Saket Kanakdhar

As a seasoned professional with 4 years of experience in pharmacovigilance and corporate settings, I recently completed a 6-months Quality Operations Efficiency internship at Genentech. I worked for QA, gap analysis, and validation, with a strong focus on ensuring compliance with FDA regulations. I am now seeking a role as a Regulatory Affairs Associate in the biotechnology and medical device industries where I can leverage my skills to contribute to the growth of the organization.

I am writing to express my strong interest in the full-time position of Regulatory Affairs Associate with my background in quality assurance, gap analysis, and validation, along with a deep understanding of FDA regulations, I am confident that I possess the skills and expertise necessary to contribute to the growth of your esteemed organization.

Upon reviewing my resume, you will notice that I am driven by working for organizations that serve a higher purpose, which is why I am particularly drawn to its mission and vision. I am eager to bring my knowledge and experience to support your cause. Throughout my professional experience, I have honed my skills in regulatory research tools, including maintaining accurate documentation, data processing, regulatory documentation, and regulatory operations. I take pride in being reliable and dedicated, ensuring that I fulfill my responsibilities promptly and effectively. Additionally, I possess strong organizational skills, proactively address tasks, pay close attention to detail, and effectively manage my time.

I would like to draw your attention to a brief gap in my employment history. I made a deliberate decision to take a leave from the workforce to pursue a Master's degree in Regulatory Affairs. This period allowed me to enhance my professional growth significantly, and I am now eager to re-enter the professional sphere and apply my newfound qualifications and knowledge to excel in the role.

During my Master's program, I had the privilege of working as a Quality Operations Efficiency Intern at Genentech, a renowned biotechnology company. In this role, I gained hands-on experience in QA, gap analysis, and validation, with a primary focus on ensuring compliance with FDA regulations. This experience further fueled my passion for biotechnology and medical device industries, particularly in the areas of clinical trials, medical devices, biotechnology, cybersecurity, as well as quality and compliance domains.

Please find attached my resume, which provides additional details regarding my work experience and qualifications. I am confident that my dedication, expertise, and passion for regulatory affairs make me an ideal candidate for the position I welcome the opportunity to discuss how my skills can contribute to your organization's success in more detail.

Thank you for considering my application. I look forward to the possibility of discussing my candidacy further.

Sincerely,

Saket Kanakdhar

EDUCATION__________________________________________________________________________________________________________________________________________________________________________ NORTHEASTERN UNIVERSITY, Boston, MA (GPA- 3.69/4.0) Sep 2021 – Jul 2023 Masters in Regulatory Affairs for Drugs, Biologic and Medical Devices Relevant Courses: Risk and Quality Management, Human Experimentation, Regulatory Strategy for Product Development & Lifecycle Management, FDA Medical Device Regulation, Legal Issues in Regulation, Medical Device Development, Safety Sciences, Project Management for regulatory affairs, of Global regulatory Affairs Practical application, Cybersecurity and Regulation of Digital Health Technologies, Product Development and Process Validation. PUNE UNIVERSITY, Pune, INDIA (GPA- 3.5/4.0) Jul 2012 - Jun 2016 Bachelor of Pharmacy Relevant Courses: Pharmaceutical Jurisprudence, Biopharmaceutics, Clinical Pharmacy, Pharmacology, Biotechnology, Quality Assurance, Industrial & Pharmaceutical Engineering, Medicinal Chemistry, Bio-Organic Chemistry & Drug Development.