Mary Param Jyothi Palaparthi
Hyderabad
Summary
Experienced professional with a strong background in regulatory affairs (Europe/Australia and New Zealand markets- post approval). Strong work ethic, adaptability, and capable of managing projects and collaborating effectively with teams. Committed to continuous learning and staying current with industry trends to contribute to organizational success.
Proactive and versatile professional with a dedication to quickly adapting to new challenges.
Strong problem-solving abilities and focused on supporting team success and achieving positive results.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Executive
Regulatory Affairs
Hyderabad
09.2021 - Current
• Authoring / writing and review of CMC sections of dossier
• Critical review of design stage documents (specifications, controls and protocols) to ensure that regulatory requirements are fulfilled
• Assessment of change controls to evaluate the regulatory impact and to strategize the post approval submissions
• Co-ordination for collection of post-execution data from various functions and review for compliance against the design specifications, controls and protocols.
Collaboration with various cross-functional team members for the timely conclusion of action items identified for responding to deficiencies.
• Review and to check the accuracy of information in various status and database maintained at department / organization level
• Ensure compliance of regulatory submissions with current regulations and guidance
• Contributed individually effectively to ensure that target submissions are achieved in time
Education
Master of Pharmacy (9.43 - SCPA) -
Center For Pharmaceutical Sciences
Hyderabad05-2021
Bachelor of Pharmacy (81.29%) -
Marri Laxman Reddy Institute of Pharmacy
Hyderabad06-2018
Board of Intermediate Education (85%) -
Sri Chaintanya Junior College
Hyderabad05-2014
Board of Secondary Education (9.0 - SGPA) -
Jai Bharathi High School
Hyderabad05-2012
Skills
- Organization and time management
- Friendly, positive attitude
- Flexible and adaptable
- Computer skills
- Technical writing
- Document review
- Regulatory compliance
- Attention to detail
Languages
Telugu
First Language
English
Advanced (C1)
C1
Hindi
Upper Intermediate (B2)
B2
Affiliations
- Handicrafts
- singing
- Cooking
Accomplishments
- Department topper (Pharmaceutical Analysis) in M Pharmacy (JNTUH)
- Gold medalist / Secured 1st rank in B Pharmacy for all the 4 years (MLRIP)
- Secured prizes for best oral presentation in MLRIP and JNTUH.
- Secured 3rd rank in board of secondary education (JBHS)
Certification
- Best oral presentations
- Pharmacist certificate from Pharmacy council of India
Timeline
Executive
Regulatory Affairs
09.2021 - Current
Master of Pharmacy (9.43 - SCPA) -
Center For Pharmaceutical Sciences
Bachelor of Pharmacy (81.29%) -
Marri Laxman Reddy Institute of Pharmacy
Board of Intermediate Education (85%) -
Sri Chaintanya Junior College
Board of Secondary Education (9.0 - SGPA) -
Jai Bharathi High School
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