Description

<h2>JOB DESCRIPTION:</h2><div><div><div><div><div><div><div><div><div><div>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 letters2. 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 progression3. Affiliate Coordination-Maintains strong working relationships with Regional Product Leads and Affiliate colleagues4. 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 compliance5. Strategy-Develops Regulatory CMC strategies for assigned biosimilar/ biologics products and projects-Identifies, communicates, and mitigates Regulatory CMC risks6. Process Improvement-Identifies opportunities and suggests improvements-Supports the development of position papers & work aids etc</div></div></div></div></div></div></div></div></div></div><div><div><div><div><div><div><div><div><div><div><div>7. Health Agency Interaction-Attends Health Agency meetings as appropriate8. Licensing Reviews-Provides CMC Regulatory support for due diligence activities9. 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</div></div></div></div></div></div></div></div></div></div></div>CORE COMPETENCIESAdaptability-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 ariseInitiative-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 performanceInnovation-Has an intrapreneurial mindset to identify new or unique ways to address work problems or opportunitiesIntegrity-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 goalsLEADERSHIP COMPETENCIESSet Vision and Strategy-Clearly articulates Regulatory CMC strategies and obtains alignment and agreement from key stakeholdersBuild 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 workDrive Results-Encourages others to complete goalsMake Difficult Decisions-Interacts with cross-functional and department colleagues to help drive efficient decision-makingEncourage 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 peersA 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/AIn specific locations, the pay range may vary from the range posted. <h2>JOB FAMILY:</h2>Regulatory Operations     <h2>DIVISION:</h2>EPD Established Pharma        <h2>LOCATION:</h2>India > Mumbai : Mumbai Development Center - EPD     <h2>ADDITIONAL LOCATIONS:</h2>     <h2>WORK SHIFT:</h2>Standard     <h2>TRAVEL:</h2>Not specified     <h2>MEDICAL SURVEILLANCE:</h2>Not Applicable     <h2>SIGNIFICANT WORK ACTIVITIES:</h2>Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Manager Regulatory Affairs, CMC Biosimilar

Description

Abbott

Pipeline