NIRUPMA PAL
Gurugram
Summary
Highly accomplished individual with excellence in pharmaceutical regulatory activities (regulatory filings and life cycle management). Professional experience of around nine years supporting international regulatory affairs, including the US, Canada, Europe, and most of the markets (Brazil, China, Russia, Korea etc.). Demonstrated success in managing DMFs, CEPs, ASMFs, and handling end-to-end CMC documentation. Well-versed in ICH and country-specific guidelines. Adept in stakeholder management across inter-departmental teams for data generation, as per regulatory agency recommendations and committed to achieving organizational goals through critical thinking and effective communication
Overview
9
9
years of professional experience
1
1
Certification
Work History
Deputy Manager (Regulatory Affairs, CMC)
Freyr Software Services Pvt. Ltd. (Global Regulatory Solutions and Services)
Hyderabad
05.2024 - Current
- Prepared submission strategies by identifying regulatory requirements and evaluating documentation needs for various regulatory authorities [EU, Brazil, Korea, Canada etc].
- Conducted assessments of change controls to ensure compliance with global regulations.
- Identified potential risks associated with assigned products and communicated findings effectively.
- Executed regulatory activities in alignment with global guidelines and defined strategies.
- Led authoring and review of CMC submission components for post-approval changes and health authority responses [EU, Korea, Brazil, etc].
- Collaborated with Takeda and external partners to maintain regulatory conformance during change management.
- Proposed mitigation strategies for identified regulatory risks
- Managed multiple priorities while maintaining focus on achieving business objectives.
Regulatory Affairs Associate II
Teva API India Private Limited (A subsidiary company of Teva Pharmaceutical Industries Limited)
Greater Noida
07.2020 - 04.2024
- Submitted the amendment and annual DMF reports to the US FDA on time.
- Prepared and submitted CEP, DMF, and ASMF to various regulatory authorities.
- Coordinated with multiple departments for timely document compliance and regulatory submissions.
- Responded promptly to deficiencies from customers and regulatory authorities.
- Developed DMFs for regulated markets, including Canada, the EU, Japan, Korea, Taiwan, Mexico, Russia, and China.
- Formulated submission strategies, prioritizing projects according to timelines.
- Reviewed CMC documents and provided regulatory assessments as needed.
- Maintained a regulatory database.
- Provided internal training w.r.t current regulatory guidelines within departments.
- eCTD publishing of DMFs for various regulatory agencies (FDA, EMEA, EDQM, and Health Canada, etc.)
- Hands-on experience with eCTD submission.
- Experienced in Form 40 application for Drug Substance Registration Certificate to CDSCO.
- Timely submission of post-approval application and response to deficiency for drug substance registration to CDSCO.
- Coaching new joiners in areas of regulatory submission and documentation.
Executive
Ind-Swift Laboratories Limited
Chandigarh
07.2018 - 06.2020
- Prepared, compiled, and reviewed DMFs for in-house APIs for submission to regulatory authorities worldwide (US, EDQM/Europe, Australia, Canada, and emerging markets).
- Handled queries from various regulatory agencies and clients.
- Managed life cycle updates, renewals, and amendments for ANDA/MAAs submissions.
- Collaborated with cross-functional teams to ensure API development met global regulatory standards.
- Providing regulatory support to the Procurement team by reviewing technical packages, open parts of outsourced intermediates, and APIs for regulatory adequacy.
- Ensured regulatory compliance by assisting with change control approvals and regulatory inspections (FDA, US, Australia, Canada, EU, etc.) and maintaining Regulatory database.
- Sharing technical information to API customers (Open Part of DMFs/Technical Data Package) for development of API business.
Executive
Sun Pharmaceutical Industries Limited
Gurugram
02.2016 - 07.2018
- Responsible for the preparation, compilation, and review of DMF for in-house manufactured APIs for submission to various regulatory authorities (US, EDQM/Europe, Australia, Canada, and emerging markets) to support ANDA/MAAs.
