Responsibilities Detailed Knowledge of regulatory processes in key regions such as India , SEA,LATEM,EU, China, USA for food and food supplements including herbals. Knowledge in working/ representing scientific regulatory issues at regulatory forums in India and global level Knowledge of the broader market understanding and competitor landscape in the space especially infant, pediatric, adult and hospital nutrition segment, food supplements and OTC products. Knowledge of dossier development, and leading project management of regulatory dossiers across multiple markets Leading the cross functional alignment for successful delivery of dossiers across markets including regulatory publishing management Leading regulatory discussions and enabling local country teams with efficient process management while keeping business targets on time. Ability to manage and lead RA-QA interface for India & other markets Ability to integrate the local nuances at design , deploy and maintenance stage of various dossiers across markets Knowledge of the various nuances of the Food & Nutrition Consumer Industry & Market Trends and its application to regulatory strategy and compliance include categorization very clear understanding and interpretation of regulatory laws and guidance including update both and India and US/ EU level   Qualification & Experience Bachelor’s or Master’s Degree Minimum work experience: 10+ years Experience of the complete nutrition and nutraceutical market along-with additional knowledge of Understanding of Food Supplements and their relationship to Human Physiology/ Health/ Diseases Experience in Identifying & Evaluating the new product regulatory strategy during the ideation stage to minimize risks during the product development cycle.  

Responsibilities To dispense drugs / medicines as per requirement / prescriptions. To review prescriptions (in print / online requisitions) to assure accuracy, to ascertain the needed ingredients and to evaluate their suitability. To check stock availability. Arranging medicines as per storage conditions. To provide information and advice regarding drug dosage. To identify expired / near expiry / damaged drugs and prepare a monthly report on expired / near expiry / damaged drugs. To maintain and update records. Indent to Central Stores for non availability of stock. Take a printout of ‘A’ grade items and physically verifying the same. Maintain and control Narcotic drugs as per act and keep a record to it. Hand over cash to cashier.     Qualification & Experience B.Pharmacy / D.Pharmacy Minimum of 2 years in a Hospital OP Pharmacy as a Pharmacist. Freshers too will be considered for this position if they have PCI certificate.   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities Understands regulations, follows complex directions, and investigates regulations when clarification is needed. Develops a working knowledge of the medical device regulations applicable to the devices being supported including, but not limited to: registration, labeling, and post-market surveillance requirements. In alignment with applicable strategies/plans and with support of team members, determines appropriate documentation and testing required for registration of products and coordinates with functional team members to obtain and provide this information. Prepares, organizes, and coordinates data for submission to and manages correspondence with the regulatory agencies. Works with team members to conduct documentation reviews and change assessments including evaluation of effects of regulatory, design, and manufacturing changes, and helps determine required regulatory action (e.g. submissions, notifications). Assists in development, organization, and application of labeling (e.g. instructions for use, marketing materials, package labels, etc.), and may review and provide feedback on labeling and advertisement/promotional material to assure regulatory compliance. Provides regulatory perspective to cross-functional teams (e.g. product development, risk management) to assure products are compliant with relevant US and international medical device standards, codes and regulations. Reports relevant regulation and standards changes and helps determine impact and/or appropriate action. Assures regulatory compliance and content accuracy of technical documentation and submissions. Hands on EU-MDR, 510K, ISO14971:2019, RA Files, IFU, Regulatory submissions Develops an expertise of the medical device regulations for assigned products. Determines applicable strategies /plans for products and works with functional and cross-functional team members to create, obtain, and provide this information. Provides regulatory perspective and expertise to cross-functional teams (e.g. product development, risk management) to assure products are compliant with relevant US and international medical device standards, codes and regulations. Reports relevant regulation and standards changes, determines impact and takes appropriate action. Ensures regulatory compliance of products and processes through participation in process updates. Bio-compatibility knowledge with Standard: 10993-1:2023,Sample Rationalization/Equivalency, Bio comp Evaluation Plan, Chemical Characterization , Biological safety of device End OF Life Evaluation, Gap assessment with latest standard Supports internal and external (third party) audits as required.   Qualification & Experience Bachelor of Science in science and/or engineering field 8 - 12years of regulatory experience in medical device industry (equivalent industry/educational experience may be considered) Thorough working knowledge of applicable FDA, ISO, EU and/or other region-specific medical device regulations, requirements, and standards. Experience in Orthopedics industry preferred.  

