Clinical Research Data Management

Dheeptha Selvadoss

Lewis Center,Ohio

740-***-****

ad5drk@r.postjobfree.com

SUMMARY

With 6 years of experience in Regulatory Affairs looking to pursue a challenging career in regulatory field and become a part of esteemed organization where I can use my skills, knowledge, and experience to contribute to the life science industry. Detail oriented, highly organized, proactive and action -oriented with strong technological aptitude.Works both independently and in a mulDdisciplinary team with the ability to communicate in cross-cultural organization. CORE COMPETENCIES

• Strong experience in publishing and submission of documents.

• Assisted with the development and/or review of regulatory documents resulDng in submission to regulatory agencies worldwide.

• Experience in eCTD dossier submission with eCTD soJware.

• Strong experience in Chemistry Manufacturing and Control (CMC) documentaDon related to Drug Substance(DS) and Drug Product(DP).

• Well versed with Pharmacovigilance acDviDes.

• Prepared annual reports (PSURs,DSURs ) and submiPed to regulatory bodies.

• Knowledge and experience with Clinical Data Management.

• Additional experience in generating ANDA documents with FDA guidelines with more focus on CMC.

• Familiarity with the drug and medical device development process.

• Strong knowledge and understanding of ICH guidelines, cGMP, GLP, GCP, IND, NDA,510K, Informed consent, IRB review and Ethical principles in clinical research.

• Exceptional knowledge in pharmaceutical biotechnology.

• Good oral and written communication skills.

• AddiDonal qualification-MS Office, MS Word, Outlook, PowerPoint, Typing, Windows, Adobe Acrobat, Q-pulse.

PROFESSIONAL EXPERIENCE

1. Navidea Biopharmaceu7cals Inc., Dublin, OHIO (2022 – 2024(April)) REGULATORY AFFAIRS MANAGER

• Responsible for providing regulatory support in Chemistry, Manufacturing and Control (CMC) for the company’s diagnosDc and therapeuDc products.

• CreaDng ICH complying eCTD documentaDon such as INDs, Module 3, Module 1 working along with contract manufactures.

• Responsible also for preparing applicaDons, forms, cover lePers, reports, data to regulatory agency.

• Publishing and submibng regulatory dossiers as well as product registraDon acDviDes.

• Assist in the establishment and maintenance of regulatory documentaDon, Quality Management System (QMS) procedures, work instrucDons and records.

• Assist the clinical team with documentaDon and submission.

• Act as Pharmacovigilance Regulatory Person with internal and external partners with focus on safety signal detecDon reports, process individual and aggregate safety data for clinical development, product quality issues, and pharmacovigilance metrics.

• Takes care of the safety database of the company.

• Responsible for regulatory aspects of creaDon, processing, and submission of DSURs and PSURs in cooperaDon with clinical team.

• CreaDng CAPAs to invesDgate and resolve quality issues. 2.Global pharma consultants LLC, Columbus, OHIO (2017-2021) Regulatory Consultant (part time)

• Responsible for regulatory support and documentation for the regulatory affairs department

(FDA).

• Worked related to reviewing and updating ANDA documents for more than 200 pharmaceutical capsules and tablets with current existing new requirements.

• AddiDonally reviewed animal medical devices with standards compared with FDA guidelines.

• Performed data entry with new technical funcDonality and generated documents with FDA guidelines.

• Troubleshoot document issues in MS word and Adobe Acrobat Pro.

• Documenting of handling, and approval of pharmaceutical products.

• Setting up of local records and continuous updates throughout submission approval process.

• Oversee quality control of regulatory documents and submissions. 2.Wipro Technologies, India (2008- 2009)

Programming applications -Software developer.

• Helped to design form validation programs using HTML and JavaScript.

• Assisted in maintaining and updating existing applications and modules.

• Support programming team members.

Education

• Master of Technology (MTech) in Industrial Biotechnology (India,2008) (GPA:9.57/10).

• Bachelor’s degree in biotechnology (India,2006).

• Diploma in computer programming.

• Advanced Post Graduate Diploma in Regulatory affairs (US,2020-2021).

• Advance Post Graduate Diploma in Clinical Research (US,2020-2021).

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