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Managerial/ Executive level openings in Human Resource/ Operations with an organization of repute.

A motivated Chartered Accountant with three years of articleship experience and one year as an executive at KPMG, followed by two years of post-qualification experience as an executive at EY, specializing in the statutory audit domain. Seeking a challenging and dynamic environment that offers substantial career growth opportunities. Dedicated to continuously enhancing my skills, striving for excellence, and contributing to the success of the organization to the best of my abilities.

Total Experience :- 5 Year

  Expertise in crafting and Review ACTD & CTD dossiers for multiple countries, ensuring compliance with specific regulatory guidelines.
  Proficient in reviewing and evaluating complex technical documents for data integrity, demonstrating attention to detail in assessing Stability Data, Process Validation Reports, Dissolution study, DMF and various impurity-related documents such as Genotoxicity Impurities, Nitrosamine Impurities, Elemental Impurities, and other critical components.
  Extensive experience in post-approval activities, including variations and product lifecycle management.
  Skilled in coordinating and submitting New GMP applications for plant accreditation by global regulatory authorities.

Global Dossier Preparation and Submission:

  Extensive experience in preparing and submitting ACTD & CTD dossiers for regulatory approvals across diverse regions, including:
  Regulatory Market : Health Canada (work on one project complies & Reviewed the CMC section).
  Asia Region: Philippines FDA, Vietnam, Myanmar, Cambodia, and more.
Africa Region: Rwanda, Kenya, Nigeria, Ethiopia, Botswana, Zimbabwe, Tanzania, and numerous others.
Middle East Region: Syria, Libya, Lebanon, Iraq, Yemen, and additional countries.

Cross-Functional Collaboration:

  Proven ability to collaborate seamlessly with different departments, including Research and Development (R&D), Quality Assurance (QA), Quality Control (QC), and clinical trials teams.
  Actively engage in regular follow-ups with R&D personnel to stay updated on the latest developments and ensure alignment between regulatory requirements and product development.
  Work closely with QA and QC teams to maintain stringent quality standards in documentation and processes, contributing to the overall compliance and success of regulatory submissions.
  Collaborate with clinical trials experts to integrate trial data seamlessly into regulatory dossiers, ensuring a cohesive approach to submissions.
  Facilitate effective communication channels between regulatory affairs and other departments, promoting a holistic understanding of project requirements and timelines.

Regulatory Intelligence and Product Research:

  Expertise in conducting comprehensive research on Innovator products and generic players globally (UK MHRA, TGA, Heath Canada, USFDA, EU and rest ROW market such as Philippines FDA, Malaysia and many more) through the examination of Product Assessment Report (PAR), Summary of Product Characteristics (SMPC), and Patient Information Leaflets (PIL).
  Systematically extract key details, including pack size, product description, shelf life, and formulation specifics, contributing valuable insights for product development.
  Thoroughly analyze and interpret bioequivalence study data, leveraging acquired information for strategic decision-making in the development of regulatory dossiers.
  Stay abreast of industry trends, regulatory updates, and competitor products, providing valuable regulatory intelligence to inform the regulatory strategy and maintain a competitive edge.
  Collaborate with cross-functional teams to integrate acquired intelligence into regulatory submissions, ensuring alignment with regulatory requirements and industry best practices.

Targeted Regulatory Expertise:

  EU (European Union):Demonstrated proficiency in preparing and filing dossiers in compliance with the rigorous regulatory standards of the European Medicines Agency (EMA).
  USFDA (United States Food and Drug Administration):Extensive experience in crafting submissions aligned with the stringent requirements of the U.S. Food and Drug Administration, ensuring adherence to cGMP guidelines.
  Health Canada: In-depth knowledge of the regulatory landscape in Canada, adept at preparing dossiers to meet the rigorous standards set by Health Canada.
  NPRA Malaysia (National Pharmaceutical Regulatory Agency):Proven track record in navigating and satisfying the regulatory requirements of NPRA Malaysia, ensuring successful product registrations in the Malaysian market.
  Stringent Regulatory Bodies: Well-versed in working with various stringent regulatory bodies worldwide, including [mention any other specific bodies], showcasing adaptability to diverse regulatory environments.




To think innovatively, face challenging situations which can would me to PERFECTION.

Seeking a challenging and growth oriented career where I can fully utilize my skill and available resources with the opportunity for professional growth and to excel by contributing towards the achievement of organizational goal.

Vijay Vijay

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