Samriti Marcharchand
Port Louis
Summary
Results-driven professional with 8 years of focused experience in regulatory affairs and artwork management for pharmaceutical products. Demonstrated success in cultivating cross functional relationships with individuals to optimize goals and output, resolve complex problems and deliver innovative process improvement strategies to ensure compliance and efficiency. Valued for strategic thinking, clear communication and reliability as a team leader.
Overview
8
8
years of professional experience
Work History
Associate Manager - Artwork Management
Aspen Global
03.2024 - Current
- Lead a 7-member artwork team that ensured preparation and maintenance of drug product labeling to support new registrations and other post-licensing activities, and are in compliance with applicable regulations and standards for pharmaceuticals.
- Provide coaching and guidance to the team to develop timelines for activities associated with regulatory filings and preparation of labelling changes in collaboration with the manufacturing sites and affiliates.
- Spearheaded process improvement initiatives, increasing team efficiency and improving team metrics by 25%.
- Act as the key point of contact and escalation to resolve issues highlighted by team.
- Review and critically assess deviations related to artwork and put in place robust corrective/preventive actions with Supply Chain and Quality to avoid supply impact and product recalls.
- Manage budget forecasting for the artwork team, improving the financials by 10% by reducing the artwork costs.
Senior Regulatory Affairs Associate
Aspen Global
01.2022 - 02.2024
- Autonomously managed all regulatory activities for over 20 generic products (mainly anesthetic and oncological products), 10 technical projects and documents for submission to health authorities, with a 95% acceptance rate, ensuring no supply impact.
- Coordinated responses to regulatory inquiries from several health agencies, applying critical thinking and problem solving approach for timely approvals.
- Served as the primary regulatory representative in multidisciplinary project teams, ensuring all regulatory requirements were understood and met for each new product launch. On time regulatory approval and launches for 10 products in multiple regions.
- Defined regulatory strategies and timelines for proper implementation at manufacturing site for related products in around 90 global markets
- Acted as the interface between supply chain and global regulatory affiliates for supply related matters and supported in the risk assessment and mitigations.
- Coached other Regulatory team members with respect to technical knowledge and management of daily activities and seek for their professional development, improving their efficiency by 15%.
- Implemented an internal audit of regulatory procedures, identifying areas for improvement that increased overall departmental compliance by 10%
Regulatory Affairs Associate
Aspen Global
01.2020 - 12.2021
- Assisted with the preparation and submission of annual establishment registration and device listings for the company
- Performed and documented quality control checks, and maintained at least 90% compliance with business initiatives.
- Autonomously managed non-technical projects and technical project assigned. Supported supervisor to drive projects which are critical to supply.
- Recommended improvements to processes
- Kept up-to-date with changes in regulatory legislation and guidelines and obtained marketing permissions.
Junior Regulatory Affairs Associate
Aspen Global
07.2017 - 12.2021
- Supported the regulatory team to manage all regulatory activities for 25 pharmaceutical products supplied across global markets
- Reviewed, updated and ensured data accuracy on regulatory database across the product lifecycle
- Collaborated with Quality Assurance to ensure proper maintenance of technical files for 25 existing products
Regulatory Compliance Administrator
Aspen Global
12.2016 - 06.2017
- General Administrative support for Regulatory Affairs Team including invoices and purchase orders processing.
- Review of trackers on an ongoing basis to ensure relevant status and information is updated. Support on following up on regulatory monthly deliverables.
Education
MBA -
Rome Business School
Rome, Italy07-2024
Bachelor of Science - Medical Bioscience (Honours)
Monash University
Malaysia08-2016
Skills
- Regulations: EU, APAC, Health Canada, ANVISA, COFEPRIS, NMPA Regulations, GMP, ICH Guidelines
- Techniques: Risk Management, Project Management, Quality Assurance, Regulatory submissions, Vendor Management, Regulatory Strategy Development, SOP development
- Software: Microsoft Office, SharePoint, Adobe Acrobat, Trackwise, QAlign, VEEVA, RIMS, Esko Artwork system
Timeline
Associate Manager - Artwork Management
Aspen Global
03.2024 - Current
Senior Regulatory Affairs Associate
Aspen Global
01.2022 - 02.2024
Regulatory Affairs Associate
Aspen Global
01.2020 - 12.2021
Junior Regulatory Affairs Associate
Aspen Global
07.2017 - 12.2021
Regulatory Compliance Administrator
Aspen Global
12.2016 - 06.2017
MBA -
Rome Business School
Bachelor of Science - Medical Bioscience (Honours)
Monash University
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