Anu Antony
Copenhagen
Summary
Dynamic Global RA CMC Professional with a proven track record at AJ Vaccines, excelling in CMC dossier preparation and regulatory compliance. Expert in CGMP and ICH guidelines, I enhance process efficiency while fostering cross-functional collaboration. My commitment to quality control and effective communication drives successful submissions in global markets.
Overview
18
18
years of professional experience
Work History
Global RA CMC Professional
AJ Vaccines
Copenhagen
07.2020 - Current
- CMC Dossier Preparation & Submissions: Leading the preparation, review, and submission of high-quality regulatory documents for global markets, including Module 3 (Quality) of the Common Technical Document (CTD)
- Regulatory Compliance: Ensuring alignment with international regulatory guidelines (e.g., EMA, WHO) for vaccines and biopharmaceutical products
- Cross-Functional Collaboration: Partnering with R&D, Quality, and Manufacturing teams to gather critical data and address regulatory requirements effectively
- Process Improvement: Streamlining regulatory processes to enhance efficiency and reduce submission timelines
- Technical Expertise: Leveraging a solid scientific background to bridge the gap between technical teams and regulatory authorities, ensuring accurate representation of data in submissions
Quality Control Academic
AJ Vaccines
Copenhagen
07.2017 - 06.2020
- Preparation of various stability study protocols and reports on the API/FPP products, Process and quality control of drug products in collaboration with other QC units, production department and QA
- Preparation and maintenance of instructions, specifications and analysis regulations, and associated analysis journals
- Experience in cGMP, GLP, FDA and ICH guidelines; Compose, review and document standard stability testing protocols/reports for API's and FPP in defined documentation/computer systems
- Ensuring GMP in the analysis work after completion of relevant analyses, Preparation of deviation reports, CR and CC
Airline Attendant
Air India Charters Limited
01.2007 - 01.2013
- As a purser and flight in-charge with Air India, I was responsible for:
- Assuring safety and security on-board
- Briefing crew on standard operating procedures
- Continued certification as first aider
- Crisis and emergency management
- Team and service management
- Customer service delivery
Education
Master of Science (MSc) - Marine Biology
Cochin University of Science and Technology
01.2006
Bachelor of Science (B.Sc.) - Zoology
St. Teresa's College
Ernakulam01.2004
Secondary school certificate - Pure Sciences
Nava Nirman Public School
Cochin01.2000
Primary School Certificate -
Toc H Public School
Cochin01.1998
Skills
- CGMP
- GLP
- ICH Compliance
- Deviation Management
- CR Preparation
- CC Preparation
- Process Control
- Quality Control
- APIs
- FPPs
Languages
- Tamil, Limited Working
- Danish, Limited Working
- English, Full Professional
- Malayalam, Native or Bilingual
- Hindi, Native or Bilingual
Personal Information
Title: Global RA CMC Professional at AJ Vaccines
Timeline
Global RA CMC Professional
AJ Vaccines
07.2020 - Current
Quality Control Academic
AJ Vaccines
07.2017 - 06.2020
Airline Attendant
Air India Charters Limited
01.2007 - 01.2013
Master of Science (MSc) - Marine Biology
Cochin University of Science and Technology
Bachelor of Science (B.Sc.) - Zoology
St. Teresa's College
Secondary school certificate - Pure Sciences
Nava Nirman Public School
Primary School Certificate -
Toc H Public School
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