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Click here or scroll down to respond to this candidateCandidate's Name
EMAIL AVAILABLE, M: PHONE NUMBER AVAILABLE, LinkedIn: LINKEDIN LINK AVAILABLE PROFESSIONAL SUMMARY: Highly experienced professional with a proven track record in developing, managing, and ensuring compliance of regulatory documents within the pharmaceutical and medical device industries. Expertise in preparing, submitting, and reviewing regulatory documents (including 510(k) applications and Premarket Notifications) for compliance with FDA, EU, and international regulations. Adept at performing, leading, and facilitating editorial reviews for accuracy, consistency, and regulatory compliance. Strong ability to collaborate with cross-functional teams and pharmaceutical companies to deliver high-quality documentation. Committed to maintaining the highest standards of regulatory compliance and documentation accuracy. Eager to leverage expertise in Regulatory Affairs, Clinical Research, Project Management, and Scientific Communications. Holds Masters degree in Pharmacy.EDUCATION DETAILSMaster of Science, Regulatory Affairs & Services (Medical Devices) (Aug 2023 Jan 2025) St. Cloud State University, Minnesota, USA (Fall 2023) Master of Pharmacy, Pharmaceutical Analysis & Quality Assurance (Nov 2012 Dec 2014) Osmania University, Telangana, IndiaBachelor of Pharmacy (Jun 2008 Jun 2012)Kakatiya University, Telangana, IndiaWORK EXPERIENCEGraduate Assistant at St. Cloud State UniversityMinneapolis, MN, USA (Jan 2024 May 2024) Conducted research to inform strategic initiatives for promoting the Medical Technology (MedTech) graduate programs (Medical Technology Quality, Regulatory Affairs and Services, or Applied Clinical Research). Promoted and presented the MedTech graduate programs at major industry events and expos. Adeptly communicated the program's value proposition to industry stakeholders and cultivated interest among potential collaborators. Organized and volunteered at MedTech events and conferences, fostering connections with industry professionals and promoting program offerings to potential students. Scientific Communications Specialist at ZS Associates Pune, India (Oct 2021 Aug 2023) Performed editorial review of pharmaceutical documents (e.g., protocols, investigator brochures, clinical study reports, labeling, medical affairs reports, RFPs, product catalogs, advertising, promotional materials etc.) for accuracy, consistency, and compliance with brand & regulatory requirements. Assisted in the preparation and submission of 510(k) applications, Premarket Notifications, trial analysis, annual reports, change notifications, and other country-specific product registrations in compliance with US, EU, and other international medical device regulations and submissions for clients including Pfizer, Abbott, and 3M). Managed review meetings: captured key discussions, ensured accurate minutes, and facilitated distribution to stakeholders. Initiated and supported change control processes for global product registration, submission and post marketing of Administration and Safety System medical devices in clients portfolio. Prepared Technical Files/Design Dossier, Change Notifications, Submissions (e.g., Documentary Audits under MDD/MDR). Ensured compliance with US Food and Drug Administration (FDA) and international regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Conducted quality reviews of documents to ensure adherence to Good Clinical Practice (GCP) and other relevant guidelines. Reviewed and annotated Gilead and Moderna Report for proposals, as well as User/Non-user qualitative research studies. Collaborated with Regulatory and Medical writing teams. Executed targeted communications to our internal business unit stakeholders to increase awareness of compliance responsibilities.Senior Quality Reviewer at Ernst & YoungKochi, India (Oct 2019 Sep 2021) Reviewed medical, clinical, consulting related documents for quality and consistency in visual elements, content, brand, and regulatory compliance. Collaborated with multiple stakeholders like Takeda, Daiichi Sankyo, Biogen, Sun Pharma, Novartis etc., and local leads, also managed a team for consulting queries regarding EY Brand. Collaborated with a cross- functional team to assist them prepare and submit various documents. Supported as a business analyst for Analytic committee to promote Program impact reporting tool and learned new things about dashboard, Agile methodology, Scrum, Gateway process etc., apart from the day-to-day work. Trained and oversaw new employees.Analyst - Quality Reviewer at