Elysia Gregorio

About Me

Hi, my name is Elysia. I've been a registered pharmacist since January 2022, currently based in Manila, Philippines.

Key Strengths

• Learning agility
• Self-management
• Flexibility

Contact

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<aside> <img src="https://th.bing.com/th/id/OIP.2KQM0vmLiSK13pYuMP9GmgAAAA?pid=ImgDet&rs=1" alt="https://th.bing.com/th/id/OIP.2KQM0vmLiSK13pYuMP9GmgAAAA?pid=ImgDet&rs=1" width="40px" /> LinkedIn

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Skills

Project Management

I'm able to work independently and balance multiple tasks. I'm passionate about efficiency while taking into consideration both process and people which makes me adept in solving issues at all levels of a project. I value the importance of tracking, recording and documenting.

Tech Proficiency

Now that we are living in a more technologically forward society, integration of healthcare and tech is necessity at this point. I’m self-motivated and value innovative solutions for accessibility and efficiency of process and systems.

<aside> 📑 Regulatory Tools

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• Veeva Vault
  • Quality
  • RIM - Business Development Lifecycle Management
  • RIM - Regulatory Archive Document Repository
• Regulatory Enterprise Document Source (REDS) by Open Text Life Science Solutions
• Global Artwork Management System (GLAMS) by Perigord Data Solutions
• Business Workflow Enablement for Labeling (BWEL) by Appian
• One Regulatory Information Online Network (ORION) by Liquent

<aside> <img src="/icons/paint-brush_gray.svg" alt="/icons/paint-brush_gray.svg" width="40px" /> Design

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• Adobe CC Suite
• Canva
• Procreate

<aside> <img src="https://img.icons8.com/ios/2x/engineering.png" alt="https://img.icons8.com/ios/2x/engineering.png" width="40px" /> Project Management and Other Technical

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• Notion, Trello/Kanban , MS Planner
• MS Office +
  • Sharepoint (Lists, Forms)
  • Power Automate
• GSuite
• TIBCO Nimbus
• Proofreaders
  • Global Vision
  • Text Verification Tool 12.0 (TVT) by Schlafender Hase

<aside> <img src="/icons/user_gray.svg" alt="/icons/user_gray.svg" width="40px" /> Soft Skills

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• Effective communication skills
• Visual storytelling
• Marketing
• Learning Agility

Experience

June 2023—

Present

Regulatory Affairs Specialist, International Labeling Support - AP Team

Merck Sharp and Dohme (I.A.) LLC

• Pioneer member of the Shared Services Delivery Model (SSDM) and subsequently, International Labeling Support (ILS) team, collaborating across regions to establish and enhance labeling and artwork processes.
• Developed and proofread high-accuracy scientific labeling and artwork for multiple Asia-Pacific markets.
• Manage end-to-end product labeling and artwork operational activities for AP countries (ex-Japan/China), ensuring compliance with country-specific procedures and global standards
  • Ensure a reduced submission preparation time (< 28 days for artwork, up to 42 days for labeling depending on review)
  • On-time release to country RA resulting to 100% on-time submission. Reducing the need for rushing or expediting packages by careful assessment, planning and close collaboration with stakeholders.
• Therapeutic area responsible for cardiovascular, metabolics, molnupiravir and HPV 9-valent vaccine before switching to a market-based approach.
• Current market responsible for Australia, New Zealand, Thailand, Cambodia, Laos, and Myanmar. Spearheads monthly meetings with said country RAs/Labeling & Artwork SMEs for cascading of cross-functional team information from top-down and receiving feedback to relay from the bottom-up.
  • Past lead rotations: Singapore, Brunei, Indonesia, Taiwan, Hong Kong, Malaysia, India sub-region, and Philippines
• Global lead for labeling and artwork tracking tool innovation team. Develops and improves solutions to tracking labeling and artwork activities, collaborating with local RA, and displaying metrics. Spearheads automation improvement on collaboration tool by metadata field mapping across systems
• AP representative to the Services Delivery Model Innovations Core Team for system and process improvements.
• Sub-lead for labeling and artwork quality and compliance. Monitors and provides solutions for monthly metrics monitoring and dashboard creation.
• AP Regional SME for Veeva Vault Rim (Business Development Lifecycle Management). Releasing monthly metrics; Providing BDLM walkthroughs; Coordination with other functions such as global contracts management, PV agreement lead and business partner liaison teams for partner constant updating and other concerns
• Team SME for tools concerning labeling and artwork such as the tracker, labeling repository, Veeva Vault Rim BDLM, QRD format check bot; Representative in the Regional Process and Digital Forum
• Created and maintains a standard operating procedure for the labeling and artwork process within the region
• Initiated Artwork Management System harmonization project; Collaborates with country RAs, supply chain and other functions for alignment and collating best practices; Writes AMS harmonized job aid
• Supported country projects such as site disentanglement projects for AP, legal entity name / copyright / business address changes for AP, and PV audit support for Malaysia and Philippines
• Immersion in cross-pollination initiative with CMC – Templatable Submissions for Compendial Updates and Legal Entity Changes.
• Shadowing activities with Regional Submissions Planning on eCTD post-approval submissions

Freelance Work

Internships

Education