Open to opportunities

Nila Sankpal

@nilasankpal

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Seasoned Global Regulatory Leader with expertise in FDA and EMA processes.

Germany

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What I'm looking for

I seek opportunities that challenge me and allow for impactful contributions to global health.

I am a seasoned Global Regulatory Leader with over 10 years of experience in regulatory affairs, specializing in navigating FDA, EMA, and Health Canada approval processes. My proven track record includes successful submissions and FDA approvals across various markets, including the US, EU, and Canada. I excel in leading cross-functional teams and managing complex regulatory projects, driving organizational change for optimal regulatory compliance and product success.

Currently, I serve as a CMC New Products Sterile Specialist at Pharmathen SA, where I assist in the development and review of regulatory documents, ensuring high-quality submissions for EMA, USFDA, and Health Canada. I have successfully led the regulatory submission and approval process for multiple products, achieving FDA clearance within GDUFA goal dates. My experience also includes directing regulatory submissions at APOTEX and managing resources at Harman Finochem, where I ensured compliance and successful registrations.

Experience

Work history, roles, and key accomplishments

Current

CMC New Products Sterile Specialist

Current

Pharmathen SA

Jan 2022 - Present (3 years 6 months)

Assisted with the development and review of regulatory documents for EMA, USFDA, and Health Canada (HC) submissions, ensuring successful registration and pre-approval. Coordinated and organized regulatory information, data, and documents as a project manager.

Regulatory Submissions Project Management

Team Leader - Regulatory Affairs

Apotex Research Private Limited

Mar 2021 - Present (4 years 4 months)

Directed the preparation of cGMP-compliant regulatory submissions for ANDA, IND, and CTA filings for US and Canadian markets. Coordinated with cross-functional departments, including global regulatory affairs teams, ensuring successful registration and pre-approval.

Regulatory Submissions Product Lifecycle Management

Head (Assistant Manager) - Regulatory Affairs

Harman Finochem

Oct 2020 - Present (4 years 9 months)

Planned and managed resources for the Regulatory department as a project manager. Led the review and submission of cGMP-compliant application dossiers for OSD forms, including IND/CTA/MAA, to regulatory authorities such as USFDA and EMA.

Project Management Regulatory Submissions

Senior Regulatory Affairs Specialist

PAR Formulations Pvt Ltd

Oct 2018 - Present (6 years 9 months)

Administered ANDAs for OSD forms and injectables by gathering and reviewing all CMC modules. Managed the product lifecycle for the Europe market, including renewals, variations, and change controls.

ANDA Product Lifecycle Management Regulatory Compliance

Senior Executive - Regulatory Affairs

Strides Pharma Science Limited

Jun 2017 - Present (8 years 1 month)

Compiled, reviewed, and submitted ANDAs as well as post-approval submissions for Solid orals, Liquid orals, and Semisolid dosage forms for the US market. Analyzed drug master files (DMFs) and CMC documentation.

ANDA

Assistant Manager - Regulatory Affairs

Cipla Limited

Nov 2015 - Present (9 years 8 months)

Consolidated variation packages, renewals, and re-registration dossiers for the EU market. Managed post-approval submissions for the US, such as PAS, CBE-30, CBE-0, and AR.

Post Approval Submissions Regulatory Compliance

Executive - Regulatory Affairs

Lupin Limited

Apr 2013 - Present (12 years 3 months)

Compiled post-approval activities, including annual reports for the US market. Enforced regulatory compliance for OSD forms in the US and EU by reviewing CMC documentation.

Regulatory Compliance Post Approval Activities

Education

Degrees, certifications, and relevant coursework

Nagpur University (RTMNU)

Master of Pharmacy, Quality Assurance

Completed a Master of Pharmacy with a specialization in Quality Assurance. Gained in-depth knowledge of quality control and regulatory compliance within the pharmaceutical industry.

Nagpur University (RTMNU)

Bachelor of Pharmacy, Pharmacy

Obtained a Bachelor of Pharmacy degree, building a foundational understanding of pharmaceutical sciences. Developed core competencies in drug formulation, pharmacology, and pharmaceutical chemistry.