Data Science
Ana Sharif
Regulatory Affairs
Raipur
Summary
Well-organized and diligent Regulatory Affairs Specialist adept at coordinating and tracking regulatory-related actions. Highly successful at keeping on top of changes in requirements to maintain flawless compliance. Offering nearly 3 years' experience in Pharmaceutical Industry and looking for a challenging new role.
Overview
4
4
years of professional experience
7
7
years of post-secondary education
6
6
Certifications
3
3
Languages
Work History
Regulatory Affairs Officer
Mylan Laboratories Limited
Hyderabad
08.2013 - 05.2016
- Compilation of high quality registration dossiers of Solid Orals. Preparation, reviewing and regulatory submissions in CTD and country specific format to the different Regulatory Agencies.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Represented company finished product for approval, queries and post approval with global regulatory agencies.
- Prepared and maintained document inventory for core dossier preparation.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Assisted with regulatory product compliance initiatives.
- Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products.
- Provided responses to regulatory agencies regarding product information or issues.
- Directed documentation efforts to comply with domestic and international regulations and standards.
- Trained staff in regulatory policies or procedures.
- Managed fees and applications, tracked product progress and handled all responses to regulatory inquiries.
- Consulted with regulatory representatives to manage filings, applications and reports.
- Devised and deployed techniques for obtaining earliest possible approval for each product.
- Managed Post approval activities (i.e. preparation and submission of Site Transfer and Variations) for different projects.
- To co-ordinate with FR&D, API regulatory affairs ADL (Analytical Development Laboratories), Q.A, Q.C, CR (Clinical Research) and Production departments for collection of required data and regular day to day problems and suggestions for the betterment of existing process.
- Working with cross functional team for product development and operational excellence.
- Responsible for maintaining and updation of Registration certificate /information in regulatory data base.
Seminarian
ISPOR, Indian Habitat Center
New Delhi, India
11.2012 - 11.2012
- Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
- Maintained energy and enthusiasm in fast-paced environment.
- Created plans and communicated deadlines to ensure projects were completed on time.
Vice-President
Society of Columbia Institute of Pharmacy
Raipur
07.2009 - 03.2010
- Releases College Magazine named as INSCRIPTION.
Student Editor
Columbia Institute of Pharmacy
Raipur
01.2008 - 01.2009
- In-Chief, in Pharmaceutical Society of, Institute of Pharmacy
- Determined readiness of written pieces, made changes and approved final versions for publication.
- Guided and motivated staff to achieve demanding targets under tight deadlines.
- Edited existing PowerPoint slides to enhance corporate message.
- Maintained professional, friendly and productive relationships with team representatives to stay updated on team strategies, changes and victories.
Education
M.Pharma - Pharmaceutical Sciences
DIPSAR
New Delhi 01.2011 - 03.2013
B.Pharma - Pharmaceutical Sciences
Columbia Institute of Pharmacy
Raipur 08.2007 - 05.2010
D.Pharma - Pharmaceutical Sciences
Jamia Hamdard
New Delhi 08.2005 - 10.2007
Skills
Data verification
Guidelines & SOP Compliance
Time Management
Technical Documentation
Global Regulatory Compliance
Regulatory Policies
Problem-solving skills
Excellent Communication
Critical Thinking
Multitasking Abilities
Dependable and Responsible
Accomplishments
- Used advanced Microsoft Excel to develop Product lifecycle tracking spreadsheets.
- Certified from Kennedy School, Harvard University in “Excersing Leadership: Foundational Principles”.
- Certified from IBM in SQL for Data Science.
- Certified from Louvain School of Management, Belgium in Supply Chain Management: A Decision Making Framework.
- Certified from IBM in Introduction to Data Science.
- Certified from IBM in The Data Science Method.
Certification
SQL for Data Science by IBM
Interests
Data Visualization
MS Excel with advanced formula
Timeline
SQL for Data Science by IBM
06-2021
COVID-19 Training for Healthcare workers by Stanford University
06-2021
Excersing Leadership: Foundational Principles By Harvard University
05-2021
The Data Science Method by IBM
08-2020
Introduction to Data Science by IBM
07-2020
Supply Chain Management: A Decision Making Framework by Louvain School of Management, Belgium
06-2020
Regulatory Affairs Officer
Mylan Laboratories Limited
08.2013 - 05.2016
Seminarian
ISPOR, Indian Habitat Center
11.2012 - 11.2012
M.Pharma - Pharmaceutical Sciences
DIPSAR
01.2011 - 03.2013
Vice-President
Society of Columbia Institute of Pharmacy
07.2009 - 03.2010
Student Editor
Columbia Institute of Pharmacy
01.2008 - 01.2009
B.Pharma - Pharmaceutical Sciences
Columbia Institute of Pharmacy
08.2007 - 05.2010
D.Pharma - Pharmaceutical Sciences
Jamia Hamdard
08.2005 - 10.2007