Hi, I’m
Saumya Chauhan
Gr.Noida,Uttar Pradesh
Summary
Experienced bio-similar , medical devices and drug regulatory affairs professional with a decade of success in the pharmaceutical industry. Demonstrated expertise in providing strategic regulatory guidance and support throughout the product lifecycle. Adept at ensuring compliance, leading teams, and implementing effective plans. Empowers employees to independently handle daily functions and meet customer needs efficiently. Recognized as a diligent trainer and mentor with exceptional management abilities. Thrives as a collaborative leader, skilled at building and maintaining relationships with diverse stakeholders in dynamic and fast-paced environments.
Overview
12
years of professional experience
1
Certification
Work History
Viatris Pharmaceuticals LimitedHyderabad, India
Manager
08.2022 - Current
Job overview
- Company Overview: Upjohn division
- Develop and implement regulatory strategies for biosimilars, drugs, and devices
- Prepare and submit regulatory dossiers (IND, NDA, ANDA, BLA, CE mark, 510(k), PMA, etc.)
- Ensure compliance with global regulatory requirements (FDA, EMA, MHRA, etc.)
- Manage regulatory timelines, project plans, and submission schedules
- Worked collaboratively within Regulatory and cross-functionally with key stakeholders including Commercial, Supply Chain, Quality, Medical, Drug Safety, Operations and Technical teams to ensure alignment on goals, objectives, priority /timelines for any regulatory submission / approval / implementation in line with stock requirements
- Delivered milestones to enable approvals/launches for key products in accordance with agreed strategy and timelines
- Met defined submission goals for all assigned post-approval changes, and lifecycle maintenance and compliance submissions, delivered business commitments, ensuring business continuity, delivered maintenance and compliance activities, demonstrated creative regulatory strategies and excellence in execution and quality
- Contributed to creating a supportive learning environment to enhance knowledge & skills building
- Assisted with development of training materials and SOPs
- Upjohn division
Pfizer Healthcare India Private LimitedChennai, India
Deputy Manager
06.2021 - 08.2022
Sun Pharmaceutical Industries Ltd.Gurgaon, India
Research Manager
11.2014 - 05.2021
Job overview
- Supported in developing and executing the overall regulatory CMC strategies for non-orals/orals for global markets
- Prepared, reviewed, compiled and timely submitted Dossiers (module 1-module 5) for all USA(505(j), 505(b)(2), EU/ANZ markets as per current regulatory requirements, eCTD submission
- Ensured timely response to deficiencies received from regulatory agencies to secure approval
- Lifecycle management of filed / approved dossiers through Renewal/Reregistration/Variation filings
- Assured accuracy, compliance, consistency and adequacy of all submission documents in line with current regulatory requirements and expectations
- Provided strategic, tactical, and operational direction and guidance for underdevelopment product and key regulatory milestones from product development, through filing to pre- and post approval activities
- Acted as a regulatory subject matter expert through cross functional collaboration with R&D, Project Management, Commercial Team and other relevant stake holders to ensure regulatory compliance
- Ensured business continuity, Pharmacopoeial, ICH Q3D, nitrosamine compliance
- Conducted department level training and learning sessions, as necessary, to educate regulatory strategists and other roles in the department on regulatory requirements, policies, and procedures
- Ensuring appropriate individual and team development and recognition
Mylan Laboratories limitedHyderabad, India
Trainee
01.2014 - 05.2014
Job overview
- Title: Development and Validation of Stability indicating assay method for estimation of Antihypertensive finished dosage form by RP-HPLC
- Supervisor: Mr. Durvasnarayan Patil, Associate Vice President, Mylan R&D Bollaram, Hyderabad
- Summary: The aim of the project was to develop a simple Stability indicating assay method (SIAM) which detect and quantify drug in tablet formulation without any interference with impurities
Education
BITS Pilani
MBA from Hospital And Healthcare Management
06.2021
University Overview
GPA: 7.85 (CGPA)
BITS Pilani
M.PHARM
01.2014
University Overview
GPA: 7.9 (CGPA)
KSOP
B. PHARM
01.2012
University Overview
GPA: 79%
BBL Public School
AISSCE from Class XII
07.2007
University Overview
GPA: 82.4%
GRM Public School
AISCE from Class X
06.2005
University Overview
GPA: 87.8%
Skills
- Effective Communication
- Strategic planning
- Strong Interpersonal Skills
- Eager to Embrace Opportunities
- Active Listening
Certification
- Pharmaceutical and Medical Device Innovations, University of Minnesota, 2024-11-01
- Project Planning: Putting it all Together, Google, 2024-01-02
- Medical device regulation 2017/45 EU Regulatory Affairs, Udemy, 2023-07-01
- Medical Device Regulations, Udemy, 2023-08-01
- Project Initiation: Starting a Successful Project, Google, 2023-05-01
- Foundations of Project Management, Google, 2022-07-01
- FDA training on Generic Drugs overview & Introduction to FDA Human Drug Review and Approval Basics, Date not specified
Languages
Hindi
English
Extra-Curricular Activities
Participated to help create Guinness World Records for the largest human image of an organ organized by Ranbaxy Laboratories Ltd & APICON, 2015-02-20, Gurgaon, India Executive Member of Tagore Art and Cultural Committee, 2010-2011, Ghaziabad, India Second Prize in scientific poster presentation on 'Chronopharmacotherapeutic drug delivery of diclofenac sodium', 2011-03-12, New Delhi, India Won second prize in quiz competition held by 'CABALLEROS', 2009-10-06, Ghaziabad, India Volunteer in Indian Pharmaceutical Association conference, 2010-11-14 Attended IHPA & IIMT National conference by IIMT and presented paper on floating drug delivery system Participated in Ranbaxy Dance competition and won prize
Systems Handled
- RIMS
- PDM
- D2
- Docubridge
- Rosetta Phoenix
- RRM
- SPA
- DCM
- Trackwise
- CST
- EVMPD register
- DD Solver
- Citrix
Personal Information
Title: Regulatory affairs manager
Disclaimer
I, Saumya Singh Chauhan, solemnly declare that the information given above are all true to the best of my knowledge and belief.
Timeline
Manager
Viatris Pharmaceuticals Limited
08.2022 - Current
Deputy Manager
Pfizer Healthcare India Private Limited
06.2021 - 08.2022
Research Manager
Sun Pharmaceutical Industries Ltd.
11.2014 - 05.2021
Trainee
Mylan Laboratories limited
01.2014 - 05.2014
BITS Pilani
MBA from Hospital And Healthcare Management
BITS Pilani
M.PHARM
KSOP
B. PHARM
BBL Public School
AISSCE from Class XII
GRM Public School
AISCE from Class X