Pallavi Siddhesh Sawant
Mumbai
Summary
Regulatory Professional with more than 12 years of extensive industry expertise in spearheading regulatory submissions and securing approvals across EU and ROW markets. Accomplished Regulatory Affairs Manager with a proven track record at FinOrion Pharma, specializing in lifecycle management and regulatory submissions. Expert in project management and cross-functional teamwork, I significantly enhanced regulatory efficiency and compliance. Mentored junior staff, ensuring high-quality training in regulatory procedures and guidelines.
Overview
14
14
years of professional experience
Work History
Manager – Global Regulatory Affairs
FinOrion Pharma India Private Limited (Subs. of Orion Corporation)
06.2017 - Current
- Oversee the life cycle management of assigned products [EU (Centralized, MRP, DCP, NP) and ROW].
- Preparation and submission of post approval changes to approved marketing authorizations including CMC Variations, Line extensions, Renewals, Art 61(3) notifications, pharmacovigilance related Referrals, variations to implement PSUSA assessment changes and response to RFI.
- Process improvement: Identify gap in existing process, design and establish streamline processes to enhance overall regulatory efficiency.
- Evaluated change controls and played a pivotal role in managing stock out situations effectively.
- Regulatory Database Maintenance (RIMS)
- Collaborated closely with partners to ensure compliant execution of organizational changes and maintaining a strong focus on regulatory conformance.
- Training and Onboarding: Train new joiners on internal guidelines, SOPs, and relevant regulatory requirements to ensure they are fully equipped to contribute to the regulatory process.
- Mentoring & Support: Offer ongoing mentoring and support to junior team members, helping them understand and apply regulatory procedures effectively in their roles.
- Handling the life cycle management of one of the most important portfolios (proprietary product) of Orion, i.e."Entacapone” family.
Senior Officer – Regulatory Affairs
Ajanta Pharma Private Limited
07.2014 - 05.2017
- Prepared dossiers in e-CTD format (Module 3) for WHO Prequalification Programme and Drug product part (Section 3.2.P.4, 3.2.P.5 and 3.2.P.7) for ANDA submission.
- Managed and executed post prequalification activities for WHO prequalified products. Response to WHO deficiencies.
- Prepared report of the regulatory issues to be presented to the regulatory manager.
- Reviewed quality documents, prepared tenders documents for WHO Prequalified Products.
- Co-ordination with cross-functional team for regulatory documents.
- Maintenance of regulatory database.
- Responded to additional questions received from authority.
Officer – Regulatory Affairs
Aurochem Laboratories (I) Pvt Ltd.
04.2012 - 06.2014
- Dossier review and compilation in ACTD format and filling tenders for ROW countries
- Co-ordination with factory personnel for arrangement of COA, samples, FPS, RMS, Process validation & Method Validation etc
- Identification & Rectification Errors in documents received from QA & QC
- Maintenance of dossiers related records
- Responsible for Checking of product Inserts for the product and follow up with art department for approval and finalizing it
Officer – Regulatory Affairs
BDH Industries Pvt Ltd.
11.2010 - 03.2012
- Obtained Marketing authorizations for generic brands by Planning, preparing, coordinating, submitting the applications & responding to deficiencies raised by relevant ROW health authorities
Education
B Pharm -
Mumbai University
01.2010
Skills
- Project management
- Regulatory compliance
- Regulatory submissions
- CMC writing
- Regulatory Information Management Systems
- Attention to detail
- Cross-functional teamwork
Hobbies and Interests
- Knitting
- Crocheting
Disclaimer
I, Pallavi Sawant, declare that the above given information is correct to the best of my knowledge.
Languages
- English
- Hindi
- Marathi
Personal Information
- Date of Birth: 07/22/87
- Nationality: Indian
- Marital Status: Married
Timeline
Manager – Global Regulatory Affairs
FinOrion Pharma India Private Limited (Subs. of Orion Corporation)
06.2017 - Current
Senior Officer – Regulatory Affairs
Ajanta Pharma Private Limited
07.2014 - 05.2017
Officer – Regulatory Affairs
Aurochem Laboratories (I) Pvt Ltd.
04.2012 - 06.2014
Officer – Regulatory Affairs
BDH Industries Pvt Ltd.
11.2010 - 03.2012
B Pharm -
Mumbai University
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