs, STPs, and Bill of Materials (BOM) . Evaluate and implement new technologies or machinery for process efficiency and packaging quality improvement. Plan and ensure quality checks of packaging materials via internal/external labs. Regularly review packaging costs and processes to minimize waste and optimize performance . Coordinate artwork development , print proof approvals, and shade card finalization. Handle monthly planning, indenting, vendor coordination , and inventory monitoring. Monitor and generate quality reports of incoming packaging materials. Provide technical inputs during product development for packaging feasibility . Candidate Profile: Proven experience in packaging development in cosmetics, personal care, or FMCG sector. Strong understanding of packaging materials, vendors, cost control, and artwork coordination. Proactive, detail-oriented, and able to handle end-to-end packaging lifecycle .

Posted 1 month ago

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