Profile
Anuradha M. - 21708 Regulatory Affairs Associate from Canada
Completed
0
Assigned
0
Invites
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Posted
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Payments
$0.00
Rate/hr
$40.00
User ID
Anuradha M. - 21708
Brampton, Canada
5:02 AM, GMT -05:00

Anuradha M. - 21708 Regulatory Affairs Associate from Brampton

About

• In-depth experience working with project teams and providing research and advice on compliance with FDA and Health Canada guidelines, SOP preparation, technical writing and GMP documentation. • Actively participated in ISO and US FDA compliance audits. • Familiar with the drug and medical device development process -cGMP, GDP, GLP, GCP, QSR, IND, NDA, BLA, 510k, PMA, informed consent, IRB review, and ethical principles in clinical research • Solid working experience in the pharmaceutical industry – GMP documentation, Regulatory audits, Drug listings, Establishment Registrations, DMF registrations, handling deficiencies, amendments, annual updates, and letters of authorisations. • Experienced in creating and publishing documents in eCTD, NeeS and paper format • Knowledgeable of MDSAP program and ISO 13485 requirements. • Methodical, quick-learner and highly independent team player, problem solver and troubleshoot any scientific issues. • Ability to multi-task and to establish and maintain good working relationships at all levels. • Strategic thinker with strong attention to detail and with excellent communication skills • Excellent computer skills in MS Office (word, excel, power point, access, and outlook) and adobe acrobat.
Occupation

Regulatory Affairs Associate

Work experience
2022 - Present
Specialist - Regulatory Affairs
SPharm Inc.
2020 - 2022
Associate - Quality Assurance and Regulatory Affairs
Septa Pharmaceuticals Inc.
2004 - 2013
Senior Associate - Quality Assurance and Regulatory Affairs
Divi's Laboratories Limited
2002 - 2003
Associate - Quality Assurance and Regulatory Affairs
Divi's Laboratories Limited
Education
2019 - 2019
Sheridan College
Certificate
2016 - 2017
Seneca College of Applied Arts & Technology
Graduate Certificate
1998 - 2002
JNTU University
Bachelor of Technology
Calendar
February 2023
SU M TU W TH F SA
Available
Unavailable

Skills

510(k)
13 Y
Active Pharmaceutical Ingredients
13 Y
Amendments
13 Y
Audit
13 Y
Clinical Research
13 Y
Compliance Audit
13 Y
Informed Consent
13 Y
ISO 13485
13 Y
Multi-tasking
13 Y
Problem Solving
13 Y
Project Team Skills
13 Y
Teamwork
13 Y
Technical Writing
13 Y
Troubleshooting
13 Y

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