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Job Location | Hyderabad |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Medical / Healthcare |
Functional Area | General / Other Software |
EmploymentType | Full-time |
271199BRGroup Lead - IM&SJob DescriptionYour Responsibilities: Your responsibilities include, but not limited to: Take leadership and ensure that the deliverables are provided in high quality, in compliance with Health Authority requirements and according to given timelines Act as the main contact during the submission preparation and execution phase of product development and initial submission projects. Receive and resolve or mitigate issues. Implement actions to prevent that issues doesn t happen againAct as a service provider for customers in Regulatory and stakeholders outside of Regulatory. Build up a communication network with the stakeholder communityInform IM&S LT about the progress of ongoing activities and provide performance reports on a regular basis Collaborate closely with the RA IM&S TS Head to facilitate a highly performing technical services function within IM&S organization, which supports global Regulatory Affairs at optimal efficiency. Monitor the functional KPIs and targets. Escalate deviations and support appropriate mitigation actions when targets are not on track and follow up on action plan. Select, recruit, develop, manage, coach, coordinate and appraise the performance of reports and ensure high quality performance management across Regulatory IM&S In cooperation with IM&S TS Head and together with the team strive for excellence and support initiatives like knowledge transfer between sites and sub- functions to develop and ensure a globally acting support function Drive top- level talent acquisition, succession planning and development of all associates within the department Actively coach and partner with direct reports to build and implement their development plans. Systematically sets clear expectations and fosters mutual collaboration, transparency, integrated alignment and quality of interactions as a desired operating behavioral modelConsistently applies adequate consequence management to incentivize and recognize positive contributions. Ensure an optimized organization structure to support continuous improvement and efficiency and ensure alignment of operations with other departments and organizational entities. Why consider SandozOur number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA- cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever- more digital and global worldThe answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks. Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics. Join us, and help reimagine access to medicine. Minimum requirementsWhat you ll bring to the role: 1. Masters Degree in Science or Pharmacy with Minimum 5 8 years experience in leadership 12+ experience in regulatory affairs, experience in Regulatory Operations is an advantage2. Long- term experience in leadership 3. Long- term experience in regulatory affairs 4. Strong project management skills 5. Strong negotiation skills Well- structured, result- oriented, highly self- committed, resilient, flexible, team player6. Active command in English with excellent written and spoken communication skills 7. Good knowledge of Regulatory toolsDivisionSANDOZ Business UnitProduct Dev SZ CountryIndia Work LocationHyderabad, AP Company/ Legal EntityNov Hltcr Shared Services IndFunctional AreaResearch & Development Job TypeFull TimeEmployment TypeRegular,
Keyskills :
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