MANASAVEENA AKUTHOTA,MS (Pharm)
Hyderabad, India
Mail :manasaveena.akuthota AT gmail.com
CAREER OBJECTIVE :
An enthusiastic, creative and self-motivated with strong educational and pharmaceutical background for seeking a rewarding position with a well-established organization where my experience effectively utilizes, and nurtures my analytical and technical skill.
PROFESSIONAL SUMMARY :
Strongly reliable and focused Regulatory Affairs Specialist with great depth and breadth of experience in operations and complicance of regulatory submissions to US FDA and EMEA.
WORKEXPERIENCE :
** Dec 2020–Till date : RA CMC Submission Coordinator at Novartis Health care Pvt Ltd
** May 2017–Dec 2020 : Senior Associate in Regulatory CMC at Freyr Solutions Pvt Ltd (Onsite contractual External associate to Novartis)
** Aug 2014 – Apr 2017 : Associate Analyst in GlobalData Plc. in Pharma e-Track dynamic updates of Regulatory and Clinical trials database
RESPONSIBILITIES IN CURRENT ROLE :
** To Provide operational, regulatory and compliance support to RA CMC dept in accordance to defined requirements to guarantee timely preparation of high-quality CMC regulatory submissions and associated compliance information throughout the life cycle.
** To perform compliance and operational support including QC and DA checks, CMC contact for some countries and compliance/ regulatory database entry and reports
** To prepare, co-ordinate and track CMC submissions for delivery to RA Operations – USSC activity
** Annual report writing for IND & NDA for US FDA
** Acquire and maintain GMP Certificates and Manufacturing Authorizations required for RA CMC submission in the Document Management System
** Hands-on-training sessions for Format checking/Novstyle and to ensure compliance of documentation to internal company standards and external regulatory guidelines
** Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies
** Preparation of drug product dossiers for various post approval changes (variations). Knowledge on EU filing procedures, US filing procedures
** Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
** Assisting in writing CMC Module 3 (Quality) for Drug Product Renewals Maintaining product lifecycles using special soft wares like Dragon, NovaRim
RESPONSIBILITIES IN PREVIOUS JOB :
** Project management and maintaining life cycle activities Change controls database knowledge
** Working on regulatory and clinical database, ensuring updated reports on timelines for significant liaison between the company and health care professionals
** Regulatory report writing, client quires and data review on different therapy areas
** Compiling clinical trial results from abstracts, posters from conferences and scientific journals To author, review and manage high quality clinical and safety documents
** Contributing to planning of data analyses and presentation used in CSRs and submission documents Capturing the company latest updates and manual profiling of new clinical trials from news, milestones, investor presentations and SEC filings
** Report scheduled updates on various marketed, pipeline products, lead molecules and their life-cycles with stage of developments for various indications associated clinical trials
** Updating the drug profile, sponsor details and investigator information based on primary and secondary research
APPRECIATIONS & AWRADS :
** Received Beacon Award for Embracing operational excellence every day 2022
** Received Galaxy Team award for the resilience in the drug approval for Scemblix 2021
** Received Outstanding award in Client Appreciated performance category at Freyr solutions in 2018
** Received quick performer award for achieving the targets before timelines at GDRC in 2016
CORE COMPETENCIES :
** Comprehensive knowledge of Clinical Trials, Phases, Regulatory authorities
** Basic knowledge on Format specifications of CTD, eCTD, DMF, IND, ANDA and NDA filings, Drug and cosmetic act, Y schedule
** Excellent written, verbal communication and a quick learner with high levels of adaptability and ability to take initiative and able to work independently with minimal supervision
** Multi-tasking and coordinate various activities under high pressure and time constraints
ACADEMIC QUALIFICATIONS :
** MS (Pharm) (2012-2014) : cGPA – 9.66 (on scale of 10) Department of Pharmacology and Toxicology, NIPER, Hyderabad, Balanagar, Hyderabad, AP
** B.Pharm (2008-2012) : 83.5% Learner’s land college of Pharmacy (Affiliated to JNTU) Warangal
** Intermediate (2008) : 94.2% New Science junior college, Warangal
** High School (2006); 90.00% St.Theresa High school, Warangal
ACADEMIC ACHIEVEMENTS :
2014 : Secured 2nd position in the Department of Pharmacology & Toxicology in MS (Pharm), NIPER Hyderabad
2012 : Qualified GPAT-2012 with AIR-1322
2012 : Qualified NIPER JEE with AIR of 261
2012 : Qualified PGECET with 36 rank State level
WORKSHOP AND CONFERENCES ATTENDED :
** Participated in international conference “Drugs for the future : Infectious Diseases” at NIPER Hyderabad during March 2014
** Presented a poster in IPSCON- Bangalore held during December-2013
** Participated in workshop on Drug Development : Conceptualization to Commercialization (Drug discovery, 2- Medical Writing, Regulatory Affairs & Pharmacovigilance & 3-Marketing & IPR) conducted by NIPER in collaboration with NOVARTIS, 2012
PUBLICATIONS AND ABSTRACT :
1.
Manasaveena.A, Veera Ganesh.Y, Reddemma.S, Manish Kumar.J, Naidu.V.G.M, Ashutosh Kumar. Evaluation of neuroprotective effect of Melatonin in animal models of peripheral neuropathy induced by streptozotocin and Oxaliplatin. Indian journal of Pharmacology 2013, 45;238-239
2. Manasaveena.A, A. Areti, V.G. Yerra, A. Kumar, Resveratrol attenuates Oxaliplatin induced neuroinflammation and oxidative stress via NF- ion in experimental models of peripheral neuropathy. Biochemical Biophysical Research Communications 2014 (2014). (conference Paper)
3. Manasaveena. A, V.G. Yerra, A. Areti, P. Komirishetty, and A. Kumar, Melatonin ameliorates MAPK mediated neuroinflammation in in vitro and in vivo models of Oxaliplatin induced peripheral neuropathy. Journal of Pineal Research 2014 (2014). (Manuscript under preparation)
DECLARATION :
Here by I declare that the information given above is true to the best of my knowledge.
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