Roles and Responsiblities Accountable for the overall RA CMC regulatory strategy in alignment with Product supplies and other key stakeholders,represent RA function in RA matrix team, ensuring alignment of planning and strategy across areas Facilitate dialogues between our project teams and health authorities around the globe with focus on our existing/innovative CMC aiming to provide medicinal products with not just high quality, efficacy and safety, but also with best patient's usability,able to balance LoB and Core team/GPT member responsibility (as and when needed) and ensure timely delivery of tasks Communicate project direction to Novo Nordisk governance in collaboration and agreement with PVP/CPVP,excellent communication skills required including communication and presentation of ambiguous and complex data along with ability to provide convincing arguments within subject matter expert area across the functional area Define best in class regulatory CMC strategies for biopharmaceuticals/combination product thereby ensuring fast submissions and approvals globally,add value by identifying and developing better practice and creating improvements in methods, processes and approaches related to regulatory documentation and strategies Contribute in regulatory intelligence signals analyses for regulated and semi/non regulated markets, exploring differentiated regulatory pathways like reliance pathways, ICHQ12, for securing faster approvals and down classification of change category,Strong Stakeholder management.     Qualifications 15+ years of overall regulatory CMC experience out of which minimum 2-5 years in strategic CMC role and/or CMC lead position Graduate/Postgraduate degree in Life-Science/ Chemistry/ Pharmacy/ Medicine. Experience of working both in Global & Affiliate environment will be preferred. Interaction with European medicines agencies, US FDA and other key agencies. Good understanding of end-to-end Regulatory processes and Life Cycle Management. Highly proactive and able to take initiatives & manage multiple priorities. Self-managed, strong personal drive and ability to engage with colleagues and peers towards delivering excellent performance and results. Excellent written/spoken communication skills. Proven track records of excellent project management, Strong negotiations, influencing and leadership skills Proficient in RA process and IT systems (Veeva Vault)  

Roles and Responsiblities Prospect and identify customer cohorts for targeted engagement. Collaborate with cross-functional teams to establish the Obesity Clinic Program, improving managed care settings for obesity across India. Build partnerships and collaborations with healthcare professionals in private, corporate, and aesthetic centers, as well as nutritionists, to enhance obesity care. Lead and implement patient awareness initiatives, such as camps and HCP-PwO interactions, to raise awareness about obesity as a chronic disease.   Qualifications Life Sciences, Science graduate or equivalent. Bachelors/Diploma in Nutrition / Hospital management. Desired Business administration. 5 -8 years of field experience in Launch sales responsibility, Market/therapy shaping pre-launch. Partnership establishment and continued development. Development of Centre of Excellence/On-ground activation.  

Roles and Responsiblities Drive compliance support to International Operations (IO) and North America Operations (NAO) & Support Deviation, validation, and CR handling set-up fit for purpose in IO and NAO. Be the subject matter expert for Deviation, CR handling, and Cold chain equipment Qualification. Analyze data of Deviations and Change Requests handled by the team and identify meaningful trends, Drive process efficiency projects based on identified trends. Responsible for data analysis of Deviations in Operations and handled by the team and for identifying and driving improvement projects within Deviations, cold chain validation, CR handling, and other relevant processes. Derive KPIs for the QMS and measure performance and put in place improvements and maintain specialist knowledge and awareness related to delivery areas assigned.     Qualifications University/equivalent degree (Engineering, Pharmacy, Biology, Chemistry, or similar) Overall, 9-12 years of experience, Mpharm/MSc: and 7+ years of relevant experience, Bpharm/BSc: and 9+ years of relevant experience Trained and worked according to international validation principles. Experience with Change Request handling Worked within cLEAN/LEAN projects. cLEAN certified. Leadership experience. Experience with GMP/GDP on operational level  

