Open to opportunities

Madhuri Jain

@madhurijain

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Experienced regulatory affairs professional with a focus on compliance.

India

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What I'm looking for

I am looking for a role that offers opportunities for growth and challenges in regulatory affairs, where I can leverage my expertise to contribute to innovative pharmaceutical solutions.

I am a dedicated regulatory affairs professional with extensive experience in the pharmaceutical industry, specializing in regulatory compliance and submission preparation. Currently, I serve as a Senior Executive in Regulatory Affairs at FinOrion Pharma India Pvt. Ltd., where I lead the preparation and review of regulatory documentation for product approvals in the European market. My role involves developing regulatory strategies, ensuring compliance with international standards, and mentoring junior associates.

Previously, I held positions at Janssen-Cilag and DDREG, where I managed lifecycle maintenance and post-approval applications, ensuring readiness for audits and compliance with regulatory processes. My background includes a strong foundation in CMC writing and project management, enabling me to effectively navigate complex regulatory landscapes and deliver high-quality submissions.

Experience

Work history, roles, and key accomplishments

Current

Senior Executive Regulatory Affairs

Current

FinOrion Pharma India Pvt. Ltd.

Nov 2022 - Present (2 years 6 months)

Responsible for the preparation and review of regulatory documentation for product approvals in the European market. Develops regulatory strategies for new products, ensures compliance with international standards, and mentors junior associates. Manages lifecycle activities and coordinates regulatory tasks to ensure timely submissions.

Regulatory Compliance Project Management Risk Assessment Documentation Management Regulatory Strategy Team Leadership

Regulatory Affairs Officer

Janssen-Cilag / ProductLife Group

Nov 2021 - Nov 2022 (1 year)

Managed lifecycle maintenance for UK and IE products, preparing and submitting post-approval documentation. Ensured compliance for audits and assisted with license applications while leading issue resolution for regulatory risks.

Regulatory Compliance Audit Risk Management Regulatory Strategy Lifecycle Management

Regulatory Affairs Officer

DDREG

Jun 2021 - Oct 2021 (4 months)

Assisted in developing high-quality regulatory dossiers and managed deficiency responses from authorities. Coordinated with stakeholders for documentation and ensured compliance with FDA guidelines for annual reports.

Dossier Regulatory Compliance Deficiency Response Management FDA

Regulatory Affairs Executive

Archerchem Healthcare Private Ltd.

Jan 2020 - Jun 2021 (1 year 5 months)

Prepared regulatory submissions in accordance with FDA regulations, managed electronic regulatory media, and ensured quality of submission documents. Responded to deficiencies from regulatory authorities to expedite approvals.

Regulatory Submissions FDA Regulation Quality Assurance Deficiency Response

Assistant Manager

Cipla Limited

Sep 2016 - Jan 2018 (1 year 4 months)

Participated in clinical and regulatory strategy meetings, compiled and reviewed quality agreements, and ensured compliance of technical documents for submissions. Managed change control processes and negotiated with management for submission goals.

Clinical Strategy Regulatory Compliance Change Control Negotiation