Shubham Shenvi Shirwaikar
Mumbai
Summary
- Regulatory Affairs professional with a demonstrated history of working in pharmaceutical industry.
- Skilled in review and assessment of the change controls, compilation and submission of variations for EU, APAC, LATAM region and International markets
- Common technical document (CTD) filing, post-approval submissions, technical agreement and regulatory compliance file review and approval, RA databases like Veeva vault, Reliant, Pharmaceutical GMP processes and quality systems like Trackwise, PowerBI with 8.5 years of total experience.
- Client communication & coordination, project management, Regulatory compliance and enforcement, Maintaining good relation with client and stakeholder to ensure smooth submission
Overview
11
11
years of professional experience
2017
2017
years of post-secondary education
Work History
Lead Associate
Genpact India Pvt. Ltd.
Mumbai
11.2023 - Current
- Based on the provided details for the role of Lead Associate at Genpact India Pvt. Ltd., here are eight experience statements tailored to align with the job title and responsibilities typically associated with this position:
- Led cross-functional teams to enhance operational efficiency, resulting in improved project delivery timelines and stakeholder satisfaction.
- Managed client communications by addressing inquiries and resolving issues, ensuring high levels of customer engagement and retention.
- Streamlined daily workflows by incorporating best practices, which reduced process bottlenecks and enhanced team collaboration.
- Mentored junior associates, sharing industry knowledge and best practices to improve team performance and individual competencies.
- Responded to customer questions and complaints by resolving issues personally or referring to management.
- Analyzed client reports and provided actionable insights, contributing to strategic decision-making and improved service delivery.
Regulatory Affairs Associate
Teva Pharm India Pvt. Ltd.
Mumbai
12.2022 - 10.2023
- Life-cycle management across Europe and International markets covering variety of products & procedures.
- Review and assessment of the change controls, compilation and submission of variations for EU, APAC region and International markets
- Handling customer business- query response, document review, point of contact for communication, variation compilation and submission, etc.
- Coordinated in product transfers and site transfers by providing necessary regulatory feedback and submission
- Collaborated with cross-functional teams to prepare and submit regulatory documentation, significantly improving submission accuracy and efficiency
- Monitored changes in regulatory requirements and communicated updates to stakeholders, facilitating informed decision making across departments
Regulatory Affairs Associate
Watson Pharma Pvt. Ltd. (A group company of Teva)
Verna
03.2021 - 11.2022
Regulatory Affairs Associate
Teva Pharm India Pvt. Ltd.
Verna
12.2019 - 02.2021
Quality Assurance Executive
Sanofi India Ltd.
Verna
04.2018 - 12.2019
- Routine IPQA activities like in-process quality control checks in compression and coating of tablets, line clearances during batch to batch and product to product change over and monitoring activities in dispensing, granulation and tablet compression, sampling of bulk tablets and granules
- Coordinated in the activities like point-sampling of granules, monitoring of validation batches, transport validation, cleaning validation and hold time
- Preparation of APQR for various product
- Involved in monitoring towards quality, ensuring the quality systems & QA documents for cGMP requirements.
- Identification of deviation by observation and review
- Manpower management and conducted training program
Community Pharmacist
Divine Medicals
Margao, Goa
09.2017 - 03.2018
Intern
Zydus Cadila
Kundaim, Goa
06.2015 - 06.2015
- One month industrial training as intern in Zydus Cadila Healthcare Ltd.
Education
Master of Pharmacy - Pharmacognosy
Goa College of Pharmacy
Panaji, Goa 08.2015 - 08.2017
Bachelor of Pharmacy - Pharmacy
Goa College of Pharmacy
Panaji, Goa 08.2011 - 06.2015
HSSC - Science
Rosary Higher Secondary School
Navelim, Goa 06.2009 - 05.2011
Holy Cross Institute
Quepem, GoaSkills
- Client communication & coordination: organising client meetings, updating MOM, handling client queries & escalations
- Regulatory compliance and enforcement
- Critical thinking-synthesize complex information and convert it in a comprehensible manner
- Preparation of module sections with required information as per NTA guidance
- Good communication-to establish relationship between regulatory authorities and different site's technical functions
- Developing action plans and prioritization of work
- Integrate regulatory knowledge into business stretegy
- Regulatory information management systems/RA databases
- Pharmaceutical GMP processes and quality systems
Languages
English
First Language
Hindi
Advanced (C1)
C1
Marathi
Upper Intermediate (B2)
B2
Konkani
Proficient (C2)
C2
Accomplishments
- GPAT Qualified 2015- Score:161, stood 5th in Goa, with 550 All India Rank
- Silver star performer of the year in the year 2022 in Teva Pharm India Pvt. Ltd.
- Bronze star performer of the year in the year 2025 in Genpact India Pvt. Ltd.
Affiliations
- Conducted internal trainings for the team on EU variation guidelines
Hobbies
- Musical Instrument-Tabla
- Gyming and bodybuilding
- Travelling
- Sports- Cricket and Badminton
Additional Information
- Confident, dedicated to work, hardworking and passionate about delivering outstanding service, flexible to any work condition
- Team player
- Always open to take new tasks and new responsibilities
- Focuses on simplification of work
- Open to learning and gaining knowledge
- Proven ability to coordinate and guide team members
Timeline
Lead Associate
Genpact India Pvt. Ltd.
11.2023 - Current
Regulatory Affairs Associate
Teva Pharm India Pvt. Ltd.
12.2022 - 10.2023
Regulatory Affairs Associate
Watson Pharma Pvt. Ltd. (A group company of Teva)
03.2021 - 11.2022
Regulatory Affairs Associate
Teva Pharm India Pvt. Ltd.
12.2019 - 02.2021
Quality Assurance Executive
Sanofi India Ltd.
04.2018 - 12.2019
Community Pharmacist
Divine Medicals
09.2017 - 03.2018
Master of Pharmacy - Pharmacognosy
Goa College of Pharmacy
08.2015 - 08.2017
Intern
Zydus Cadila
06.2015 - 06.2015
Bachelor of Pharmacy - Pharmacy
Goa College of Pharmacy
08.2011 - 06.2015
HSSC - Science
Rosary Higher Secondary School
06.2009 - 05.2011
Holy Cross Institute