15h Left) Opening For Asst Manager Global Regulatory Affairs Cmc In For Hospitals

Designation Asst Manager Global Regulatory Affairs CMC On a Contract Department Global Regulatory Affairs CMC Contract Duration 12 Months will be working on Talisman payroll Not renewable Location MIDC Andheri East Mumbai Working Day Monday To Friday Time 9 A M To 6 P M Primary Job Function 1 Product registrations Submissions -Assists in product registrations by preparing requesting documentation needed for filings -Prepares registration packages for routine filings -Identifies and collects data needed -Prepares responses to deficiency letters 2 Relationships Cross Functional team work -May represent Regulatory CMC at relevant project meetings and communicates agreed RA position -Monitors and communicates actual versus planned regulatory activities and timelines 3 Affiliate Coordination -Works with Regional Product Leads and Affiliate colleagues 4 Compliance across Life-Cycle -Assesses change requests and updates files accordingly -Builds awareness of legislation and current developments within specific area of business -Works to assure products remain in compliance 5 Strategy -Provides input into the generation of Regulatory CMC strategies for assigned products and projects -Works with manager to identify communicate and mitigate Regulatory CMC risks 6 Process Improvement -Identifies opportunities and suggests improvements -Collects information to support the development of position papers work aids etc 7 Health Agency Interaction -Helps to prepare for Health Agency meetings as appropriate 8 Licensing Reviews -Can provide CMC Regulatory support for due diligence activities 9 Technical competency -Has general knowledge of technical scientific principles -Has general knowledge of global and regional regulatory requirements CORE COMPETENCIES Adaptability -Works with manager to prioritize short-term days work tasks -Works with manager to regularly review work commitments and activities -Reacts quickly to solve problems and issues when they arise CORE COMPETENCIES Adaptability -Works with manager to prioritize short-term days work tasks -Works with manager to regularly review work commitments and activities -Reacts quickly to solve problems and issues when they arise Initiative -Attempts to anticipate mitigate and avoid problems and issues -Seeks feedback from manager and team members and adapts behaviour to improve performance Innovation -Starts to develop an intrapreneurial mindset to identify new or unique ways to address work problems or opportunities Integrity -Delivers high quality results -Meets agreed deadlines -Exhibits honesty and presents complete impartial information -Displays consistency between words and actions -Acknowledges and responds constructively to failures and mistakes -Expresses dissatisfaction constructively without over-reacting Teamwork -Interacts with colleagues to complete team and shared goals LEADERSHIP COMPETENCIES Set Vision and Strategy -Contributes to generation of robust Regulatory CMC strategies supporting right-first-time submissions Build Organization and Inspire People -Shares knowledge and previous experience with peers Drive Results -Completes goals according to agreed deadlines Make Difficult Decisions -Provides information to help with decision-making within scope of project product responsibilities Encourage an Open Environment and Knowledge Sharing -Provides honest accurate feedback to colleagues whether positive or negative -Not afraid to challenge peers and be challenged -Openly shares information with peers Supervisory Management Responsibilities Direct Reports None individual contributor Indirect Reports None individual contributor Minimum Education Bachelor s Degree in pharmacy biology chemistry pharmacology or related subject Minimum Experience Training Required A minimum of 10 years of experience in Global Regulatory Affairs for Emerging markets Except US and Europe