Responsibilities Maintain a positive collaboration and partnership with internal groups in R&D, Quality and manufacturing Maintain a positive business collaboration and partnership with global regulatory business partners of Elanco Lead CMC submission preparation to provide high quality submissions to multiple geographies Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams Lead and implement all global CMC submission activities for assigned projects/products, while applying the global strategy into submissions. Ensure the required documentation and any content, quality and/or timelines for global submissions are communicated to the appropriate teams and tracked accordingly Author high-quality CMC documentation for submission, applying CMC global regulatory strategies, assuring regulatory compliance. Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends     Experience Up to 5 years in Global Regulatory Affairs, preferably within Post-approval CMC Life Cycle Management.  

Responsibilities Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product – with an end objective to develop medical regulatory content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical regulatory writers in developing knowledge and sharing expertise. Performance: Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT) as per agreed timelines and quality Process: 1) Author, review, act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported. 2) Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis. 3) Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region. 4) Work with selected vendors within the region to deliver the required deliverables as per the defined process. 5) Design an overall plan of action basis end-customers feedback & improve course content and delivery. 6) Prepare/review stand-by statement and questions and answer (SBS QA) document as part of managing Product Alerts. 7) Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness. 8) Remain abreast of Sanofi Policy or Quality Documents evolution. Stakeholders: 1) Work closely with Clinical/Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Proactively liaise with the Clinical/Medical/Pharmacovigilance/Biostats/Regulatory/Legal/Regulatory/Corporate Affairs departments to prepare relevant & customized deliverables.     Qualification & Experience Experience: >5 years of experience in regulatory writing for the pharmaceuticals/healthcare industry Soft skills: Stakeholder management; vendor management; communication skills; and ability to work independently and within a team environment Technical skills: As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, excellent technical (medical) editing and writing skills, data retrieval, interpretation of scientific data, medical literature screening, knowledge of ICH and GCP/GVP, ability to summarize scientific information and edit text for specific audiences, well-versed with computer applications) Education: Advanced degree in life sciences/ pharmacy/ similar discipline (PhD, Masters or bachelor’s in science, D Pharma, PharmD) or medical degree (MBBS, BDS, BAMS, BHMS, MD)  

Responsibilities Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks. Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements/variations, annual reports, registration renewals and responses to health authority questions per established business processes and systems. Liaise with global CMC, Our Manufacturing Division and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance. Assess and communicate potential regulatory risks and propose mitigation strategies. Deliver all regulatory milestones for assigned products across the product lifecycle Identify and communicate potential regulatory issues to GRACS CMC management, as needed     Qualifications & Experience Bachelor of Science, Engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry 0 – 3 yrs of Industry Pharmaceutical industry experience  

Responsibilities Functions as product owner for site transfer submissions for assigned products, working with cross functional team, site team and corporate regulatory team to ensure preparation of quality global regulatory strategy document and supplements / variations. Responsible for the preparation and finalization of Global Regulatory Strategy Documents (GRSD), CTD sections of supplements / variations for site transfer submissions. Also provides guidance and support to Junior Product Owners in the preparation of quality global regulatory strategy document and supplements. Responsible for effective co-ordination with the cross functional teams at site and corporate for the review and finalization of supplements to ensure effective data presentation and quality Responsible for effective review and providing timely feedback to the teams on technical documents related to transfer (Technology transfer protocols), batch documents related to submission (batch records, Exhibit batch and stability protocol, etc.,) Provides regulatory support for Change assessment related to submissions from Vizag site Provides regulatory support to the cross functional teams for the assigned products ,participates and provides inputs in technical reviews and strategic discussions on regulatory submissions Collaborates with and ensures adequate support to the regional team to ensure completion of assigned shared task or goal. Identifies , assesses regulatory risks associated with assigned projects and timely communication of the issues, its impact to global regulatory management & core team and drives resolution of issues Drives resolution of issues. Communicates issues, impact and outcomes to global regulatory management, team lead and core team. Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects Responsible for ensuring compliance to Company’s submission standards, policies and procedures.   Qualification & Experience Bachelors or Master in Science / Pharmacy Minimum 5 to 10 Years in leading independently or a team in the Regulatory Affairs function in a reputed pharmaceutical organization with major experience in handling new submissions  

Responsibilities Collaborate closely with engineering and technology teams to ensure generation of high-quality invention disclosures in the field of AI and call center automations. Coordinate with your manager and offer recommendations on invention disclosures for assisting in filing decisions. Prepare high quality patent applications (about 30 per year) originating from Uniphore’s global locations for filing before the USPTO, European Patent Office, Indian Patent Office, PCT or other jurisdictions. Help preparing responses to Office Actions (OA) globally and prosecute patent applications before the Indian Patent Office (about 20-30 OA and 40-50 hearings per year but may vary). Help stimulate innovation by helping prepare training presentations, attend group discussions with engineering and technology teams to capture innovation, conduct patent landscape analyses; assist with efforts on claim analyses, patenting strategy, freedom to operate, and open-source software, revieing contracts with IP clauses. Ability to review contracts with IP clauses, support in matters relating to infringement, litigation, and licensing, and oversee paralegal work is desirable.     Qualification & Experience Bachelor’s degree or above in science or engineering. Qualified Indian Patent Agent with at least 5 years of post-qualification experience. Demonstrated ability to respond to official actions and attend hearings. Demonstrated ability to perform patentability searches. Proven track record in a reputed law firm or as an in-house counsel in a large multinational or a global Indian company.  

Hiring for graduate and post graduation freshers 2023 batch pass out.   Qualification & Experience B.Sc/M.Sc (Science Stream) 2023 batch Fresher's Good communication skills   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Qualification & Experience Diploma in emergency medical technician 1 to 6 years of experience   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities Ent, Liver Transplant, Plastic     Experience 2 to 5 years   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Qualification & Experience B.sc / M.sc Nuclear Medicine 2 to 5 years of experience   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities The Medical Doctor will be responsible for conducting patient examinations, diagnosing illnesses and injuries, prescribing medications, and developing treatment plans. The Medical Doctor will also be responsible for managing patient records and communicating with other healthcare professionals.   Qualification & Experience Medical degree and valid license to practice medicine Strong knowledge of medical procedures, medications, and treatments Excellent communication and interpersonal skills Ability to work independently and as part of a team Experience in nutraceuticals or preventive medicine is a plus Fluent in English, Marathi and Hindi Willingness to learn and stay current with developments in the field of nutraceuticals and preventive medicine