Summary
Overview
Work History
Education
Skills
Websites
Publications and presentations
Trainings and Workshops
Accomplishments
Certification
References
Timeline
Volunteer

Shabana N

Hyderabad

Summary

Pharmaceutical professional offering ~20 years of experience in multifarious domains: formulation development, clinical pharmacology, regulatory submissions, project leadership, and coaching/mentoring. Extensive experience in regulatory submissions/interactions, including global dossiers, preparations for Health Authority interactions, and response to questions. Leadership experience as both direct line manager, and leading without authority. Committed to delivering to organizational vision and mission with high quality and on time.

Overview

23
23
years of professional experience
1
1
Certification

Work History

Senior Expert Regulatory Writer

NOVARTIS HEALTHCARE PVT. LTD.
Hyderabad
10.2012 - Current

This role requires extensive skills in building project strategy, stakeholder management, including senior leadership and Global Program Teams (GPT), leadership skills, and a commitment to delivering quality on time.

  • Program Writer: Program-wide coordination with GPT/Clinical Trial Teams (CTT) for regulatory writing resource allocation, dossier submission strategy and document guidance. Point of contact for Regulatory Writing for assigned program.
  • Lead Writer: Lead Regulatory Writing team to execute timely and high-quality submission documents. Participate in strategy discussions, and project planning in Submission Team. Support preparations for Health Authority interactions.
  • Capability building: Lead and/or coordinate training sessions for regulatory writers at the departmental-, site-, global-, and cross-organizational levels. Coach or mentor regulatory writers.
  • Cross-functional collaboration: Develop and maintain productive relationships with stakeholder teams.
  • Regulatory document template management: To align with updates in regulatory expectations.
  • Compliance: Contribute to SOPs, WPs, and departmental guidance. Maintain audit, SOP, and training compliance.
  • Conduct peer review of documents.

Senior Research Scientist

Ranbaxy Laboratories Limited
Gurgaon
12.2006 - 09.2012

Oversaw daily operations for a team of four, including work assignments and budget management in the generic medicines setup. Combined operational leadership with functional expertise to optimize team performance.

  • Team management: Conducted performance appraisals to drive productivity and employee development.
  • Response to global Health Authority questions: Preparing responses for defending regulatory dossiers, orchestrating cross-departmental coordination for timely and complete responses.
  • Pharmacokinetic analyses: To support Bioavailability/Bioequivalence trial results' reporting and regulatory submissions.
  • Regulatory inspections and internal audits
  • Study protocols and reports

Project Associate

Dabur Research Foundation
Ghaziabad
02.2002 - 01.2004
  • Pharmaceutical laboratory operations: Gained an understanding of pharmaceutical product development and the routine functions of an advanced pharmaceutical laboratory, including CAPEX, and vendor management.
  • Novel Drug Delivery System: Developed a prototype for oncology drugs.
  • Pre-formulation studies: For product testing and stability studies for new formulations.

Education

Ph.D. - PHARMACEUTICAL MEDICINE

HAMDARD UNIVERSITY
NEW DELHI, INDIA
01.2007

MASTERS - PHARMACY (PHARMACEUTICS)

HAMDARD UNIVERSITY
NEW DELHI, INDIA
01.2001

Skills

  • Regulatory writing
  • Project management
  • Submission strategy
  • Team leadership
  • Capability building
  • Coaching and mentoring
  • Cross-functional collaboration
  • Document management systems: CREDI/REDI, Veeva Vault, Subway, ARONDA
  • Phoenix WinNonlin
  • Bioequivalence/Bioavailability trials
  • Bio-analytical techniques

Publications and presentations

  • Establishing Bioequivalence of Racemic Venlafaxine Formulations using Stereoselective Assay Method: Is It Necessary?, Chirality, 2011, 23, 10, 948-954
  • Atorvastatin and Metformin: A Pharmacokinetic Comparison of Fixed Dose Combination versus Individual Formulations, Clinical Drug Investigations, 2011, 31, 12, 853-863
  • Regulatory Recommendations for Clopidogrel – Focus on Validation of a Reliable Bioanalytical Method and its Application to a Bioequivalence Study, Clinical Research and Regulatory Affairs, 2011, 28, 4, 87-95

Trainings and Workshops

  • High Impact Virtual Team Member, 2012
  • Training for Subject Matter Expert Boot-camp and Facilitations Skills, 2013
  • Communicating and Influencing, 2013
  • Executive Education Program in Biostatistics, 2013
  • GCP in Action, 2014
  • Basic Regulatory Affairs Course, 2015
  • Accelerated Development Program for Women Leaders, 2016
  • Data Integrity and Data Mapping, 2016 and 2017
  • Management Training Program, 2020
  • Mini-rotation with Pharmacometrics team, 2022
  • Mini-rotation with Regulatory Affairs team, 2024-25
  • Training on financial aspects of drug development, 2025

Accomplishments

  • Keen eye for business opportunities: Departmental portfolio expansion and strategy for sustained productivity via training programs and stakeholder interactions.
  • Recognized as a subject matter expert since June 2014
  • Leading and/or coordinating departmental training activities since 2013

Rewards:

  • Nomination for the Appreciate Award at Ranbaxy Research Laboratories, 2011
  • “Vision “award at Novartis: September 2014
  • “Passion, Quality and Speed” awards at Novartis: two in 2015, and one in 2016
  • “Above and Beyond” awards at Novartis: four in 2017 and one in 2018
  • “Spark” awards at Novartis: eleven in 2019, eight in 2020, ten in 2021, ten in 2022, twelve each in 2023 and 2024

Certification

Certara certified NCA analyst using Phoenix WinNonlin

References

References available upon request.

Timeline

Senior Expert Regulatory Writer

NOVARTIS HEALTHCARE PVT. LTD.
10.2012 - Current

Senior Research Scientist

Ranbaxy Laboratories Limited
12.2006 - 09.2012

Project Associate

Dabur Research Foundation
02.2002 - 01.2004

Ph.D. - PHARMACEUTICAL MEDICINE

HAMDARD UNIVERSITY

MASTERS - PHARMACY (PHARMACEUTICS)

HAMDARD UNIVERSITY

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