Deloitte Support Services India Private Limited Hyderabad, India (Aug 2017 Jul 2019) Managed document version control and ensured proper documentation and archiving procedures to meet client brand requirements. Supported UK design team in reviewing documents for quality and consistency in design and content. Proofread and copy-edited several types of MS word, PPT, PDF, InDesign, Visio files, Brochures etc., and ensuring error-free copies. Collaborated with multiple stakeholders like J&J, Gilead, Amgen, Moderna, Alnylam, Pfizer, Eli Lilly, and AbbVie. Collaborated with a cross-functional team to assist them prepare and submit various documents. Assistant Managing Editor at OMICS InternationalHyderabad, India (Oct 2014 Aug 2017) Managed open access clinical & pharma journals, articles, and conferences. Reviewed, edited, and proofread articles/manuscripts and made them appropriate with the journal standards. Thoroughly checked journal home pages and editorial manager and interfaced with clients on a regular basis to meet their expectations while overseeing articles. Maintained internal quality systems, training and specifications, processes, and policies to ensure compliance to quality, confidentiality, and security. Wrote blogs, created content, and implemented strategies to increase the number of abstracts, manuscripts, journal memberships, and collaborations. Trained and monitored team members.TECHNICAL SKILLS Regulatory knowledge (ICH guidelines, FDA regulations, ISO 13485, eSTAR, IDE Regulations and Clinical Trial Design etc.), quality assurance principles and procedures, and scientific writing. Document quality review, visual identity review, proofreading, copy-editing, Brand management, e-publishing, article writing, data analyzing, and email marketing. Ziflow, Veeva vault PromoMats, MS office tools, Math type version 6.9, Editorial Manager version 12.2, Perl Software, Large text file viewer 5.2u and Six Sigma White Belt. Scientific data retrieval from databases like ScienceDirect, PubMed, Cochrane and Micromedex. Domain knowledge (therapeutic areas, regulatory guidelines, drug development process, and basic statistical/clinical concepts).CERTIFICATIONS Medical Device Regulation 2017/745 EU Regulatory Affairs (Dec 2022, Issued by Udemy) Drug Regulatory Affairs (DRA) (Nov 2022, Issued by Udemy) Pharmacovigilance (Feb 2023, Issued by Udemy) Project Management: Healthcare Projects (Oct 2023, Issued by Project Management Institute) Lean Six Sigma Foundations (Oct 2023, Issued by Project Management Institute) Medical Writing for Healthcare Professionals (Jan 2023, Issued by Udemy) RAPS Member (Apr 2024, Issued by Regulatory Affairs Professionals Society) Interpersonal Emotional Quotient Badge (Jan 2024, Issued by St. Cloud State University) Data Visualization Bronze Badge (Feb 2021, Issued by EY) Design Thinking Bronze Badge (Aug 2020, Issued by EY) ACHIEVEMENTS/ACTIVITIES Organized Spring Fest, MedTech graduate speaker series, Resume workshop, Interview process workshop, LinkedIn seminar, MedTech graduate information sessions for local and international students, and MedTech graduate student Career Fair. Elected and working as a President of ENCQR (Emerging Network of Clinical, Quality, and Regulatory Professionals) Committee and as a Graduate Assistant for MedTech Programs at SCSU Plymouth. Attended 2023 Minnesota Quality Conference and Power in Diversity Leadership Conference as an ambassador and gained Leadership, Interpersonal EQ Badges. Attended conference on Real-World Biocompatibility for Regulatory Affairs Professionals organized by RAPS Twin Cities Chapter. Volunteered for a RAPS 101 conference on Design of Medical Devices at University of Minnesota. Earned two bronze badges in Analytics-Data Visualization and Design thinking. Volunteering as a Regulatory Affairs Professionals Society (RAPS) member and ASQ Student Member. Received spot awards for exceptional performance and exceeding expectations from EY, Deloitte, and OMICS International during my tenure. Authored and published three review articles in open access clinical journals. PERSONAL SKILLS Thrives in cross-functional teams, achieving common goals through clear communication and fostering a positive, collaborative environment. Excels at prioritizing tasks, meeting deadlines, and effectively managing multiple projects to ensure timely regulatory submissions. Possesses a strong ability to navigate complex regulations and develop compliant solutions, ensuring adherence to industry standards. Embraces new challenges with a growth mindset and readily adjusts to evolving regulations and best practices. |