Roles and Responsiblities   To manage the EMSO Quality system requirements in accordance with Teva quality standards and in compliance with the regulatory requirement such as Responsible to follow the Quality Management System of EMSO organization, which is relevant to job function, Management of NTM/ GNTM, Training Management, CAPA management., Global Projects Monitoring, Document Management, Quality Management System. Ensure storage and retention of the GMP documentation as per the defined retention period. Ensure timely completion of impact assessment and risk assessment related to NTM/GNTM and participate in QAM / CVI meetings. Provide timely decisions to SRT and CMOs for issues related to NTM/ GNTMs. KPI Metrics management for EMSO Quality and ensure no overdue Change controls, Deviations and CAPAs. Monitoring Change Control Board for EMSO APAC KPI metrics management associated with CMOs supplying products to EMSO through monthly dashboards. Ensure completion of CMO risk assessments as per defined frequency. Responsible for data analysis and compilation to report in Monthly Dashboards, Quality Councils, Quality Business Reviews and any other applicable review meetings. Ensure timely completion of CAPAs and no overdue CAPAs. Responsible for providing timely responses to the audit observations for the audits conducted at EMSO APAC. Responsible for implementation of CAPAs related to any audit observations. Responsible for preparing and monitoring self-inspection schedule and conducting self-inspection as per the schedule at EMSO Quality APAC. To approve Complaint investigations, Deviations, Change controls and extensions related to these records   Qualifications Minimum 10-15 years of experience in pharmaceutical industry Knowledge of cGMP, Quality management Systems and the pharmaceutical manufacturing, supply chain environment Knowledge on Compliance Standards and Regulation as applicable to the market. Experience of handling Operational Quality, QA/QC exposure and External / Contract manufacturing sites. Knowledge and working experience with USFDA / EU and other competent authority approved sites. M. Pharm / M.Sc.

Roles and Responsiblities Compiling and reviewing of the Annual Report and ensuring it is submitted prior to the commitment date (at minimum no later than the due date). Assessing, reviewing and approving the change controls initiate by manufacturing sites. Compilation and submission of post approval supplements (CBE 0, CBE 30, PAS) in US. Coordinating the retrieval of supporting documentation in accordance with the Annual Report schedule. Retaining all supporting documentation as required in completing an Annual Report. Notifying Regulatory Affairs Manager or designee (and Quality, if required) that an Annual Report is at risk of being submitted late.     Qualification and Experience Degree in science/life science/pharmacy or equivalent qualification(s) Five to Six year experience in the Pharmaceutical Industry, ideally within Regulatory Affairs but R&D, Development or QA would be considered. Desirable to have experience with preparation and compilation of Annual reports. Handling of change controls and process. Experience and through knowledge in assessing and filing of US post approval supplements.    

Roles and Responsiblities   Developing an understanding of regulations, guidelines, procedures and policies. relating to registration and manufacturing of pharmaceutical products. With management oversight, ensuring data and information packages are fit for purpose. Beginning to understand internal/external CMC Regulatory environment. Begin to build organisational networks. Regular communication with line manager to help identify any CMC issues with business impact. Conducts routine Rx and/or Vx CMC projects with support

Roles and Responsiblities Ensure compliance to regulatory requirements on product, process, equipment and release procedures. Manage Batch certification activities related to commercial dispatch in a timely manner. Escalate compliance concern to concern stakeholder. Review, compliance of BPR and batch release for commercial dispatch. Review and approve all deviations and OOS/OOT investigations Execute change control and risk assessment whenever required. Ensure Quality Metrics are reported as per specify timeline. Planning and arranging for internal and external departmental support of Quality Assurance activities as directed in approved protocols, quality systems or Procedures. Follow the EHS policy, laboratory standard operating procedures and maintain the compliance to GMP requirements.   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"

Roles and Responsiblities   Identify, assess, and oversee compliance with legal requirements related to Environment, Health, and Safety (EHS) for API sites. Ensure efficient functioning of Zero Liquid Discharge (ZLD) systems and effluent treatment plants across API sites Provide guidance to sites for the adoption of global Environmental, Health, and Safety (EHS) standards, including interim actions.  Create operational and capital budgets for environmental expenses across sites, and monitor their implementation Coordinate and schedule regular meetings with stakeholders to discuss various aspects of the environment management system and safety management system Ensure adherence to ISO 14001 and ISO 45001 compliance requirements, including third-party audits Facilitate comprehensive Process Hazard Analysis (PHA) or HAZOP studies for all processes, ensuring the implementation of hazard study outcomes to enhance process safety Provide strategic guidance and mentorship to the team, fostering their professional development and enhancing their competencies Engage actively in accident and incident investigations, ensuring that corrective and preventive actions (CAPA) are promptly implement.  Create a strategic roadmap to enhance the existing Environmental, Health, and Safety (EHS) and sustainability management system, aligning it with relevant legal requirements, regulations, and international standards. Facilitate ongoing enhancement by assessing performance and delivering constructive feedback to management. Oversee EHS and sustainability compliance activities to ensure the efficient implementation of the EHS management system, policies, procedures, and programs throughout the organization. Continuously assess and review existing, new, and upcoming EHS legislation, rules, and regulations. Ensure that robust systems and procedures are in place to meet compliance and other requirements. Evaluate and enhance all facets of EHS policies and activities, ensuring consistent implementation across all projects Collaborate proactively with Project and Engineering Heads, as well as other key employees, to develop and sustain a program focused on continuous improvement within their respective areas of responsibility for Environmental, Health, and Safety (EHS) management. Establishing a comprehensive training and capability development system, which involves providing training, guidance, and coaching to the site EHS team to enhance their technical proficiency in Environmental, Health, and Safety (EHS) practices. Provide assistance and support to the site EHS team during presentations or meetings with regulatory authorities, as needed To ensure effective communication and alignment, regularly convene review meetings with the EHS teams across all sites. These meetings can be conducted through periodic site visits as well as teleconferences. During these sessions, discuss progress, address challenges, and strategize for continuous improvement in Environmental, Health, and Safety (EHS) practices Collaborate closely with the site EHS team to verify and uphold EHS regulatory compliance at each site. Additionally, provide guidance and assistance to the site team whenever necessary to enhance their compliance efforts Foster EHS awareness by establishing a competitive environment among sites. Regularly review and score each site based on their EHS performance using a culture meter score. Recognize and reward top performers to encourage continuous improvement.   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"

