AKSHAY DR
Bengaluru,KA
Summary
Dynamic Regulatory Affairs Associate with over 5 years at Pharma Industry (Regulatory Affairs), adept in submission preparation and regulatory strategy. Excelled in leveraging analytical skills and intense communication to enhance regulatory processes, achieving streamlined operations. Proficient in eCTD and Veeva Vault, demonstrating exceptional adaptability and teamwork in fast-paced environments. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
5
5
years of professional experience
Work History
Regulatory Affairs Associate
Parexel International Limited
08.2021 - Current
- Experienced Regulatory professional with Master Degree in Pharmacy (Dept of Quality Assurance) and having 5 + years of experience in Pharmaceutical Industry.
- A competent & dynamic professional with sound experience in Regulatory Affairs, Quality Assurance and Formulation.
- Specialized in Pre-approval & post approval activities and Handling of Agency's queries by drafting the response, knowledge on variations related to CMC activities/RFI solving for EU/US markets by exploiting my professional experience seeking myself in a highly responsible position.
- A friendly professional, able to establish positive relationships with clients and colleagues.
- Support submission planning - Applying intelligence and negotiation skills to develop Regulatory strategy. Create and maintain Regulatory Submission Plan including creation/review documents.
- Support submission of Regulatory files, Handling Change Requests & Deviations, response to RSI/ HA query worldwide, Annual Reporting and maintenance of marketing authorization globally.
- Support to NDA, Renewals & Post Approval Changes.
- Hands on experience with Veeva Vault (Submission & Registrations).
- Facilitated smooth communication between departments by serving as the primary liaison between regulatory affairs and other functional areas within the organization.
- Contributed to cost reduction efforts by identifying opportunities for process improvement within regulatory affairs operations.
- Provided exceptional administrative support to Regulatory Affairs team members during critical projects or periods of high workload.
Executive Regulatory Affairs
Strides Pharma Science Limited
06.2019 - 08.2021
- Responsible for compilation and assist team and regulatory submissions by collating documents per updated regulatory requirements.
- Pre-publishing activities such as document preparation (internal hyperlinking and creating bookmarks).
- Handling of post approval activities including Type IA, IB and Type II variations and Annual reports/
supplements. - Review and approval of documents required for compilation of regulatory submissions and deficiencies responses.
- Ensure relevant SOPs are understood and practiced on routine basis.
- Preparation, Review and Compilation of regulatory documents for variations & Annual Reports, being filed to EU/US markets.
- Uploading and formalization of documents in eCTD format using eCTD dossier management software.
- Co-ordinate with the cross functional departments for primary data documents, required for submission.
- Collate and review primary data received from different departments towards regulatory dossier compilation.
- Perform registration renewals and variations during the life cycles of the products for dossiers filled in
EU market. - Review of commercial artworks and maintain the PLCM activities for products in EU market.
Education
Masters in Pharmacy - Quality Assurance And Regulatory Affairs
Acharya & BM Reddy College of Pharmacy
Bengaluru06.2019
Skills
- Submission preparation
- Regulatory Agency Liaison
- Good Manufacturing Practices
- Quality Management Systems
- Intense Communication skill
- License Maintenance
- Data Gathering
- Electronic Common Technical Document
- Change Control Management
- ICH Guidelines
- Regulatory Submissions
- Regulatory Strategy
- Regulatory Intelligence
- Pharmaceutical Regulations
- Risk Management
- Time Management
- Problem-Solving
- Problem-solving abilities
- Multitasking Abilities
- Analytical Skills
- Written Communication
- Professionalism
Others -
- MS-OFFICE, PDF Properties, Trackwise, LIMS, PLM, DCM, LMS and SAP Handsome experience in utilization of eCTD Advanced Skill – Maintenance and handling RIMS (Veeva Vault)
- Highly fluent in English enabling good level communication skill (capable to handle client's calls/meetings)
- Positive attitude and Enthusiastic in teamwork
- Quick in learning new technologies/system updates and guideline updates
- Flexibility and Adaptability to work in any environment
Accomplishments
- Achieved [Shooting Star of the year-2020] through effectively helping with Timely submission and Intense support for over 40+ products.
- Collaborated with team of EU,US & ROW in the development of various products.
- Used Microsoft Excel to develop inventory tracking spreadsheets.
- Documented and resolved sampling issues which led to Approvals of various DCPs.
Archery and 0.177 Cal Rifle sharp shooter
Hobbies being a passion for Archery and rifle shooting had always inspired me from childhood and a dream to chase. It helps me relax and focus more on my goals and help me think straight during high stress situations.
Languages
English
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
Kannada
Bilingual or Proficient (C2)
Telugu
Advanced (C1)
Tamil
Advanced (C1)
Malayalam
Elementary (A2)
Spanish
Elementary (A2)
Timeline
Regulatory Affairs Associate
Parexel International Limited
08.2021 - Current
Executive Regulatory Affairs
Strides Pharma Science Limited
06.2019 - 08.2021
Masters in Pharmacy - Quality Assurance And Regulatory Affairs
Acharya & BM Reddy College of Pharmacy
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