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Position: Asst Manager – Regulatory Affairs
Location: BKC Building, Mumbai, Maharashtra, India
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 a specific areas 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
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
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 the 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
Qualification: B.Pharma/Lifescience with Diploma in Regulatory Affairs(Preferable)
Experience: 5- 7 years of relevant work experience
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