SAKSHI GUPTA
London
Summary
Regulatory Affairs professional with 14+ years of experience in biologics and biosimilars, leading regulatory strategy, dossier preparation, submissions, health authority interactions, post-approval lifecycle management and regulatory intelligence across Europe and global markets. Experienced in EMA MAA submissions, variations, lifecycle activities, cross-functional regulatory guidance and submission readiness.
Over fourteen years providing conceptual leadership for the preparation/coordination of submission dossier according to regulatory requirements of Regulated and and Emerging markets. Formulate, lead and drive global regulatory strategy and health authority interactions for biosimilars for EMA and FDA. Managing the Product life cycle management from development phase to commercialization along with the management of the post approval variation of the products. Competencies for Biologics (Biosimilars): MAA submission, CTA submission, Scientific Advice preparation and biosimilar product development.
Overview
19
19
years of professional experience
Work History
Manager
Polpharma Biologics
London
2022.01 - Current
- Lead preparation of dossier submission for MAA in EMA, US-FDA and in Primary territories (UK, CH, AU) and Global Rest of the World.
- Drive dossier review including regulatory strategy till approval withing shortest possible timeframe.
- Supported regulatory intelligence evaluation, monitoring reference product, evaluating data bases, guidelines.
- Lead the timely preparation of responses to questions from health authorities.
- Provide regulatory guidance to projects teams on aspects of clinical and non-clinical development.
- Lead the preparation and take part in health authority meetings (e.g. scientific advice and pre-submission meetings).
- Represents Regulatory team in interdisciplinary project teams; partner with Clinical Research & Development, Quality and Technical Research & Development.
- Monitor changes in regulatory guidelines, activities of competitor programs and updates in the labelling of originator products based on data base searches.
- Identify regulatory trends impacting biosimilar development.
- Build proficiency in regulatory publishing software and electronic submission formats (e.g., eCTD), contributing to dossier assembly and submission readiness.
- Work with cross-functional stakeholders to ensure alignment on documentation standards, timelines, and regulatory expectations.
Senior Manager
Mylan Pharmaceuticals Pvt Ltd
2016.09 - 2021.10
- Submission of biosimilars MAA in Emerging and Major Market like TGA, MedSafe, ANVISA, NMPA, ANMAT, INVIMA and COFEPRIS.
- Interacting with cross functional teams of SMEs to finalize the CMC sections of the dossier.
- Managing post approval change control assessment, variation classification and authoring post approval change packages for assigned biological products.
- Trained in CMS and Artwork modules of Trackwise, also comprehensive experience in eCTD publishing.
- Preparation and/or review of regulatory query responses for various submission in regulated and RoW countries.
- Prepare and refine regulatory documents to meet agency submission standards and internal quality benchmarks.
- Coordinate the organization and lifecycle management of key regulatory assets, including electronic submissions, correspondence logs, and approval archives.
- Co-ordination with CFTs for timely completion of regulatory submissions.
- (Biosimilars)
Manager
INTAS PHARMACEUTICALS
2014.06 - 2016.08
- Ensure timely preparation, review, verification, authentication, authorization and submission of applications and documents in compliance with regulatory requirements for Indian and Emerging markets.
- Ensure timely handling of queries raised by regulatory agencies and clients.
- To participate in product development strategies making for ensuring compliance to regulatory authorities.
- Responsible for regulatory filing for Indian market including RCGM, CTA and MAA applications and handling query response for the same.
- Involved in defining submission strategy based on statutory requirements laid by the competent authorities.
- Involved in clinical trial operational regulatory compliance and review of documents.
- Assess change controls and deviations and take necessary actions arising from the change management system in subsequent submissions.
- (BIOPHARMA DIVISION)
Senior Executive
CADILA PHARMACEUTICALS LTD
2013.02 - 2014.06
- Collection of various technical and administrative documents required for preparation of ANDA (DMF, Spec. STP, BMR, CoA etc.).
- Review the technical and administrative documents with respect to the requirements of USFDA & other guidelines.
- Preparation of write-up as per guidance and review the same.
- Preparation of ANDAs in prescribed format (eCTD) and review the same.
- Receipt and redress of queries from internal as well as from external sources.
- Archiving of submitted ANDAs and its subsequent applications.
- Prepare and review of original and subsequent submissions of other applications in US Market including IND and etc.
- Compilation of product label via Structured Product labeling (SPL).
Associate Scientist
LUPIN LIMITED
2010.08 - 2013.01
- Review, author and collation of regulatory dossiers and obtaining approval from DBT, DCG(I), CDSCO, SLAs of various licenses, certificates and NOCs required in product life cycle management.
- Active role in coordinating with all departments during audits and inspections.
- Assist in organizing IBSC meetings as and planning for timely submission of applications to RCGM.
- Review, preparation and submission of biosimilar applications to RCGM (Department of Biotechnology, Govt. of India) for obtaining permission for initiating non-clinical toxicological studies. (Form C3, Form C5, Form B1 and Form B3 etc.)
- (BIOTECH DIVISION)
Executive
RELIANCE LIFE SCIENCES PVT LTD
2007.05 - 2010.08
- Preparation and review of Registration dossier for recombinant DNA products as per ICH CTD format and ACTD format for ROW, Semi regulated markets and response to queries raised by Ministry of Health (MoH).
- Drug Master File for US FDA filing.
- Clinical Trial Application and New Drug application for biologics as per CDSCO guidance documents.
- Review and collation of data received from QA, Process Development & Packaging; as per regulatory requirements & as required in response to queries raised by MoH.
- Notification of post approval changes to DCGI as per CDSCO guidance document.
- ECTD, Paper Publishing Module (PPM), Structured Product labeling (SPL) and Mock eCTD submissions to USFDA.
Education
Young Clinical Professional Program -
Reliance Life sciences
2008-05
Certificate course - Advance analytical chemistry
IIT-Kanpur
2006-03
M.Sc. - Biochemistry
CSJM University
Kanpur2005-01
B.Sc. - Biological sciences
CSJM University
Kanpur2002-01
Skills
- Strong management skills
- Leadership abilities
- Team player
- Excellent communication skills
- Interpersonal relationships
- Regulatory compliance
- Regulatory and registration plans
- ECTD
Custom
Young Clinical Professional Program, Reliance Life Sciences, 2007-05-01, 2008-05-01, M.Sc. in Biochemistry, CSJM University, Kanpur, 2005, First Division, B.Sc. in Biological Sciences, CSJM University, Kanpur, 2002, First Division, Basic operating systems, MS Office, MS PowerPoint, MS Excel, Internet applications, Advance Analytical Chemistry, IIT-Kanpur, 2006-01-01, 2006-03-01
Timeline
Manager
Polpharma Biologics
2022.01 - Current
Senior Manager
Mylan Pharmaceuticals Pvt Ltd
2016.09 - 2021.10
Manager
INTAS PHARMACEUTICALS
2014.06 - 2016.08
Senior Executive
CADILA PHARMACEUTICALS LTD
2013.02 - 2014.06
Associate Scientist
LUPIN LIMITED
2010.08 - 2013.01
Executive
RELIANCE LIFE SCIENCES PVT LTD
2007.05 - 2010.08
Young Clinical Professional Program -
Reliance Life sciences
Certificate course - Advance analytical chemistry
IIT-Kanpur
M.Sc. - Biochemistry
CSJM University
B.Sc. - Biological sciences
CSJM University