Qualification & Experience MBBS 1 to 5 years of experience   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities Responsible for project management support to the scientific writer ensuring the end-to-end effective project delivery of the designated publication/medical education deliverable across all phases. Initiate and amend submission based on comments (as required). Support the writer with internal and external stakeholder communication. Track the delivery of activities (including managing issues and risks) and support follow up. Support required submission, compliance/ approval activities, and ensure compliance with publication processes and end-to-end publication management tools (e.g., iEnvision - previously, Datavision/Matrix) and update as required with approval/compliance tools (e.g., PromoMats, DAM). Support the management of the assigned publication or medical education in line with the agreed budget. Support and manage as required external spend tracking (e.g., approvals, purchase orders, and goods received). Support adherence to associated compliance related activities and approvals (with internal stakeholder taking accountability for compliance). Collaborate effectively with stakeholders: Scientific communication global and/or local teams; and medical content enhancement teams.     Qualification & Experience Experience: 3-5 years post qualification experience Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment Technical skills: Project management; Scientific/Medical writing/communications; Pharma experience (including but not limited to therapeutic area/domain knowledge exposure; and/or publication submission) Education: University degree level (Graduate degree, preferably in science). Additionally, relevant advanced/postgraduate degree in life sciences/pharmacy/similar discipline desirable  

Responsibilities Carry out Analytical method development and pre-validation involved in assigned projects, protocols & reports, in compliance with Ferring QMS to achieve the objectives as per project requirements. Carry Out Author and review Analytical documents, not limited to method development reports, justification reports etc., to be built on strong scientific rationale, study designs & compliance with ICH, compendial & regulatory guidelines. Carry out & Ensure Analytical deliverables for formulation development, optimization & scale-up, as applicable to achieve the objectives as per project requirements. Support Analytical method validation and method transfer involved in assigned projects to achieve the objectives as per project requirements. Carry out Preparation and updating of Specifications, STPs, analytical protocols and reports for assigned projects to achieve the objectives as per project requirements. Carry out & Ensure Managing stability study related activities for assigned projects to achieve the objectives as per project requirements. Ensure Outside analysis co-ordination for routine & characterization tests and report review for assigned projects to achieve the objectives as per project requirements. Carry out Literature search for analytical & regulatory aspects of assigned project to achieve the objectives as per project requirements. Carry out Review of ELN experiments, Data, Reports and documents generated within lab & those received from CRO/CMO in line with defined quality standards. Support Procurement activities related to project & laboratory i.e. vendor contact, URS, SOW etc. in line with defined quality standards. Support Coordinating with Facility/Vendor for instruments and equipment AM, PM and regular maintenance in Analytical lab in line with defined quality standard.     Qualification & Experience Ph.D (preferred), M. Pharma/M.Sc in Pharma Chemistry from reputed University. Experience: M. Pharma/M.Sc in Pharma Chemistry with around 11-14 years of experience or PhD in Pharmaceutical Chemistry/Analytical Chemistry with 6-8 years of experience in analytical development for formulations.  

