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Job Location | Mumbai City |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Education / Training |
Functional Area | Sales / BD |
EmploymentType | Full-time |
Job Opening Details back to list Reference Code: SeniorExe0321Mumbai Job Title: Regulatory Affairs Manager/ Senior Executive (remote working)* Category: Pharmaceuticals, Hospitals / CRO, Bio Technology & Life Science About company:Fast-growing Pharma company having its offices in India, UK, Australia, Middle East & Europe*Job title: Regulatory Affairs Manager/ Senior Executive (remote working)**Job location: Mumbai*Educational qualification: Bachelor s degree is required. Scientific/health field with relevant work experience.Experience :- Generally, has at least 5 to 8 years of related experience within a pharmaceutical company, CRO, CMO or similar organization. The regulatory experience should be broad as a generalist regulatory professional Must be able to communicate comfortably and effectively with regulatory authorities. Must be able to independently present complex global regulatory strategies internally and to Atnah s partners. Strong knowledge of EU regulatory framework and guidelines. Awareness of emerging markets submission rollouts Expertise in regulatory submission structure and content (e.g. MAA, NDA) Experience in compliance and maintaining product life cycle data bases and RIMs systems Ability to work successfully within a cross-functional team. Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines. Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands. Expertise to write scientific and technical documents Generally, has at least 5 years of related experience within a pharmaceutical company, CRO, CMO or similar organization. The regulatory experience should be broad as a generalist regulatory professionalSkills :- Proven ability to independently resolve problems. Strong knowledge of MS Word, Excel, PowerPoint, Project and Outlook. Global regulatory strategy and deployment decisions; defining strategic priorities Ability to work independently, take initiative and complete tasks to deadlines. Fluent Italian or FrenchCTC : (depends on current CTC, relevant work experience & qualification) Key Skills: Fluent Italian or French, MS Word, Excel, PowerPoint, Project and Outlook. Location: Mumbai Required Experience: 5-8 yrs Positions: 1 Contact Person: Hitesh Vaghela Email ID: db@tercpl.com Qualification: Any Graduate,
Keyskills :
establishing prioritieslife cyclecroregulatory affairsdeliveryemerging marketscustomer relationsmissalesproduct life cyclecustomer servicemaactc