Priyanka Arram
Pharma
Secunderabad
Summary
Experienced Licensing Specialist and Project Management Associate skilled in Regulatory Affairs and Project Management. Demonstrated proficiency in ensuring regulatory compliance, securing licenses, and preparing regulatory submissions. Capable of coordinating cross-functional teams, including product development, and leading weekly reviews to assess constraints. Proficient in planning, execution, risk mitigation, and team coordination to deliver projects within scope and on schedule. Results-driven professional aiming to utilize organizational and regulatory knowledge to enhance team performance.
Overview
1
1
year of professional experience
6
6
years of post-secondary education
1
1
Certification
1
1
Language
Work History
Project Management Associate &Licensing Specialist
Dr. Reddy's Laboratories
Hyderabad
09.2023 - 01.2025
- Led and managed project deliverables from development to filing, ensuring compliance with timelines.
- Coordinated cross-functional teams (Development, Manufacturing, RA, QA, QC) to meet project goals.
- Oversaw project tracking and reporting, delivering regular updates to senior management.
- Involved in planning, monitoring, budgeting and tracking various generic projects through entire life cycle from project initiation to till filling.
- Managed the application process for CT 10, CT 15, and CT 16 import licenses, ensuring compliance with regulatory standards.
- Obtained Form 25 manufacturing licenses for pharmaceutical products, ensuring adherence to quality and safety standards.
- Coordinated with cross-functional teams to ensure timely submission of regulatory documents and compliance with regulatory requirements.
- Managed specific export permissions for DS (Drug Substance) and DP (Drug Product) API formulations, ensuring compliance with export regulations and documentation requirements.
- Assist in the development and maintenance of Regulatory policies and procedures related to Regulatory Systems and updated Guidance documents.
- Demonstrated keen understanding of regulatory frameworks relevant to various global markets.
- Prepare dossiers and submissions for Health Authorities (HA) in emerging markets, ensuring compliance with country-specific regulatory requirements.
- Coordinated effectively with clients to address technical queries and ensure alignment with regulatory requirements.
- Maintains SOPs related to RA activity and suggests update to the QMS.
- Developed excellent working knowledge of industry trends and improvements in processes.
- Built and maintained strong working relationships across company to help implement internal standards.
- Oversaw horizon scanning, identifying changes in regulations and applying strategies to remain compliant.
- Proficient in SAP for managing inventory, procurement, and supply chain processes.
- Experienced in utilizing IBM Notes for email communication, calendar management, and document collaboration.
- Skilled in SharePoint access for document sharing, version control, and team collaboration.
Education
M. Pharmacy - Pharmaceutical Sciences
Malla Reddy College of Pharmacy, Osmania University
Hyderabad 01.2013 - 01.2015
B. Pharmacy - Pharmaceutical Sciences
St.John College of Pharmacy, Kakatiya University
Hanamkonda 01.2007 - 01.2011
Skills
Legal Database Management
Global Regulatory Systems
Document Management
Project management
Cross-functional Collaboration
Good communication and interactive skills
Ability to work as a team player as well as an individual
Ability to work in rapidly changing environments
Risk Mitigation Strategies
Data Tracking and Analysis (including advanced spreadsheet skills, Spotfire etc)
Microsoft Office
Multitasking
Basic knowledge of SAS with clinical trails
Personal Information
- Father's Name: MADHAVA REDDY
- Spouse's Name: RAHUL REDDY
- Date of Birth: 10/05/1990
Projects
Formulation and Evaluation of Mucoadhesive Buccal Films Impregnated with Nifedipine Nanosuspension, 1 year, Malla Reddy College of Pharmacy, Maisammaguda, Hyderabad, Telangana, Nifedipine is a BCS-II class drug and used as a anti-hypertensive. The drug delivery system has been designed as a novel platform for potential buccal delivery of drugs having poor solubility, poor permeability and having first-pass metabolism and to increase the solubility of drug by nanosuspension.
Disclaimer
I, here by, declare that the information furnished above is true, correct and complete to the best of my knowledge.
Certification
SAS with clinical trails
Timeline
Project Management Associate &Licensing Specialist
Dr. Reddy's Laboratories
09.2023 - 01.2025
M. Pharmacy - Pharmaceutical Sciences
Malla Reddy College of Pharmacy, Osmania University
01.2013 - 01.2015
B. Pharmacy - Pharmaceutical Sciences
St.John College of Pharmacy, Kakatiya University
01.2007 - 01.2011
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