hireejobs
Register for Job
Hyderabad Jobs
Banglore Jobs
Chennai Jobs
Delhi Jobs
Ahmedabad Jobs
Mumbai Jobs
Pune Jobs
Vijayawada Jobs
Gurgaon Jobs
Noida Jobs
Oil & Gas Jobs
Banking Jobs
Construction Jobs
Top Management Jobs
IT - Software Jobs
Medical Healthcare Jobs
Purchase / Logistics Jobs
Sales
Ajax Jobs
Designing Jobs
ASP .NET Jobs
Java Jobs
MySQL Jobs
Sap hr Jobs
Software Testing Jobs
Html Jobs
IT Jobs
Logistics Jobs
Customer Service Jobs
Airport Jobs
Banking Jobs
Driver Jobs
Part Time Jobs
Civil Engineering Jobs
Accountant Jobs
Safety Officer Jobs
Nursing Jobs
Civil Engineering Jobs
Hospitality Jobs
Part Time Jobs
Security Jobs
Finance Jobs
Marketing Jobs
Shipping Jobs
Real Estate Jobs
Telecom Jobs

Emerging Market Regulatory CMC Specialist

5.00 to 10.00 Years   Mumbai City   17 Nov, 2020
Abbott Healthcare
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryRetail
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

Primary Job FunctionThis 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.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 team work
  • Compiles and approves regulatory documents in collaboration with technical and operational stakeholders
  • Manages review and approval 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
3. Coordination
  • Builds and maintains strong working relationships with Regional and Affiliate Product Leads
  • Provides accurate feedback to colleagues
4. Compliance across Life-Cycle
  • Ensures continuous compliance in alignment with Abbott procedures and regulations
  • Maintains awareness of legislation and implement changes as relevant
  • Ensure compliance with records retention (archiving) policy
5. Strategy
  • Takes steps to identify, communicate, and mitigate Regulatory CMC risks
6. Process Improvement
  • Support in streamlining and harmonizing operational related processes,
  • Creates SOP delivers training as applicable.
  • Identifies opportunities and suggestions for continuous improvements
CORE COMPETENCIESTechnical
  • Demonstrates general knowledge of technical/scientific principles and some specific knowledge of allocated products
  • Shows general knowledge of global and regional regulatory requirements
Adaptability
  • Shows flexibility and ability to work under pressure
  • Reacts quickly to solve problems and issues when they arise
  • Manages priorities and align with manager in case of conflicts/priorities
Integrity
  • Delivers high quality results.
  • Meets agreed deadlines.
  • Displays consistency
Initiative
  • Attempts to anticipate, mitigate and avoid problems and issues
  • Seeks feedback from manager and team members and adapts behaviour to improve performance
Innovation
  • Develop an intrapreneurial mindset to identify new or unique ways to address work problems or opportunities
Education/Qualifications/Experience
  • Bachelors Degree in pharmacy, biology, chemistry, pharmacology, or related subject
  • A relevant master s degree is preferred
  • Minimum 5 - 10 years of relevant experience in CMC activities
  • Knowledge of Global regulatory procedures, CTD guidelines policies and standards
  • Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
  • Detailed oriented, communication, compliance and process Improvement skills.
  • Computer Knowledge: Knowledge of the Office package (Ms Word, Ms Excel, Ms Power Point)
,

Keyskills :
office packageemerging marketsprocess improvementbusiness requirementslegislative relationsregulatory requirementsctdsopwordexcelstepswritingbiologyrecordscmc

APPLY NOW

Emerging Market Regulatory CMC Specialist Related Jobs

© 2019 Hireejobs All Rights Reserved