Radhadevi Nadimpalli
Girraween,NSW
Summary
A Strategic planner with a dynamic career in Regulatory Affairs; worked on Australia, New Zealand; India and Africa initial and post approval submissions. Multi-dimensional exposure in managing end-to-end regulatory product life cycle for pharmaceuticals (solid orals) from submissions to approvals including responses to deficiencies from health authorities. Interfaced with internal customers like plant QA, QC and CQA with respect to meet the post approval regulatory commitments and submission requirements. Timely approval of variations for regulated markets impacting product commercials and launch plans. Recognized for timely communication with TGA/CDSCO/MEDSAFE customers for initial, variation submissions and product launch preparations. Recognized for timely sunset clause exemptions request and grant of CDSCO Marketing Authorization. PI and CMC Preparation. Ability to work under pressure, excellent time management, conflict resolution, workplace shadowing.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Associate
NOVA PHARMACEUTICALS
02.2025 - Current
- Prepare, submit, and maintain regulatory documentation for product registrations, variations, and renewals in accordance with TGA requirements.
- Prepare and manage Category 1 applications, including major variations and new indications.
- Lead Category 3 and SRR submissions as part of lifecycle management.
- Coordinate and deliver complex CMC variations.
- Manage GMP clearances and product site changes.
- Maintain local labelling, packaging, and artwork submissions.
- Partner with internal cross-functional teams and liaise directly with the TGA.
- Provide input into regulatory strategy for upcoming submissions or product changes.
- Support broader departmental initiatives and contribute to team-wide regulatory excellence.
- Support local implementation of global regulatory strategies and processes.
- Maintain up-to-date knowledge of regulatory guidelines relevant to prescription medicines and otc.
- liaise with cross-functional teams including Quality, Medical, PV, Regulatory and Marketing to ensure compliance throughout the product lifecycle.
- Develop and maintain excellent working relationships with relevant regulatory bodies and government departments.
Regulatory Affairs Associate
Arrotex Pharmaceuticals
01.2022 - Current
- Responsible for the review and preparation of quality regulatory submissions to ensure timely approval from the TGA and Medsafe within own portfolio.
- Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance of products in own portfolio across the Australian and New Zealand markets.
- Working with the team to identify, prepare and submit EU MDR related TGA and/or Medsafe applications.
- Managing updates and maintenance of internal records and systems
- Accountable for assessing, coordinating, and compiling deficiency responses in a timely manner.
- Assisting in developing and maintaining Product Information, Consumer Medicine Information, labels, and other documentation as required within the timelines specified by the regulatory Agency.
- Assisting in developing draft artwork and liaise as necessary with Marketing to enable the production of labels, cartons, and foils.
- Keeping documentation such as Product Information, Consumer Medicine Information, and labelling (or equivalent) updated on database and external database to ensure most recent document is available.
- Perform regulatory affairs activities associated with product launches.
- Assisting in the coordination of regulatory affairs projects, as assigned.
- Perform additional duties as assigned by the Regulatory Affairs Manager.
- Monitoring progress of applications
- Assists the business by reporting the status of regulatory affairs activities in various project meetings or upon request from other departments.
- Liaise with functional groups (Quality Assurance, Supply Chain, Pharmacovigilance/Medical Information and Marketing) to request and/or provide documents relevant to Change Control and product maintenance.
- Communicate with external parties, such as agents, suppliers, and in-licensing partners, to request and/or provide data relevant to regulatory submissions.
- Provide regular reports on Regulatory Affairs activity.
Regulatory Affairs Officer
CMPS Pharmaceuticals
06.2021 - 12.2021
- Dossier preparation in accordance with overseas authorities' requirements
- Responding to queries from TGA and other health authorities
- Review and approval of packaging materials and other artwork
- Preparation of the registration documentation in timely manner
- Preparation of marketing authorization in timely manner
- Assistance in documentation system
- Identifying, preparing, and submitting documentation to the relevant region regulatory bodies; including but not limited to the Therapeutic Goods Administration.
