Naga Srilekha Somu
Buffalo Grove,IL
Summary
Regulatory professional with 7+ years of experience in the pharmaceutical industry. Expertise in submitting advertising and promotional submissions to the FDA, showcasing strong project management and analytical skills. Proficient in various publishing tools and experienced in managing 77 projects in a single day, ensuring compliance with FDA regulations.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Specialist
Celegence LLC
03.2019 - Current
- Prepare and submit 2253 promotional material submissions for all pharmaceutical prescription drug products to OPDP, utilizing company standards and guidelines, as well as Food and Drug Administration (FDA) regulations to ensure compliance
- Publish electronic Ad/Promo submissions to FDA using docuBridge
- Process and publish submissions for Subpart H and Subpart E to OPDP
- Prepare and publish Advisory comments, correspondences, and TV commercial submissions to OPDP
- Create compliance package binders and process 2253s in Veeva Vault PromoMats
- Work closely with onshore and offshore teams to streamline all communications internally and externally
- Prepare and present project status report for every Quarterly Business Review meeting and ensure minutes are documented and distributed to all the team members
- Lead and facilitate communication with the members of the marketing team ensuring that the project deliverables are completed in a timely manner
- Assist and support internal audits performed by the Client
- Organize and execute complex research projects and conduct experimental analysis by using various tools to enhance the work efficiency and submit the reports to the health authorities
- Work with leadership team to create assessment plans to identify and develop process improvements
- Prepare, execute internal and external audit reports, and analyze any major and minor deviations within the reports
- Prepare, analyze, and interpret KPI metrics for global submissions made within the US and draw comparative conclusion reports for Americas, Asia, and EMEA
- Design and create departmental newsletters and promote them by giving PowerPoint presentations for management review
- Work on different simple, medium, and complex level submissions of various products promotional material types like Websites, Videos, Exhibits, Formulary Kits, Direct Mail, Print Ads, Slides, Electronic Detail Ads etc
- Work with Marketing and Commercial Operations in distributing promotional materials to healthcare professionals and patients
- Involve in planning and submitting promotional materials to FDA, which effects the distribution of promotional materials in the market
- Ensure all the promotional materials submitted meet FDA 2253 submission guidelines
- Review various types of promotional materials for accuracy and compliance with regulatory requirements, as well as noting deficiencies and inconsistencies
- Worked with Electronic and Non-Electronic submissions of promotional materials to FDA
- Prepared and submit CD submissions of various promotional materials to FDA on cover 2253
Regulatory Material Approval Process (MAP) Specialist
Planet Pharma LLC
08.2017 - 03.2019
- Prepared FDA 2253 forms for all pharmaceutical prescription drug products, utilizing company standards and guidelines, as well as Food and Drug Administration (FDA) regulations to ensure compliance
- Prepared and submitted CD submissions of various Advertising and Promotional (Ad/Promo) materials to FDA on cover 2253
- Worked on various products promotional material types like Websites, Videos, Exhibits, Formulary Kits, Direct Mails, Banner Ads, TV Ads etc
- Played key role in submission planning of 2253 materials to OPDP during important product launches, which are business critical
- Handled complex submissions and managed heavy workload (Record of submitting 58 projects and 7 multiple submissions in a single day)
- Strictly followed submission deadlines by working with cross-functional teams to achieve completion of Rush projects
- Processed, reviewed, and submitted Non-electronic Promotional material submissions (Binders) for various pharmaceutical products to the FDA
- Generated monthly report for all the submissions made in Japan, US and Europe that includes creating compliance reports by analyzing the data given in the summary section of specific month
Submissions Specialist (Regulatory Affairs) - Independent Contractor
Rao Solutions, Inc.
03.2017 - 05.2017
- Processed Pre-IND and IND documents prior to the USFDA submission: Creating hyperlinks, bookmarks, references, cross-references, and preparation of PDFs according to the company standards
- Archived paper and electronic submissions and related documents per internal SOPS
- Assist in Quality Review of eCTD submissions, paper submissions and reports to ensure compliance
- Managed heavy workload and ensured timelines were met by having simplified processes, which enabled a quick turnaround
- Imported formatted documents into document management system and routed for approval
- Generated submission Table of Contents and troubleshoot document formatting issues
- Used various Microsoft word templates to prepare IND submission documents for amendments and correspondences
- Performed high Quality checks on all submission documents as per the guidelines
Teaching Assistant
Western Illinois University
Macomb, IL
08.2015 - 12.2016
- Handled course attendance and grade tracking as per Department of Chemistry standards
- Lectured Organic Chemistry practical labs and proctored various practical examinations.
- Prepared various chemical solutions required for conducting organic chemistry practical labs.
- Evaluated lab reports under supervisory guidance
- Assisted students with inquiries throughout laboratory sessions
- Formatted research documents efficiently
- Exported data using advanced data management tools according to supervisor's instructions.
- Carried out administrative duties by recording the class attendance, preparing and setting up chemicals, glassware and scientific instruments required for the labs assigned.
- Assisted Professors in maintaining Lab environment by adhering to safety rules of the University.
Education
Master of Science - Chemistry
WESTERN ILLINOIS UNIVERSITY
Macomb, IL12.2016
Master of Pharmacy -
KAKATIYA UNIVERSITY
Warangal, India12.2013
Bachelor of Pharmacy -
KAKATIYA UNIVERSITY
Warangal, India04.2011
Ph.D. - Business Administration and Management
UNIVERSITY OF THE CUMBERLANDS
Williamsburg, KYSkills
- Regulatory Affairs professional over 7 years of experience
- Quick learner, multi-tasker and a great team worker with good analytical skills, problem solving ability and excellent time management and project management skills
- Enthusiastic in learning business health care processes required for managing health care professionals and administration
- Good command on Publishing tools like eCTD Xpress and docuBridge
- Extensive knowledge on ICH and FDA regulations
- Worked with Veeva Vault (Global PromoMats and RIM), eCTDXPress, docuBridge, Adobe Acrobat, ISI ToolBox, MS-Office 2019, SharePoint, Documentum
Certification
- Member of Drug Information Association (DIA)
- Registered Pharmacist in Indian Pharmacy Council (IPC)
Languages
English
Professional
Hindi
Limited
Telugu
Professional
Graduate Thesis
- Multi-component reactions to synthesize 4-phenyl pyridine derivatives.
- Formulation, Development and Evaluation of micro-emulsion based gel for the treatment of Psoriasis.
Timeline
Regulatory Affairs Specialist
Celegence LLC
03.2019 - Current
Regulatory Material Approval Process (MAP) Specialist
Planet Pharma LLC
08.2017 - 03.2019
Submissions Specialist (Regulatory Affairs) - Independent Contractor
Rao Solutions, Inc.
03.2017 - 05.2017
Teaching Assistant
Western Illinois University
08.2015 - 12.2016
Master of Science - Chemistry
WESTERN ILLINOIS UNIVERSITY
Master of Pharmacy -
KAKATIYA UNIVERSITY
Bachelor of Pharmacy -
KAKATIYA UNIVERSITY
Ph.D. - Business Administration and Management
UNIVERSITY OF THE CUMBERLANDS
Similar Profiles
Mithun NMMithun NM
Subject Matter Expert at CelegenceSubject Matter Expert at Celegence
Sree Varsha DatlaSree Varsha Datla
Medical Writer I at CelegenceMedical Writer I at Celegence
Sovan MahapatroSovan Mahapatro
MANAGER at Celegence Systems Pvt LtdMANAGER at Celegence Systems Pvt Ltd