Bindu Jadeja
Bangalore
Summary
Accomplished regulatory affairs leader with extensive experience, excelling in strategic planning and stakeholder management. Proven track record in driving global submission strategies and mitigating regulatory risks. Adept at cross-functional collaboration and team mentorship, enhancing program management efficiency. Skilled in health authority engagement and problem-solving.
Overview
19
19
years of professional experience
1
1
Certification
Work History
International Associate Regulatory Affairs Director
AstraZeneca
Bangalore
02.2025 - Current
- Led global planning of submissions, ensuring timely delivery to international markets.
- Communicated submission plans and updates to iRAMS and iCMC, impacting priorities effectively.
- Drove international submission planning with feedback loops to IRAM leadership and GRET.
- Identified regulatory risks, implementing mitigation strategies with input from iRAD.
- Allocated iRAM resources within iRT, guided by iRAM management insights.
- Coordinated submission kickoff meetings for international markets as necessary.
- Updated RSST on submission plans and progress, ensuring alignment with goals.
- Managed regulatory oversight for HA filings and interactions with iRAD.
Senior Global Program Regulatory Manager
Novartis
Hyderabad
09.2024 - 01.2025
- Provided strategic input to global regulatory strategy, enhancing innovative approaches and leadership.
- Coordinated regulatory readiness across functions and regions, representing RA in cross-functional activities.
- Contributed to development and maintenance of key documents, including safety documents and labeling.
- Determined requirements and coordinated health authority interactions for streamlined communication.
- Led planning, preparation, and submission of clinical trials aligned with global registration strategy.
- Oversaw initial registrations and post-approval applications, ensuring accuracy in local product information.
- Ensured timely submission of compliance reports while maintaining regulatory information in databases.
- Served as subject matter expert in RA, mentoring team members on best practices.
Global Program Regulatory Manager
Novartis
Hyderabad
02.2020 - 08.2024
- Regulatory Strategy-implementing regulatory strategy and managing operational activities for assigned regions, working with RA GPT representative and/ or GTAL to plan and facilitate presentations to organizational regulatory boards on regulatory strategy, coordinating and implementing regulatory readiness with other line functions, country organizations and key opinion leaders.
- HA Interactions-serving as local HA liaison, timely response to HA requests/responses.
- Submissions and Approvals-coordinating, planning and preparing for variation submission of dossiers in assigned regions, review of global dossier summary.
- Prescribing Information-contributing to the update of the CDS with RA GPT and/or GTAL consistent with development data and commercial objectives, assisting with generation of local Pls and ensuring they are integrated with the CDS, revising labels as needed to achieve HA approval with the best possible label based on available data, ensuring necessary updates or required reviews of local labeling and to capture deviations to maintain alignment with the CDS.
- Regional Excellence and Compliance-on time submission of annual reports and renewals across assigned regions, ensuring quality and compliance with global regulatory requirements and adherence to regulatory internal policies and processes.
Regulatory Affairs Manager
IQVIA
04.2018 - 01.2020
- As Project Lead: Worked on Asset divestment program as Data transfer lead, maintain and monitor the knowledge transfer and keep complete and accurate logs that document which documents have to and been transferred and accepted to and by the buyer including redaction of information as a part of scope of the deal.
- Manage resourcing and Financial aspects of the project including change in scope contracts.
- Responsible for coordination of the process and to monitor progress and produce metrics and KPIs Leading regular internal and external meetings with stakeholders.
- Responsible for strategy implementation and operational aspects In line with client strategy.
- Proactively identify or foresee Issues and propose and Implement remedial actions and plan in alignment with the client.
- Communication to client for the resourcing with respect to absences, back up plan, newcomers, any disruptive event or risk.
- Supporting the resource allocation with the Submission Leads: allocate resources as per the clinical study transition planning.
- Training and onboarding/offboarding Coordinating the knowledge sharing with the Submission Leads Oversight Projects Gathering approval request for clinical study transition postponing.
Senior Regulatory Affairs Officer
IQVIA
04.2016 - 03.2018
- Prepared labelling Variation Package for assigned products (EMA).
- Conducted literature searches to update SmPC.
- Developed justification tables for effective implementation of CCDS updates into local labelling.
- Implemented CCDS updates in local labelling documents (SPC and PL).
- Reviewed Labelling Clinical Overview (LCOV) Addendum and clinical overview summary.
- Coordinated translations of labelling documents into local languages.
- Managed product registration and MAA for Asia-Pac region.
- Developed regulatory-specific training manuals and slide decks, ensuring compliance with client requirements.
Regulatory and Start-up Specialist
IQVIA
04.2012 - 03.2016
- Regional Asia-Pac Lead for projects or service line.
- Lead RSU team or service line members in all designated activities.
- Lead RSU team by providing operational strategy and parameters for Ethics Committee submissions and regulatory documents.
- Monitor team efficiency and adherence to project timelines.
- Ensure adherence to standard operating procedures (SOPs) and work instructions (Wis) and quality of designated deliverables.
- Maintain and manage RSU data tracking entries in database.
- Review for completeness and accuracy.
- Work with sponsors and Internal team members to establish regulatory requirements and contracts necessary for startup.
- Work with regulatory team members or sponsor to secure authorization of regulatory documents.
- Work with legal team members or sponsor to secure authorization of contracts.
- Work with Clinical Operations, Project Management and Site Identification on RSU project specific status and deliverables.
- Where applicable, provide work instructions to team members in preparation of regulatory submissions.
- May translate or review completed translations of critical documents.
- May participate in feasibility and/or site identification activities.
Regulatory Affairs Officer
IQVIA
10.2008 - 03.2012
- Development of Regulatory strategy for clinical trial application to Health Authority.