- Preparation of formulation certificates
- Collecting technical and general documentation
- Applying for Free Sale Certificate, Certificate of Origin from Australian Business Chamber
- Legalization of documents
- Monitoring progress of applications through the regulatory system
Jr. Manager - Regulatory Affairs
Vivo Biotech PVT Limited
01.2014 - 01.2016
- Support the local Regulatory Affairs(RA) team to prepare regulatory submissions to TGA and CDSCO.
- Submission of manufacturing changes, updates to PI/CMI/DS and labeling changes.
- Ensure maintenance of inline products on the market by performing various regulatory activities related to change control processes for labeling, CMC, and artwork.
- Provide expertise and guidance to global study teams regarding regulatory activities, review BMR and MFR documents.
- Preparation of marketing authorization application (Module1-5) in CTD format as per Indian regulatory guideline for a development product.
- Preparation of various application like Forms [ 8,12, 29, 40, 44], NOC for test license, import/export/BA/BE, various certificates [COPP, FSC, GMP, Market standing] for further submission to DCGI.
- Resolving queries from various countries Regulatory bodies and other agencies.
- Assisting on the preparation of Common Technical Documents (CTD) according to ICH guidelines.
- Updating of CTD (Modules I-V) as per the changes occurring in Product documentation.
- Preparation of link documents according to the Country regulations for assigned Products.
- Collaborating with team members across departments to meet RA requirements.
- Coordinating with different departments and preparation of the query response raised by different regulatory bodies (responding, reviewing, follow up to audit points).
Intern – Regulatory Affairs
Micro Labs Ltd. (R&D)
04.2013 - 10.2013
- Dossier filing to Australia, India, and African markets.
- Assisted with the development and maintenance of regulatory files, records, and reporting system.
- Regulatory requirements for filing a dossier (for Marketing Authorization), reviewing technical documents, compilation as per country specific requirements and addressing queries in case of deficiencies.
- Participated in the Dossier filing by various regulatory agencies via Senegal, Cameroon, Ivory Coast and Sudan for prescription drugs.
- Assist with label development and review for compliance before release.
- Assist in SOP development and review.
- Learnt ECTD Pharma ready software for e-filing.
Pharmacy Intern
Fortis Hospital
09.2009 - 08.2010
- Dispensed medication according to Prescription.
- Verified Patient data and billing information.
- Assisting with other projects and activities as required
- Performed transfers of prescriptions and communicated directly with doctors' offices.
- Efficiently answered phone calls and processed high volume of prescription orders.
- Maintained pharmacy stocks.
- Educated and advised patients and worked on the improvement of customer satisfaction, Collaborated with healthcare professionals.
Education
Master’s in pharmacy - M. Pharmacy
J.S.S University
India12.2013
Bachelor’s in pharmacy - B. Pharmacy
R.G.U.H.S University
India06.2008
Skills
- Regulatory Affairs
- TGA, New Zealand and AFRICA submissions
- Medical Device
- ICH Quality Guidelines
- Post approval variations
- Renewals
- Australia
- Category 1 applications
- Africa
- ACTD Submission
- Excellent oral and written communication skills
Certification
- ECTD Fillings Certification RAAJ GPRAC PVT LTD! Finished 2021
- ARCS Certification in Introduction to Regulatory Affairs in Australia for Prescription and Non-Prescription Medicines
Timeline
Regulatory Affairs Associate
NOVA PHARMACEUTICALS
02.2025 - Current
Regulatory Affairs Associate
Arrotex Pharmaceuticals
01.2022 - Current
Regulatory Affairs Officer
CMPS Pharmaceuticals
06.2021 - 12.2021
Jr. Manager - Regulatory Affairs
Vivo Biotech PVT Limited
01.2014 - 01.2016
Intern – Regulatory Affairs
Micro Labs Ltd. (R&D)
04.2013 - 10.2013
Pharmacy Intern
Fortis Hospital
09.2009 - 08.2010
Bachelor’s in pharmacy - B. Pharmacy
R.G.U.H.S University
Master’s in pharmacy - M. Pharmacy
J.S.S University