Valuva Raghavender
Wanaparthy
Summary
Skilled regulatory affairs professional with 3.9 years of experience negotiating regulatory approval processes and an post graduate in M. Pharmacy degree. Adept at setting priorities, managing tasks to fulfil deadlines, and paying close attention to detail. outstanding judgement and problem-solving capabilities, as well as strong interpersonal, written, and vocal communication skills.
Overview
6
6
years of professional experience
Work History
Regulatory Affairs – Jr. Executive
Hetero Labs Limited
05.2021 - Current
- Compilation of dossiers in CTD & eCTD format (Module 1 – 5) for product registration in Middle East Region (UAE, Egypt, and Saudi)
- Assisted in the preparation of nearly 30 dossier for annual plan which results in the efficiency of regulatory affairs team
- Effectively analysed and evaluated regulatory submission which all applicable in regulation during the submission of dossier
- Reviewing of product labelling, pill making according of SMPC, Reviewing, and approving of commercial art works.
- Filing Variation in-line with the current monographs and marketing strategics.
- Knowledge in the B.E and CDP according to U.S.A and Europe
- Communicate with the cross- functional team for the document’s requirement
- Handling the Query’s which are received from the Regulatory Authority.
- Preparation registered product information (RPI) for the approved products as per the Registration certificate and approved dossier
- Requesting Finished Product samples, working standards and Impurities to respective plant teams in-order to support product registrations and for commercial activity
- Requesting liaisoning team about Manufacturing licence and Finished Product GMP’s and supporting the requested data for Registration of Products
- Co-ordinating with packaging development team regarding Registration art works for dossier submissions and for commercial art works
- I handled dossiers like Oral dosage forms (tablets, capsules, solutions and Injectables)
- I have also knowledge on emerging markets like middle east (Jordan, Syria, Oman, Yemen, Qatar, Baharin), Latam region (Chile, Columbia, Gauthemela, Hondorus, Dominic Republic, Tibago), Africa region, Brazil, Mexico and China countries
Trainee in QA department
Bharath Biotech International Limited
04.2019 - 04.2021
- Worked as Trainee in QA department at Bharath Biotech International Limited from April 2019 to April 2021
Education
M PHARMA - PHARMACEUTICS
MALLA REDDY COLLEGE OF PHARMACY
HYD01.2021
B PHARMA - undefined
PALAMURU UNIVERSITY
MAHABOOB NAGAR, TS State06.2018
Skills
- Pharmaready (eCTD) and Lorenz eValidator
- Regulatory Information Management System
- Document Management
- Project Coordination
- Risk Assessment
- Quality Management System
- Proficiency in Microsoft office programs like Word, Excel, power point
- Accuracy and attention to details
- Adaptability and flexibility
- Ability to work independently, and as a part of the management team
Hobbies and Interests
Travelling, Listening to music, Dancing, Cooking
ADDRESS
- H.No: 33-113
- Pangal Road, Wanaparthy (Dist.), Telangana (State).
Timeline
Regulatory Affairs – Jr. Executive
Hetero Labs Limited
05.2021 - Current
Trainee in QA department
Bharath Biotech International Limited
04.2019 - 04.2021
M PHARMA - PHARMACEUTICS
MALLA REDDY COLLEGE OF PHARMACY
B PHARMA - undefined
PALAMURU UNIVERSITY
Similar Profiles
Pusapati Jagannadha RajuPusapati Jagannadha Raju
Assistant Manager at Hetero Labs LimitedAssistant Manager at Hetero Labs Limited
K. Sandeep Kumar ReddyK. Sandeep Kumar Reddy
Deputy Manager – Quality Assurance at Hetero Labs LimitedDeputy Manager – Quality Assurance at Hetero Labs Limited
Kapil NeyyalaKapil Neyyala
QA Manager at Hetero Labs limitedQA Manager at Hetero Labs limited
SAI KUMAR YADAVSAI KUMAR YADAV
COURSE ON SUPPLY CHAIN FOUNDATIONS at PROJECT MANAGEMENTCOURSE ON SUPPLY CHAIN FOUNDATIONS at PROJECT MANAGEMENT
KOKKI SUDHAKAR KOKKI SUDHAKAR null
Manager at Canara BankManager at Canara Bank