Dr. Sameer Shaikh (Ph.D, Pmp®) Email & Phone Number

Mumbai, Maharashtra, India

Navi Mumbai, Maharashtra, India

-Prepared regulatory submissions (EU/UK Dossier, Variation Package & deficiency response) compilation, review & publication in the e-CTD framework.- Orchestrated the regulatory strategies for new product development and provided strategic, scientific, and regulatory inputs for CMC and procedural aspects.- Performed review of development and submission batches docs.- Identified gaps and formulated process improvement plans by working collaboratively with the leadership team, resulting in improved organizational productivity and efficient business operations.- Involve in the product launch activity in EU/UK, guiding the cross-functionally for the same.- Involve in the finalisation of BR/BT site, and PV service provide.- Involve in the QP audit at the API/intermediate manufacturing site.

Thane, Maharashtra, India

• Prepared regulatory submissions (ANDA, amendments & supplements) compilation, review and publication in e‐CTD framework. • Orchestrated the regulatory strategies for new product development and provided strategic, scientific and regulatory inputs for CMC and procedural aspects. • Performed review of development and submission batches docs, in addition to review and finalization of technology transfer docs.• Planned, coordinated, and directed Regulatory Affairs programs, to ensure continuous process improvement in compliance with current Regulatory guidelines.• Identified gaps and formulated process improvement plans by working collaboratively with the leadership team, resulting in improved organizational productivity and efficient business operations.• Collaborated cross-functionally and maintained seamless communication between internal / external stakeholders, ensuring business deliverables are met.• Headed the RA program including on-going development and implementation, and maintenance. • Directed Regulatory Affairs team leading to high quality project deliverables and minimized non- conformance issues.• Regulated and supervised the audit functions to monitor the compliance of processes as per current Regulatory requirements.• Participated in the monthly Operational Meetings to review KPI, while overseeing the budget and capital plans for the projects. • Led the RA/PM team and consistently met key business deliverables through ongoing coaching, feedback and mentorship sessions.

Thane, India

• Acted as a Functional CMC Representative for Europe, Asia, Africa, Latin America and Middle East (GCC), while ensuring compliance as per the regulatory norms/requirements.• Crafted a CMC plan for the timely identification of New Drug Product for the European market. • Maintained regulatory submission files in accordance with the ICH and regulatory requirements.• Executed European CTD compilation of the products for DCP filling (Technical Review, Regulatory compilation & submission). • Enabled compilation and review of dossiers for European market for DCP procedure, MRP procedure and National Submission.

Mumbai, Maharashtra, India

• Handled EDQM (October 2018) & USFDA (January 2019) audits with zero observations.• Facilitated with Functional Experts to provide timely answers to CMC queries from regulatory agencies. • Served as a Functional CMC Representative on assigned New Drug Substance/New Drug Product Teams. • Devised risk mitigation plan & effectively communicated the project status to the clients as well as project heads. • Designed, executed and delivered projects within time and budget constraints, while ensuring alignment with the project scope. • Conducted regulatory review of production modifications within the change control structure and submitted plan advice to the Department of Technical Operations and Performance (Drug Substances/Drug Product).

Mumbai Area, India

• Navigated multi-function teams and implemented strategic business plans, ensuring alignment to corporate goals.• In-charge of compilation and review of dossiers for US (ANDA) & Europe market (DCP, MRP & National submission).• Initiated end-to-end regulatory compliance, including regulatory strategies‐submissions, timelines, and decisions on RLDs.• Ensured timely submission of technical data to queries received from Regulatory Authorities for under‐ registration products.• Supervised the compilation and review of variation package for Europe market as per variation guidelines (DCP, MRP & National). • Undertook planning, execution and maintenance of emerging markets Registration Dossiers, Re‐Registration Dossiers and Company Registration Dossiers. • Conceptualized regulatory strategies for new product development as well as provided strategic, scientific, and regulatory inputs for CMC and procedural aspects. • Performed the review of development and submission batches documents including analytical method validation protocols and reports, product development reports, specifications, and batch manufacturing records. • Coordinated and worked cross-functionally with International Marketing, R&D, Quality Assurance, Production, Contract Manufacturing Sites and Supply Chain for timely project delivery. • Engaged in compilation & review of DMF for US, EU, EDQM, Canada, Australia and international markets (Asia, Africa, Latam etc.) while ensuring strict compliance to the governing rules/regulations.

Navi Mumbai, Maharashtra

Navi Mumbai, Maharashtra

Thane, Maharashtra

Ph.D, Chemistry, 1St

Completed Ph. D in Chemistry for JJT university

M.Sc., Chemistry, 1St

Diploma In Pharmacy, Pharmacy

B.Sc., Chemistry

Hsc, Science

Ssc