- Handling queries obtained from different regulatory agencies and customers.
- Ensuring life cycle management (updates/renewals, annual reports, amendments) for submission to various regulatory authorities.
- Providing regulatory support to the Procurement team by reviewing technical packages, open parts of outsourced intermediates, and APIs for regulatory adequacy.
- Supporting chemical manufacturing and quality assurance to ensure regulatory compliance by assisting with change control approvals and regulatory inspections (FDA-US, Australia, Canada, EU, etc.).
- Sharing technical information with API customers (Open Part of DMFs/Technical Data Package) for the development of the API business.
- Understanding pharmacopoeias and ensuring compliance of products with the latest editions.
- Provide internal training with respect to current regulatory guidelines within departments.
- Evaluating post-approval changes as per the regulatory guidelines, ensuring repositions of the regulatory database, and compliance with departmental guidelines.
- Ensuring the repositioning of the regulatory database and compliance with departmental guidelines.
Education
Master of science - Organic Chemistry
Ramjas College
Ramjas College01-2015
Bachelor of science - Chemistry
ARSD College
Delhi01.2013
Skills
- Critical thinking and interpersonal skills
- Customer relationship management
- Committed to achieving organizational goals
- Communication skills
- MS Excel and MS PowerPoint
- eCTD publishing
- Critical thinking and interpersonal skills
- Customer relationship management
- Committed to achieving organizational goals
- Communication skills
- MS Excel and MS PowerPoint
- eCTD publishing
Certification
- Certificate course on “Validation and Transfer of Analytical Methods for Pharmaceutical Analysis”.
- Certificate course in “Hands on Training on PharmaReady Software”.
Languages
English & Hindi
Hobbies and Interests
Participated in marathons, hiking, trekking, and traveling
Passionate about continuous learning and leadership development
Skills
eCTD publishing
Veeva Vault RIM system
Trackwise
Docubridge
CESP portal
pharmaREADY
Global Insight
DCM
Sugam portal
Lorez validator
STRENGTH
- To work with a positive attitude to contribute to the healthy functioning of the organization
- Self-confident and great patience
- analyzing every angle of a project before working on it
- Adaptability to a changing environment
Timeline
Deputy Manager (Regulatory Affairs, CMC)
Freyr Software Services Pvt. Ltd. (Global Regulatory Solutions and Services)
05.2024 - Current
Regulatory Affairs Associate II
Teva API India Private Limited (A subsidiary company of Teva Pharmaceutical Industries Limited)
07.2020 - 04.2024
Executive
Ind-Swift Laboratories Limited
07.2018 - 06.2020
Executive
Sun Pharmaceutical Industries Limited
02.2016 - 07.2018
Master of science - Organic Chemistry
Ramjas College
Bachelor of science - Chemistry
ARSD College
Similar Profiles
Jaiprakash BhelondeJaiprakash Bhelonde
Deputy General Manager & Head, Non-Clinical / Toxicology Services at Freyr Global Regulatory Solutions & ServicesDeputy General Manager & Head, Non-Clinical / Toxicology Services at Freyr Global Regulatory Solutions & Services
ANUKRITI JAINANUKRITI JAIN
Senior Associate at Freyr Global Regulatory Solutions and ServicesSenior Associate at Freyr Global Regulatory Solutions and Services
Abhignya MuddapuramAbhignya Muddapuram
Technical Recruiter at Freyr Software Services Pvt LtdTechnical Recruiter at Freyr Software Services Pvt Ltd
Ashish ChandraAshish Chandra
Commercial Order Creation Manager at Orange BusinessCommercial Order Creation Manager at Orange Business
Megha TanwarMegha Tanwar
HR Manager at Varank Tech Private Limited (Formerly Verchaska Infotech)HR Manager at Varank Tech Private Limited (Formerly Verchaska Infotech)