プロフィール詳細

プロジェクトを作成

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Soutik D.に依頼

India

Regulatory Affairs Specialist | Drug Dossier Compilation | CDSCO, USFDA, EMA | eCTD/CTD | Remote & Part-Time available

プロフィール概要

About Me I am a Regulatory Affairs professional with hands-on internship experience in the pharmaceutical sector, specializing in drug dossier compilation, regulatory documentation, and submission support across Indian and international regulatory frameworks. During my internship, I gained practical exposure to CTD and eCTD document preparation, CDSCO Schedule Y compliance, regulatory writing, and literature-based gap analysis. I am familiar with ICH guidelines including Q8, Q9, Q10, Q1A(R2), E2C(R2), and M4, and actively expanding my working knowledge of USFDA 21 CFR Part 314 and EMA submission requirements. What I offer: I support pharmaceutical companies, biotech startups, and CROs with regulatory dossier compilation, CTD Module preparation, gap analysis reports, PSUR summaries, regulatory writing, and submission ready document formatting. I work remotely on a part time or project basis, which means you get focused, deadline-driven support without the overhead of a full time hire. Why work with me: I bring attention to detail, a strong science foundation, and genuine commitment to quality. I am honest about my experience level and will always deliver work that is accurate, well-structured, and aligned with the regulatory guidelines applicable to your target market. Available for: CDSCO, USFDA, and EMA dossier support, regulatory gap analysis, CTD/eCTD document compilation, PSUR writing, literature reviews for regulatory submissions, and regulatory compliance checklists. I am currently available for new projects and happy to discuss your requirements before you commit.

専門分野

• ☆ Drug Development
• ☆ Drug Formulation
• ☆ Preclinical ADME/PK/PD
• ☆ Preclinical Research
• ☆ Pharmacogenomics
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Pharmaceutical Management

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing

Research Market Research, Fact Checking, Gap Analysis, Systematic Literature Review

Consulting Business Strategy Consulting, Healthcare Consulting, Regulatory Consulting

Product Development Formulation, Quality Assurance & Control (QA/QC), Product Compliance

職務経験

FRD - Management Trainee

Mendine Pharmaceuticals Pvt Ltd

3月 2026 - 現在

PG Scholar

Indian Institute of Technology Dhanbad

7月 2024 - 現在

Regulatory Affairs Trainee

DDReg Pharma Pvt Ltd

7月 2025 - 3月 2026

Quality Control Officer

Macleods Pharmaceuticals Ltd

8月 2022 - 6月 2023

学歴

Advanced Diploma

Jamia Hamdard

7月 2025 - 6月 2026

Mtech

Indian Institute of Technology ISM Dhanbad

7月 2024 - 5月 2026

Bpharm

Dr B C Roy College of Pharmacy and AHS

8月 2018 - 6月 2022

認定資格

• Good Regulatory Practice

  WHO, BRIC, thsti, CDSCO

  4月 2025 - 現在

• Good Clinical Practice

  NIDA

  2月 2025 - 現在

• ICH GCP E6 R3

  Gcp training

  2月 2025 - 現在

• Scientific Writing

  ICMR

  10月 2023 - 現在