Priyam Prasad
Regulatory and Quality Intern @ Akriti Pharmaceuticals Pvt Ltd
About
I am a regulatory affairs graduate student at Northeastern University with a strong foundation in U.S. FDA regulatory frameworks, global regulatory strategy, and pharmaceutical product lifecycle management, complemented by hands-on experience in community and institutional pharmacy settings.My regulatory background includes academic and practical exposure to IND, NDA, BLA, ANDA, and post-market surveillance activities, with experience supporting regulatory documentation, compliance analysis, and case-based regulatory strategy development aligned with FDA regulations, ICH guidelines, and global standards.I have gained frontline healthcare experience through community pharmacy roles at Walgreens and CVS, where I supported high-volume prescription processing, patient counseling, immunization services, inventory management, and direct patient communication. These experiences strengthened my understanding of medication use systems, patient safety, and real-world regulatory compliance at the point of care. Combined with institutional exposure at Boston Medical Center and early regulatory training in an international pharmaceutical manufacturing environment,I bring a well-rounded perspective that bridges regulatory strategy with clinical operations, data integrity, and compliance-driven decision-making across the pharmaceutical lifecycle.
United States
Greater Boston
Higher Education
Problem Solving, Strategic Planning, Communication, Pharmaceutics, Hindi, Health Sciences, Teaching, English, Microsoft Office, Research, Team Leadership, Team Building, Opportunity Identification, Problem Solving , Presentation, Poetry
Experience

Regulatory and Quality Intern
Thane
●Supported ANDA/NDA-style regulatory submission requirements for generic drug products through documentation review, data validation, and submission readiness activities. ●Verified Drug Substance (DS) and Drug Product (DP) manufacturing site information, assisting with accuracy of establishment data, including site identifiers and applicant holder details used in regulatory records. ●Maintained product master lists and regulatory tracking logs using Microsoft Excel, supporting data reconciliation, version control, and documentation accuracy. ●Reviewed and organized regulatory submission documents in an eCTD-style structure, supporting sequence organization, archival, and document completeness checks. ●Performed regulatory document control and archival activities, ensuring traceability and readiness of submission-related records. ●Assisted with regulatory correspondence organization and routing, supporting timely communication between regulatory, quality, and manufacturing teams. ●Contributed to preparation and maintenance of Drug Product History Files (DPHFs) as part of documentation standardization initiatives. ●Supported change control documentation reviews and assisted with basic regulatory impact assessments in collaboration with quality and manufacturing teams. ●Gained exposure to EU-GMP and international regulatory expectations, including review of quality documentation, manufacturing records, and compliance practices aligned with global regulatory standards

Pharmacy intern
Boston, MA
●Worked in Central Pharmacy and assisted in pull and Bag process ●Delivered meds around the hospital to refill the pyxis system ●Prepared IV bags ●Worked in sterile room to prepare meds ●Hand on training with epic system to observe the patient Profile and look for drug drug interaction

Admission ambassador
Boston, MA
●Prospective Student Engagement: Conducted meetings with prospective students and families, offering insights into MCPHS programs and student life ●Public Speaking and Presentation: Participated in information sessions and college fairs, providing an informed and positive representation of MCPHS. ●Personalized Outreach: Sent congratulatory notes to accepted students, contributing to a welcoming and supportive admissions process. ●Experience Sharing: Shared personal experiences from international service trips, clinical rotations, and clerkships, helping prospective students ●Content Creation: Developed blogs and participated in panels, offering a real perspective on studying abroad and campus experiences. ●Community Building: Actively contributed to MCPHS’s reputation and outreach efforts, helping build a strong and inclusive campus community. understand unique opportunities at MCPHS

President,SGA(Student Government Association)
Boston, MA
●Met with the president and provost of MCPHS to discuss various bills ●Representation: Acted as the chief liaison and voice for student interests, representing the student body in communications with administration. ●Meeting Facilitation: Led and presided over SGA and Executive Board meetings, ensuring organization, agenda setting, and maintaining order. ●Team Building and Delegation: Appointed and guided Executive Cabinet, Student Judiciary, and student representatives for college committees, enhancing team structure. ●Financial Management: Oversaw and reconcile financial records, ensuring treasury audits and budget accuracy. ●Decision-Making Authority: Exercised responsibility as a tiebreaker, making decisive judgments in critical situations. ●Community Engagement: Maintained strong communication with the student body, support services, and advisor, actively participating in SGA events. ●Professional Communication: Managed official SGA correspondence, maintaining a professional channel for student government affair Important activities in Student Government President: ●Aunt Flow Bill:Installed menstrual pads in girls washroom ●Collaborative Study Spaces:Got extra spaces for students to have recreational spaces and extra study spaces ●Town Hall:Conducted one of the biggest town hall in MCPHS with more than 120 students and deans of different department under one room to talk about their respective school and address student questions. ●Scooter Parking bill:Worked with public safety to get a scooter parking for commuter students

