Jwelisha Sindha
Brampton,ON
Summary
Dedicated Regulatory Affairs professional with a strong background in preparing and submitting regulatory submissions in eCTD format to Health Canada, EMA and MHRA. Experienced in ensuring compliance with regulatory requirements, performing risk assessments, and managing post-market product administration. Proven ability to coordinate with internal and external stakeholders, review and prepare regulatory documents, and maintain up-to-date knowledge of applicable guidelines. Adept at handling multiple projects and delivering high-quality results in fast-paced environments.
Overview
5
5
years of professional experience
Work History
Regulatory Affairs Executive
Syri Research Private Limited (SyriMed)
Vadodara, India
06.2019 - 02.2023
- Prepare and submit regulatory submissions (eCTD format) to Health Canada, European Medicine Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) ensuring accuracy, completeness, and compliance with regulatory standards.
- Conduct gap analysis on dossiers for ANDS submissions, identify weaknesses, and coordinate with partners/manufacturers to obtain necessary documents.
- Reviewed Drug Master Files and conducted gap assessments; provided feedback to partners on regulatory compliance.
- Review and maintain regulatory documents and standards; perform regulatory risk assessments for development projects.
- Prepare and respond to inquiries from regulatory authorities and business partners, managing deficiency responses effectively.
- Prepare product labeling, monographs, and support product listing on provincial formularies.
- Evaluate and manage post-market product changes, assess regulatory impact, and liaise with internal and external stakeholders.
- Develop and maintain regulatory tracking tools, oversee QA systems, and generate Standard Operating Procedures.
- Collaborate with functional groups and external partners for new projects and regulatory compliance.
Regulatory Affairs Intern
Centurion Remedies Private Limited
Vadodara, India
07.2018 - 01.2019
- Training in preparation of regulatory dossier for product registration in ASEAN (Myanmar and Singapore), LATAM countries (Cost Rica and Dominican Republic) and African (Nigeria and Botswana) region.
Education
Master of Regulatory Affairs -
Institute of Pharmacy, Nirma University
05-2019
Bachelor of Pharmacy -
Gujarat Technological University
04-2017
Skills
- Regulatory Submissions: Expertise in CTD format, electronic submissions (eg, Docubridge), and regulatory compliance
- Technical Knowledge: Strong understanding of CMC requirements, Canadian Food and Drugs Act, GMPs, ICH Guidelines, Health Canada Policies, Global regulatory requirements
- Document Management: Proficient in preparing, reviewing, and maintaining regulatory documents and standards
- Communication: Excellent written and oral communication skills; strong interpersonal abilities for stakeholder engagement
- Project Management: Ability to prioritize and manage multiple projects, meeting deadlines in a fast-paced environment
- Attention to Detail: Commitment to quality, accuracy, and detail in all regulatory activities
References
References available upon request.
Timeline
Regulatory Affairs Executive
Syri Research Private Limited (SyriMed)
06.2019 - 02.2023
Regulatory Affairs Intern
Centurion Remedies Private Limited
07.2018 - 01.2019
Master of Regulatory Affairs -
Institute of Pharmacy, Nirma University
Bachelor of Pharmacy -
Gujarat Technological University
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