Manager Regulatory Affairs, CMC Biosimilar job opportunity at Abbott.

Home Jobs In India Tag: CMC Biosimilar Manager Regulatory Affairs, CMC Biosimilar position at Abbott


DatePosted 30+ Days Ago bot
Abbott Manager Regulatory Affairs, CMC Biosimilar
Experience: 10-years
Pattern: full-time
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CMC Biosimilar

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degreeMBA
loacation India - Mumbai, India
loacation India - Mumbai....India

      JOB DESCRIPTION: Primary Job Function: With Manager Support:- 1. Product registrations / Submissions -Actively leads product registrations by preparing/ requesting documentation needed for complex filings -Employs project management skills to monitor activities and meet deadlines -Prepares registration packages for routine filings -Identifies and collects data needed -Seeks expert advice and technical support for complex filings -Prepares responses to deficiency letters 2. Relationships & Cross Functional team work -Represents Regulatory CMC at relevant project meetings and communicates agreed RA position -Monitors and communicates actual versus planned regulatory activities and timelines -Identifies and communicates risks and issues impacting project progression 3. Affiliate Coordination -Maintains strong working relationships with Regional Product Leads and Affiliate colleagues 4. Compliance across Life-Cycle -Assesses and approves change requests and updates files accordingly -Maintains awareness of legislation and current developments within specific area of business -Works to assure products remain in compliance 5. Strategy -Develops Regulatory CMC strategies for assigned biosimilar/ biologics products and projects -Identifies, communicates, and mitigates Regulatory CMC risks 6. Process Improvement -Identifies opportunities and suggests improvements -Supports the development of position papers & work aids etc 7 . Health Agency Interaction -Attends Health Agency meetings as appropriate 8. Licensing Reviews -Provides CMC Regulatory support for due diligence activities 9. Technical competency -Has general knowledge of technical/scientific principles and develops specific knowledge of allocated products -Has general knowledge of global and regional regulatory requirements -Has specialist regulatory knowledge of assigned country or product-class requirements CORE COMPETENCIES Adaptability -Effectively prioritizes mid-term (weeks) to longer-term (months) work tasks -Regularly reviews commitments and re-prioritises activities or negotiates timelines as necessary -Reacts quickly to solve problems and issues when they arise Initiative -Starts to learn new aspects of the business and understand the roles of other functions -Proactively anticipates, mitigates and avoids problems and issues -Proactively seeks feedback from manager and team members and adapts behaviour to improve performance Innovation -Has 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 -Actively interacts with colleagues to drive completion of team and shared goals LEADERSHIP COMPETENCIES Set Vision and Strategy -Clearly articulates Regulatory CMC strategies and obtains alignment and agreement from key stakeholders Build Organization and Inspire People -Mentors junior team members -Provides training and support on areas of subject matter expertise -Proactively strengthens own leadership skills and actively uses these skills in day to day work Drive Results -Encourages others to complete goals Make Difficult Decisions -Interacts with cross-functional and department colleagues to help drive efficient decision-making Encourage an Open Environment and Knowledge Sharing -Provides honest, accurate feedback to managers, whether positive or negative -Not afraid to challenge peers and managers and be challenged -Openly shares information with peers A minimum of 10 years of experience in Biosimilar Global Regulatory Affairs. Proven exposure to US and EU regulatory environment. Experience in emerging markets/ rest of world will be considered an added advantage.       The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.       JOB FAMILY: Regulatory Operations       DIVISION: EPD Established Pharma          LOCATION: India > Mumbai : Mumbai Development Center - EPD       ADDITIONAL LOCATIONS:       WORK SHIFT: Standard       TRAVEL: Not specified       MEDICAL SURVEILLANCE: Not Applicable       SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)                  

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