Roles and Responsiblities Actively engage with R&D and act as the Stage Gate for products at the Engineering Batch and Submission stage of new product introductions. Create, promote and improve business and technical processes. Drive global standards for validation and product robustness across all the regions. Develop and implement a knowledge data base system to ensure that technical transfer activities are executed and summarized with appropriate results in approved reports to support regulatory filings and tech transfers. Should have knowledge of Product development expertise using QbD principles and expertise in evaluating the relationships between CPP and CQAs.  Expertise and skills to oversee Structured Root cause investigations and commercial trouble shooting including ensuring a right process is followed and CAPA identified.  Establish process monitoring and improvements at commercial manufacturing facilities and at Contract Manufacturing Organizations (CMOs) using scientific/technical concepts and techniques in collaboration with Site Technical leaders. Review and approve proposals for improved manufacturing processes, implementation of PAT and other tools that enhance process robustness and state of process and product knowledge. Skills in product scale changes and suggesting manufacturing modifications if required with a full 360 deg impact assessment to ensure faster and smoother implementation Deliver agreed financial targets such as departmental budget and key performance indicators   To coordinate with different departments i.e. Formulation Development, Production, Project Management, Quality Control, Quality Assurance, Packaging for the timely execution of the New projects (Exhibit batches) for solid dosage plants in India.  To oversee manufacturing of trial /scale up & exhibit batches, pre –launch/Characterisation batches & process validation batches for US, Europe, Canada, emerging and India market To arrange for the readiness of the New Product Launch at solid dosage plants in India To review & respond for process related regulatory query for exhibit batches. To review Justification/Investigation/Technical report for any event/incidence observed during the execution of the Exhibit batches. To investigate and support operation to resolve the Trouble shooting projects for solid dosage plants in India. To review Life cycle management projects like batch size increase, solvent reduction etc and provide technical support to Operation for implementation of same. To review site transfer documents and identify Gaps and support technical part to operation. To support operation and quality for alternate vendor qualification as per Global & site SOP. Identify and improve product robustness in collaboration with QA and production. To conduct weekly, Monthly and quarterly review meeting with all MSTG leads and key team members of all solid manufacturing plants in India. To conduct Monthly team huddle meeting with entire MSTG team of solid oral To participate in various regulatory audits to support plant. To contribute in Team building by imparting Training to teammates to upgrade capability Identification and evaluation of new technologies that can make SPIL competitive in manufacturing.   Qualifications Advanced degree in pharmaceutics or science or engineering with minimum 15 years’ experience in the pharmaceutical drug product industry is preferred; Ph.D. or other advanced degree with comparable industry experience is desired.   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"

Responsibilities In the Preparation and review of ANDA for US Submission for oral solid dosage form (Tablet & Capsule) /Parenteral formulation. Should have knowledge of eCTD format for US/Europe and other regulatory agencies. Responding to the ANDA deficiency. Review of CMC section of drug substance for ANDA submission. Submission of Post-approval changes (viz. PAS, CBE-0, CBE-30). Review of Bioequivalence study protocol and report. Submission of Annual report/PADER to FDA. Knowledge in eCTD software & also have knowledge of DMF.