Deep Shah

*** **** ******, ******. ** *****

Email ab2pmh@r.postjobfree.com, Phone 617-***-****

OBJECTIVE

Regulatory affairs professional with strengths including negotiation, problem solving and benefit risk analysis,

seeking an entry level position to contribute to the growth of your organization by utilizing my educational skills

with the best use of my determination and dedication.

EDUCATION

Northeastern University, Boston, Massachusetts June 2013

Masters in Regulatory Affairs for Drugs Biologics and Medical Device

Relevant Courses: Introduction to Drug and Medical Device Regulation, New Drug Development Regulation,

Regulatory Overview of Biologics Development, Human Experimentation, Medical Device Regulation, FDA

Submissions, EMA/MHRA submissions, Canadian Regulatory Affairs.

Gujarat University, India June

2011

Bachelors in Pharmaceutical Science

Relevant Courses: Pharmaceutics, Biotechnology, Pharmaceutical Analysis, Biopharmaceutics and

Pharmacology, Clinical Pharmacy, Forensic pharmacy, Quality Assurance.

EXPERIENCE

Elite Pharma Pvt. Ltd., Ahmadabad, India QA/RA Intern Jan 2011 May

2011

• Assisted in compilation of regulatory submission and documentation packages through various

departmental policies.

• Performed quality check of finished products as per standard operating procedures.

• Maintained database of auditable regulatory documents and ensured product compliance with

regulations.

• Assisted in effective database management and performed data entry as per the standard procedures.

• Prepared technical documents and ensured compliance with guidance documents.

• Assisted in quality control tests for tablet hardness/fragility, pH testing, chromatographic testing and

other in process Q/C tests.

• Performed documentation tools like hyper linking/bookmarking, assembling and performed Quality

Check of regulatory documents ready for FDA submission in paper and electronic format.

• Acquired basic knowledge on software like eCTDManager and insight publisher for internal and

external electronic publishing and FirsDocs for document management system.

PROJECTS AT NORTHEASTERN UNIVERSITY

Canadian medical device license application for class III device (patient monitors) March 2013

• Submitted a Canadian medical device application for fiction patient monitors (class III device) which are

used for physiological patient monitoring (OIRATNO Patient Monitor).

• Prepared a detailed layout of Bio compatibility statement, Canadian Standards summary, design

philosophy, safety and effectiveness summary table and declaration of conformity.

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NDA application for fictional Dopamine tablet (DopaTAB) October 2012

• Submitted a presentation concerning Pre IND meeting agenda for DopaTAB.

• Submitted a 365h form of new drug application for DopaTAB along with required information.

• Prepared a detailed submission dossier containing table of contents, summary, chemistry section

including CMC, nonclinical and clinical sections for dopamine, clinical microbiology section, safety

update report, patient information etc.

Deep Shah

110 Ward Street, Boston. MA 02120

Email ab2pmh@r.postjobfree.com, Phone 617-***-****

PROJECTS AT NORTHEASTERN UNIVERSITY

510(k) Submission for fictional neurovascular Catheters June 2012

• Prepared a descriptive 510(k) application for fictional neurovascular catheters based on guidance

documents provided in 21 CFR 812 &814.

• Prepared a detailed paper on all 21 sections for 510(k) submission including 510(k) summary, executive

summary, device description, biocompatibility, substantial equivalence comparison, proposed labeling,

electromagnetic compatibility, performance testing etc.

BLA application of Hemacord (Team Project) April

2012

• Reviewed product specific FDA guidance documents, preclinical safety data & clinical investigation plan

for specified product, chemistry, manufacturing & control data and pre market submission criteria for

biological product ‘Hemacord’ along with form 356h.

• Drafted a position paper on the sequence of processes involved in the BLA application of Hemacord.

IRB Case Scenario

December 2011

• Prepared sample informed consent in compliance with 21CFR 50 and 56 based on the clinical

studies given in ClinicalTrials.gov

SKILLS

Computer Skills

:

• Proficient in Microsoft Office with sound knowledge about Microsoft Word, Outlook, PowerPoint, Excel,

Visio and Share point.

• Good experience with Professional Adobe Acrobat, ISI Toolbox, hyper linking and bookmarking.

Regulatory Skills:

• Knowledge of ISO 9001, ISO 13485, quality management systems and GHTF/IMDRF guidelines, Annual

reports & Protocol amendments.

• Understanding of IND/NDA/ANDA for drugs & BLA for biologics.

• Overview of premarket approval, 510K submission, STED/HDE for medical devices.

• Clinical trial application, IRB, informed consent for clinical trials.

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• Post market surveillance, CAPA, Risk management, promotional literature, complaint investigation.

• ICH Submission readiness standards.

Organizational and Management Skills:

• Managed and coordinated all the events for the Indian Community at Northeastern University as a

responsible Vice President of it.

CERTIFICATIONS/ACHIVEMENTS

• Registered Pharmacist Indian Pharmacy Council

• Active member of Regulatory Affairs Professional Society.

• Served as a responsible Vice President of Indian Social Community at Northeastern University for year

2012 13.

REFERENCES

References will be available upon request.

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