Peer Mentor,ULN(University Learning Network)
Boston, MA
●Supported the freshman students ●Attended Welcome Days on the Boston campus ●Participated in the Introduction to the Major (ITM) course ●Planned co-curricular activities for ITM in the fall semester ●Became a bridge of transition between students and faculty ●Introduced students to campus resources and conducted one on one meeting sessions to make sure students are well settled in school ●Worked with other peer mentors to and collaborated with them learning and interactive sessions for mentees

Student Government Association Clerk,SGA(student Government Association)
Boston, MA
●Served as a subordinate to SGA Vice President in conducting senate meeting ●Kept track of all SGA bills and senate updates Collaborating with others SGA members collaborate with other SGA members, faculty, and staff to improve the student experience. ●Participating in events SGA members attend general body meetings, town halls, board meetings, and other events. ●Supporting the Office of Student Life and SGA members assist with projects, presentations, and events such as New Student Orientation and Welcome Week. ●Submitting logistical needs ●SGA members submit logistical needs for SGA-sponsored initiatives, such as room reservations and event set-up requests

Orientation Leader,Center of Campus Life
Boston, MA
●Facilitated welcoming and engaging orientation sessions for incoming students, ensuring a smooth transition to university life. ●Provided mentorship and guidance to new students, fostering a sense of community and belonging. ●Collaborated with other orientation leaders and staff to organize and execute campus-wide events, enhancing student engagement and participation. ●Conducted campus tours and informational sessions, effectively communicating key resources, programs, and campus policies to new students. ●Managed group activities and icebreakers to encourage team-building and interpersonal connections among students. ●Addressed students' questions and concerns, offering support and resources for academic and social challenges. ●Developed leadership, public speaking, and communication skills by guiding diverse groups of students through orientation programming. ●Acted as a liaison between students and university administration, ensuring student feedback and needs were communicated effectively.

Senator,SGA(Student Government Association)
Boston, MA
●Committee Participation: Served on student life committees as needed, providing input and helping to carry out SGA initiatives across various campus sectors. ●Effective Communication: Maintained communication between the SGA, student body, and administration, relaying information and gathering feedback. ●Collaboration and Teamwork: Worked alongside other SGA members to foster a collaborative environment focused on enhancing student experience. ●Worked on bills like student transparency bill which allowed students to get complete breakdown of their financial statements

Peer Tutor
Boston, MA
●Provided academic support and tutoring to peers in in calculus and chemistry, enhancing their understanding and retention of material. ●Facilitated study sessions and engaged students in active learning techniques, improving their comprehension and confidence. ●Collaborated with instructors to ensure alignment of tutoring sessions with course objectives. ●Developed and tailored study materials, including summaries, practice questions, and visual aids, to suit diverse learning styles. ●Encouraged a collaborative and supportive learning environment, fostering peer connections and academic growth. ●Demonstrated strong communication and interpersonal skills to explain complex concepts in a clear, relatable manner. ●Received positive feedback from students and faculty for contributing to improved academic performance and engagement.

Pharmacy Intern
full time
●Reviewed and verified all patient information and accurately recorded said information into required systems ●Prepared and administered various vaccines to patients and provided appropriate counseling. ●Accurately obtained and filled a high volume of patient prescriptions promptly ●Communicated to patients in person and over the phone to ensure they received the correct medication. ●Communicated to patients in person and over the phone to discuss eligibility of vaccine ●Recorded inventory and placed medication into the appropriate location ●Scheduled patients for upcoming vaccine appointments ●Verified inventory inside controlled medications safe to ensure perpetual inventory is up to date ●Called health care facilities to request updated prescriptions are sent to the pharmac

Trainee
Thane
• Assisted in the preparation of regulatory documentation, ensuring compliance with EU-GMP, TGA, and Indian FDA standards. • Collaborated with regulatory teams to maintain accurate electronic and physical records for audit readiness. • Developed mock IND Safety Reports and protocol amendments, aligning with FDA expectations to enhance regulatory understanding.
Priyam Prasad's Contact Information
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