- A focused and result-oriented professional with over 8 years of experience in Regulatory Affairs with Process Documentation. Having sound working knowledge of Chemistry Manufacturing and Controls (CMC), cGMP, FDA, EMEA and ICH guidelines. Skilled in prepare, coordinate and manage regulatory submissions (ANDA, NDA, MAA, CEP and DMF/API) for USFDA, EUROPE, GCC, SFDA, WHO, MENA, Emerging Market in CTD format (eCTD and NeeS submission). Proven skills in Life cycle management (Post Approval Changes, Renewal, Annual update, Variation, notification to support changes to authorize). Coordinate and prepare responses to requests for information from regulatory authorities.
- Currently associated with Saudi Pharmaceutical Industries, Saudi Arab as Senior Regulatory Affairs Executive. Capable of working in coordinating with the various departments like R&D, QC, QA, production & other department. Skilled at reviewing, ensure the documents are checked for quality & accuracy and that they are compliant with applicable Regulatory guidance. An effective communicator with excellent interpersonal, analytical & problem solving skills. Provide/encourage training and people development to increase productivity and performance.
Regulatory Affairs Assistant Riyadh, Riyadh Province, Saudi Arabia
Since January 2016
- Actively contribute to the development and implementation of regulatory strategy for assigned projects.
- Prepare, coordinate, and manage regulatory submissions (ANDA, NDA, MAA, CEP, and DMF/API) for USFDA, EUROPE, GCC, SFDA, WHO, MENA, Emerging Market in CTD format (eCTD and NeeS submission).
- Preparation of CMC information for submission to global regulatory agencies.
- Create SmPC, PILs and labeling in accordance with legal and regulatory requirements.
- Coordinate and prepare responses to requests for information from regulatory authorities.
- Ensure the documents are checked for quality & accuracy and that they are compliant with applicable Regulatory guidance/Legislation.
- Proven skills in Life cycle management (Post Approval Changes, Renewal, Variation, Annual update, notification to support changes to authorize).
- Develop and implement strategies for the timely preparation and execution of quality submissions to regulatory authorities of the product life cycle.
- Provide input into regulatory activities in order to obtain Marketing Authorisations for commercial products as rapidly as possible.
- Coordinate with external API and Precursor supply partners to manage regulatory submissions
- Review and communicate current & emerging regulatory requirements.
- Establishes strong and effective relationships with global regulatory teams thereby ensuring RA activities are in line with global and regional business priorities.
- Excellent organization skills and ability to work on a number of projects with tight timelines is required
- Keep updated of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset.
- Prepare Gap Analyses of pharmaceutical quality dossiers in the context of marketing authorization projects.
- Review and finalization of Analytical method validation reports and Carryover study reports.
- Effectively coordinated with the various departments like R&D, Analytical Development, QC, QA, Production and Corporate affairs.
- Assesses and communicates regulatory requirements for submissions and programs to ensure that all development activities are in compliance with applicable regulations and guidelines.
- Evaluating the change controls and preparing submissions (Supplements) arising from the change control process.
- Performing transitions from CTD to eCTD.
- Submission of documents through Electronic Submissions Gateway (ESG, CESP).
Skills and Expertise
Responsibility for the coordination of CMC-activities
Master in Pharmaceutical Sciences from nagpur univercity in 2010
Training and Certification
regulatory affairs in 2008 Certification