Priyanka Sharma
Regulatory Affairs Officer
Summary
Seasoned Regulatory Affairs Officer with 4.4 years in executing regulatory affairs initiatives for API industry.
Prepares and submit Drug Master Files to various regulatory agencies and handles query responses as well. Works well with consulting cross-functional teams on minimizing regulatory risk. Goes above and beyond to manage priorities and problem-solve with quick turn-around expectation.
Overview
4
4
years of professional experience
2
2
Languages
Work History
Regulatory Affairs Officer
IOL Chemicals and Pharmaceuticals Limited
07.2020 - Current
- Prepared and maintained document inventory for core dossier preparation and ensured high quality submissions according to agency guidelines.
- Reduced response time to regulatory/customer inquiries by establishing a robust tracking system for all incoming communications.
- Evaluated proposed changes to products or manufacturing processes for potential impact on regulatory status, ensuring minimal disruption to existing approvals.
- Facilitated smooth communication between departments by serving as the primary liaison between regulatory affairs and other functional areas within the organization.
- Managed fees and applications, tracked product progress and handled all responses to regulatory inquiries.
- Consulted with regulatory representatives to manage filings, applications, and reports.
- Provided responses to regulatory agencies regarding product information or issues.
- Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products.
- Directed documentation efforts to comply with domestic and international regulations and standards.
- Led efforts to obtain necessary certifications for products such as such as Manufacturing license, GMP Certifications, NOCs (Export and Dual Use), Written Confirmations, FSSAI, allowing for increased market access and revenue growth.
Education
Master of Science - Industrial Chemistry
UICET, Panjab University
Chandigarh, India 04.2001 -
Bachelor of Science - Science
College of Basic Sciences
Palampur, India 04.2001 -
Class XII - CBSE
DAV Sr. Sec. Public School
Shimla 04.2001 -
Class X - ICSE
Shimla Public School
Shimla 04.2001 -
Skills
Regulatory policies and filings
Timeline
Regulatory Affairs Officer
IOL Chemicals and Pharmaceuticals Limited
07.2020 - Current
Master of Science - Industrial Chemistry
UICET, Panjab University
04.2001 -
Bachelor of Science - Science
College of Basic Sciences
04.2001 -
Class XII - CBSE
DAV Sr. Sec. Public School
04.2001 -
Class X - ICSE
Shimla Public School
04.2001 -
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