Responsibilities Responsible for RSL, R&D, VER, Biologics and Synthetic Labs of USP India site for Columns, Equipment spares, consumables, and chemicals Inventory management. To coordinate with all the Labs and submit item code requests to Stores. To coordinate with the Labs and create PR and Move orders for the inventory such as General items, chemicals, and columns in ERP. Responsible to collect the columns/chemicals from Stores as per the move order and to arrange in respective Labs at designated storage areas. Responsible to update the transactions in APEX application for the chemicals and columns To handle the expired chemicals in the Labs and ensure to submit monthly to Stores for disposal. Responsible to issue the columns as per the Labs requirement and receive the columns To perform the physical verification quarterly against the on-hand report for the chemicals and columns To support Central Lab operations in issuance of consumables / spares to the Labs. To take up the additional responsibilities assigned by the supervisor.     Qualification & Experience BSc. Chemistry with 0-1year experience in a reputed Pharmaceutical company. Knowledge on ERP / SAP application will be an added advantage Knowledge on Laboratory compliance (GMP and GLP).  

Responsibilities Lead internal and external cross-functional groups to focus efforts on specific knowledge domains and high-impact topics related to complex generics and complex excipients. Determine deliverables, requirements, and timelines for the development of Complex Generics and complex excipient standards and solutions. Execute against the standards and solutions roadmap through tight integration of activities within USP and with external stakeholders, including but not limited to industry, academia, and regulators. Advocate for Complex Generics development to support the generic pharmaceutical industry and use of USP standards and solutions across the broader scientific and regulatory communities. Maintain awareness of the current trends and issues in the industry by attending scientific seminars, conferences, industry consortia meetings, and other fora. Represent USP science and standards at industry conferences and symposia as well as through written articles. Lead internal and external Complex Generics and Complex Excipient capability-building activities, including training, education, and knowledge-sharing across the organization. Assist in the activities of the USP Expert Committees and Expert Panels, as needed. Communicate and collaborate with USP laboratories regarding projects related to validation studies, method development, and reference standards. Perform other related duties as required.     Qualification & Experience Ph.D. degree in Organic, Analytical, Pharmaceutical/Formulation, or a related field and a minimum of 7-10 years, or M.Sc./M. Pharm with a minimum of 11-13 years of relevant experience with USP-NF test and standards required. Minimum of 5 years of experience with Complex generic formulation development and analytical testing (Injectables, ophthalmic, topical, or transdermal, Inhalation, and other complex formulations) working in the pharmaceutical industry. Specific expertise dealing with complex excipients including polymeric excipients.  

Responsibilities The incumbent is responsible for developing and revising quality standards for dietary ingredients/supplements and responding to internal and external queries related to dietary supplements in USP-NF. These activities require the critical evaluation of relevant scientific documents and other information, the performance of literature searches on related topics, and the development and drafting of pertinent documents for other scientific staff and/or Expert Committee review. The incumbent liaises with expert committee members in the critical review of analytical validation data, and other regulatory and laboratory data to assess suitability of proposed methods and reference standards. The incumbent provides technical input to other DSHM scientists. The incumbent recognizes when additional expertise is needed and he/she has the ability to put together and manage advisory panels. The incumbent also closely follows the work in areas of pharmacopeial standards other than dietary supplements so that collaboration and exchange of information is seamlessly accomplished and made available when needed. He/she establishes and maintains relevant contacts outside of USP, stays abreast of new findings, and informs other scientific staff of new developments in dietary supplement quality methodologies. The incumbent may act as a liaison between Expert Committee and interested parties from government, academia and industry on issues pertaining to standards for dietary supplements.    

Resposibilities Co-lead and manage, together with a Product Operations Manager (POM) and a Technology Lead, a complex, globally deployed, high-impact scientific software product in a GxP environment strive for excellence in product management to continuously improve the impact and value of software and data to BR ensure your product contributes to an intentional, integrated, and capability-based software product architecture and continuously increases the value defined by the strategic mandate of your Product Line ensure adherence to Novartis global Information Security and Quality standards and policies for all products/services ensure regulatory compliance (e.g. GLP & GCP) standards and policies for GxP products/services is adhered   Qualification & Experience Bachelor's degree or equivalent experience in a life science, computer science, engineering or information technology discipline. 15+ years experience in managing software products in a lifescience environment (ideally pharmaceutical research) PhD in a life sciences discipline, scientific informatics or equivalent experience At least 5 years experience in people leadership