- Confirms completeness of the regulatory dossier for submission to HA.
- Review of study related documents including Protocol, Investigators Brochure, pre-dinical and clinical study reports.
- Assessment of the adequacy of data for preparation of dossiers.
- Liaison with the study team (Local & Global) and study Sponsor to obtain additional study related documents.
- Labeling review.
- Registration and maintenance of clinical trials on the http://ctrl.nic.in.
- To perform Feasibility Analysis.
- Keeping abreast of developments of regulatory policy for clinical research both in India and overseas.
- To prepare and review departmental SOPs.
- Work with sponsors and internal team members to establish regulatory requirements and contracts necessary for startup.
- Liaises with the study team (Local & Global) and study Sponsor to obtain additional study related documents.
- Responsible for processing safety information received from sites/sponsor and reporting these events to DCG (I) and appropriate personnel within the stipulated time frame.
- Generation of monthly status report on regulatory safety reporting.
- Project-wise tracking of safety reports and forwarding to the sponsor if required.
- To respond to queries from regulatory authorities appropriately and promptly (within 2 days of receipt of required information from study team/sponsor).
Regulatory Affairs Associate
Intas Pharma
03.2007 - 10.2008
- Confirming completeness of the regulatory dossier for submission to EU, ANZ and other Semi-regulated markets.
- Review of study related documents including Protocol, Investigators Brochure, preparation and review of EC submission documents, pre-clinical and clinical study reports.
- Preparation of the summaries of relevant information for regulatory dossier for Non-clinical and Clinical Summaries in CTD.
- Assessment of the adequacy of data for preparation of dossiers.
- Searches the Internet for obtaining relevant literatures.
- To respond to queries from regulatory authorities appropriately and promptly.
Education
Post Graduate Diploma in Business Management - International Business Management
NMIMS
Mumbai01-2015
M.Pharm - Pharmacology
L.M. College of Pharmacy
Ahmedabad, Gujarat06.2006
B.Pharm -
K.B. Institute of Pharmaceutical Education and Research
Gandhinagar03.2004
Skills
- Stakeholder management
- Health authority engagement
- Regulatory strategy development
- Cross-functional collaboration
- Project leadership
- Team mentorship
- Problem solving
- Strategic planning
- Program management
- Risk assessment
- Analytical skills
- Time management
- Collaboration and communication
Affiliations
- Gujarat State Pharmacy Council
- Indian Pharmacological Society
- Indian Society of Clinical Research
Certification
PGDBM, NMIMS, Mumbai, 01/2014 - 12/2015
Accomplishments
- GATE Qualification, 02/2004 - 06/2004, 96.41 Percentile, All India Rank 301
- Received several WWD (Work Worth Doing) awards at IQVIA
- Received several SPARK points for leadership, mentoring and quality of the deliverables at Novartis
Languages
- English, Full Professional Proficiency
- Hindi, Native or Bilingual Proficiency
- Gujarati, Native or Bilingual Proficiency
Publications
Poster on 'Poly-Pharmacy', Fifth annual conference of Society of Pharmacovigilance (India), 11/11/2005 - 11/13/2005, Ahmedabad
Projects
Effects of Tacrolimus and Ormeloxifene on Spinal cord Injury model of rats, 12/2005 - 07/2005, Under the guidance of Dr. R.V.Bhatt and co-guide Dr. Deepa Joshi at Torrent Research Centre. Sub-acute toxicity study of Diclofenac HCl 20mg+Diclofenac Sodium 50mg/ml injection, 05/2004 - 03/2005, Under the guidance of Dr. R.K.Goyal and Dr. D.D.Santani at L.M.College of Pharmacy.
Personal Information
Nationality: Indian
Conferences Courses
- Global Pharma Regulatory Summit (GPRS)-2021, Conference/issuer of the certificate
- GPRS-2017, Mumbai, Conference/Issuer of the certificate
- DIA-workshop on eCTD-2014, Conference/Issuer of the certificate
- Workshop On 'Global Perspective And Overview Of CTD To e-CTD', 04/07/2011, Conference/Issuer of the certificate
- Workshop on 'Networking for Enhanced Collaboration', 09/22/2010, Conference/Issuer of the certificate
- Workshop on 'Adapting to Change', 07/15/2009, Conference/Issuer of the certificate
- Workshop on 'Personal Effectiveness', 07/09/2009, Conference/Issuer of the certificate
- ICMR sponsored workshop on 'Clinical Research and Regulatory Affairs', 2008, Conference/Issuer of the certificate
- Annual Conference of Indian Pharmacological Society, 12/21/2006 - 12/23/2006, Conference/Issuer of the certificate
- Annual Conference of Indian Pharmacological Society, 12/28/2005 - 12/30/2005, Conference/Issuer of the certificate
Timeline
International Associate Regulatory Affairs Director
AstraZeneca
02.2025 - Current
Senior Global Program Regulatory Manager
Novartis
09.2024 - 01.2025
Global Program Regulatory Manager
Novartis
02.2020 - 08.2024
Regulatory Affairs Manager
IQVIA
04.2018 - 01.2020
Senior Regulatory Affairs Officer
IQVIA
04.2016 - 03.2018
Regulatory and Start-up Specialist
IQVIA
04.2012 - 03.2016
Regulatory Affairs Officer
IQVIA
10.2008 - 03.2012
Regulatory Affairs Associate
Intas Pharma
03.2007 - 10.2008
Post Graduate Diploma in Business Management - International Business Management
NMIMS
M.Pharm - Pharmacology
L.M. College of Pharmacy
B.Pharm -
K.B. Institute of Pharmaceutical Education and Research