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Position: Emerging Market Regulatory CMC Specialist
Location: BKC Building, Mumbai, Maharashtra, India
Primary Job Function :
This is a newly created position to support CMC activities for local and regional products within the Emerging Markets (EM) to ensure activities are completed consistently in a timely manner in accordance with Abbott’s policies, procedures and local regulations.
The overall scope consists of providing CMC support to Regional and Affiliate Product Leads, primarily in:
1. CMC writing for Local and Regional products
- Drafts scientific CMC, and regulatory documents that conform to regional/local/global regulatory requirements, industry standards, and accepted templates.
- Extracts and summarizes scientific information from development reports and identify details required for regulatory submissions.
- Prepares coordinates and manages the review and approval of documents by:
- Supporting the operation of the integrated review process
- Performing comment reconciliation to address and resolve issues
- Editing and creating updated drafts for the next phase of review in accordance with the established timelines
- Complies with Abbott’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of Abbott
2. Relationships & Cross-Functional teamwork
- Compiles and approves regulatory documents in collaboration with technical and operational stakeholders
- Manages review and approval of regulatory documents; engages members of relevant stakeholders to address and resolve issues in accordance with established timelines.
- Monitors and communicates actual versus planned regulatory activities and timelines
- Identifies and communicates risks and issues impacting project progression
- Maintains awareness of regulatory legislation and assesses its regional impact on business and Emerging Market Regulatory Affairs
- Builds and maintains strong working relationships with Regional and Affiliate Product Leads
- Provides accurate feedback to colleagues
- Ensures continuous compliance in alignment with Abbott procedures and regulations
- Maintains awareness of legislation and implement changes as relevant
- Ensure compliance with record retention (archiving) policy
- Takes steps to identify, communicate, and mitigate Regulatory CMC risks
6. Process Improvement
- Supports in streamlining and harmonizing relevant processes
- Creates SOPs delivers training as applicable
- Identifies opportunities and suggestions for continuous improvements
- Demonstrates technical knowledge and a good understanding of systems and tools
- Shows general understanding of regulatory requirements
- Delivers high-quality results
- Meets agreed with deadlines
- Displays consistency
- Shows flexibility and ability to work under pressure
- Reacts quickly to solve problems and issues when they arise
- Manages priorities and align with the manager in case of conflicts/priorities
- Attempts to anticipate, mitigate issues, and proactively flag risks
- Shows problem-solving skills
- Seeks for performance continuous improvements
- Bachelor’s Degree in pharmacy, biology, chemistry, pharmacology, or related subject
- Minimum 2 – 4 years of relevant experience in regulatory operations
- Detailed oriented, communication, compliance, and process improvement skills.
- Computer Knowledge: Knowledge of the Office package (MS. Word, MS. Excel, MS PowerPoint)
Qualification: B.Pharma/Lifescience with Diploma in Regulatory Affairs(Preferable)
Experience: 5- 7 years of relevant work experience
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