G Srilekha
Regulatory Affairs Associate @ Leading Pharma, LLC
United States
Lake Hiawatha
Pharmaceuticals
SPL, Annual Reports, Changes being effected-0, Changes being effected-30, End User letter, Change Control, NDC CODE, Labelling, Chemistry, Manufacturing, and Controls (CMC), Complaint Investigations, Product Complaints, Corrective and Preventive Action (CAPA), Biotechnology, Regulatory Requirements, U.S. Food and Drug Administration (FDA), English, Regulatory Submissions, Regulatory Compliance, Abbreviated New Drug Application (ANDA), Electronic Common Technical Document (eCTD)
Experience
Regulatory Affairs Associate
Leading Pharma, LLC
New Jersey, United States
Regulatory Affairs Intern
Leading Pharma, LLC
United States
RSO Proctor
Northeastern University
United States
Regulatory Affairs Consultant
Breegi Scientific, Inc.
United States
Prepared global regulatory strategies for Class I and Class II devices and analysed QMS, EU MDR, and ISO standards • As an SME, prepared Emergency Use Authorization Application for a Class II device to get approval from FDA. Analyzed required regulations for 510(K), PMA.
Ethics Conmittee Coordinator
ClinoSol Research
Hyderabad, Telangana, India
Overseeing and approving the clinical trial and its documents in order to protect the rights, safety and well being of the public.
Summer Internship
Dr. Reddy's Laboratories
Visakhapatnam, Andhra Pradesh, India
Assisted and worked with Quality Assurance, Quality Control, Manufacturing, Auditing, Regulatory departments as internee.
Education
Northeastern University
Regulatory Affairs
A pharmacist who has sound knowledge on subjects like Organic Chemistry, Analysis, Pharmacology, and Pharmaceutics. Along with my Undergrad, I did a diploma course in Clinical Research, Pharmacovigilance and Clinical Data Management which motivated me to pursue my masters in the field of Regulatory Affairs in order to safeguard the rights and health of the public. I have one year experience as Ethics Committee Coordinator where I have overseen the ongoing clinical trials and giving approvals to conduct the trials.
GITAM Deemed University
B.Pharmacy
G Srilekha's Contact Information
Phone
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