Open to work
SWAROOP M
Bangalore,India
Work preference
Work Type
Full timePart timeContract workGig workSummary
Accomplished professional with expertise in Content Management Systems (CMS) and Veeva Vault management, demonstrating strategic regulatory acumen and proficiency in regulatory submission and RIM for 5 plus years. Proven track record in quality assurance and compliance auditing, complemented by strong negotiation and problem-solving skills. Adapt at cross-functional collaboration, leadership, and mentoring, with a focus on driving organizational success through effective team management. Career goals include leveraging skills to enhance regulatory processes and contribute to industry advancements.
Overview
5
5
years of professional experience
2021
2021
years of post-secondary education
Work history
Regulatory Submission Specialist
Pixacore
Mumbai
2024.12 - 2026.03
- Performed tagging and linking of regulatory submissions with thorough fact-checking to ensure accuracy, consistency, and compliance with U.S. regulatory standards.
- Coordinated U.S. and international regulatory submissions, including INDs/NDAs and post-approval supplements, ensuring compliance with FDA/EMA standards and accelerating approval timelines by 20%.
- Collaborated on the integration of CRM, MAP, and CLM systems with the data platform, optimizing data synchronization and enhancing cross-functional workflows.
- Collaborated with cross-functional teams (RegOps, Medical, Quality, and Content teams) to streamline processes and improve submission efficiency.
- Involved in strategic planning, document preparation, agency interactions, and cross-functional collaboration with US Clients.
- Assisted team members in executing daily operational tasks and project deliverables, ensuring smooth and timely workflows.
- Supported training sessions for new employees by explaining tools, workflows, and company procedures, contributing to faster and more effective onboarding.
- Full-time
Submission Specialist
Omnicom Media Groups
2023.10 - 2024.12
- Managed CMC regulatory submissions for biologics, overseeing dossier compilation and approval processes across multiple regions.
- Executed RA projects involving workflow optimization and cross-boundary collaboration, reducing submission delays by 15%.
- USFDA Ad/promo Submissions and Handled global labeling updates and variations, ensuring alignment with regulatory guidelines.
- Skilled in effectively using referencing and anchor tagging for assets.
- Proficient in reviewing and proofreading documents and configuration specialist, Veeva Vault, Regulatory Submissions (RIMS).
- Processing post-market report submissions and coordinating responses to the competent authority and Proficient in utilizing Fuse.
- Develop and uphold project documentation, which encompasses issue trackers for Ad promotions, delivery trackers for Archival, and resource utilization in Veeva PromoMats.
GRA Submission Analyst
Eli Lilly and company
2020.12 - 2023.11
- Involved in Advertisement/Promotional Submissions, Veeva PromoMats, eTMF Functional Check Studies, RIM Correspondence Archival.
- Involved in creating binder through Veeva PromoMats, working on submissions in RIM, creating sequence in eCTD Xpress, and having hands-on experience with Veeva QualityDocs Production and Vault Clinical Production on a daily basis.
- Create and maintain project documentation, including issue trackers for Ad promo, delivery trackers for Archival, and resource utilization in Veeva PromoMats.
- Oversaw new product registrations and GMP inspections, collaborating with QA teams to maintain quality standards.
- Responsible for functional checks in eTMF work, with tailoring activities.
- Created data for the testing and implementation of Ad promo in RIM.
Education
M.Pharm -
B.Pharm - undefined
Class XII - undefined
Class X - undefined
Skills
- Content Management Systems (CMS)
- Cross-functional collaboration
- Leadership and Mentoring
- Negotiation and Problem-Solving
- Quality assurance and compliance auditing
- Regulatory submission and RIM
- Strategic Regulatory Acumen
- Veeva Vault management
PROJECTS
Post-Approval Variations and Lifecycle Management Project, Lilly, Managed post-marketing variations, supplements, and renewals for approved products, including labeling updates and risk management plans (e.g., REMS/RMP)., Medical Device Compliance and UDI Implementation Project, Manipal, Implementing Unique Device Identification (UDI) requirements for medical devices, including data entry, form reviews, and compliance reporting to meet FDA deadlines.
AWARDS & SCHOLARSHIPS
Top Performer Award Q4 Lilly, Lilly, Spot Excellence Award, Pixacore, Rising Star Award Q1, Lilly
Timeline
Regulatory Submission Specialist - Pixacore
2024.12 - 2026.03
Submission Specialist - Omnicom Media Groups
2023.10 - 2024.12
GRA Submission Analyst - Eli Lilly and company
2020.12 - 2023.11
M S Ramaiah University of Applied science - B.Pharm,
Vishwa Chetana vidyaniketana PU college - Class XII,
Widia Poorna Prajna School - Class X,
Manipal College of Pharmaceutical sciences - M.Pharm,