Management Project Manager

SAURAV ANEJA

Address: ***** ******* ****** *** ** 64, Hayward, California, 94544

Contact No: 317-***-****; Email: aczbdc@r.postjobfree.com; www.linkedin.com/in/sauravaneja88

Objective

To secure a full time position in a competitive environment that encourages research, learning and development; where I can effectively broaden and hone my skills as a professional regulatory personal.

Experience

Regulatory Affairs Associate (CMC) at Impax Laboratories Inc, Hayward (California) May 2015 – Present

Pre-Approval:

Assisting with several ANDA filings Updating eCTD template documents for ANDA Applications.

Drafting Complete Responses and Information Requests.

Filing Controlled Correspondence (IID Limits for Excipients and Q1/Q2 formulation).

Minor, Major and Telephone Amendments.

Post Approval:

Regulatory lead for 15 marketed Generic products (Capsules, Tablets and Injectables).

Ensuring a 100% compliance rate for regulatory submissions including Annual Reports PADERs.

Assessing and filing post-approval CMC changes (CBE-0, CBE-30, PAS).

Strategizing and driving the submission process to ensure regulatory compliance.

Assessing and categorizing manufacturing changes, analytical changes, DMF changes, packaging changes to comply with FDA filing category and compliance guidelines.

Independently handling several projects by engaging with contract manufacturers, API manufacturer, and contract packagers.

FDA Guidances:

Fully Versed with FDA’s guidances mainly pertaining to Generic Pharmaceutical Industry:

Content and Format of ANDA, Refuse to Receive standards, Self-identification of Generic Drug Facilities, Sites and Organization, 180 Day Exclusivity, Impurities in New Drug Product and New Drug Substance, Residual Solvents, SUPAC (IR and MR), Annual Reportable changes, CMC Post Approval changes Guidance, PAC-ATLS guidance.

Internship-IRB Company (IRB Analyst): [Jan, 2015 ~ April, 2015]

Evaluate IRB applications for completeness and conformance to regulations, guidelines. Alerts IRB Manager, Chair and Medical Director to protocol issues that may need closer review.

Internship-FDA: Food and Drug Administration: [May, 2014 ~July, 2014]

Metric/Cost of Quality - Improved access to digested data on status of quality products & vigilance process.

Pharmacovigilance/drug safety Associate, Apcer Pharma, New Delhi (India) June2010 - July2011

A post marketing surveillance involving meticulous processing of patient reports received from the client’s trial sites and marketed by abiding the standard operating procedures (SOP). Monitoring the adverse events, coding the events with the help of MEDRA, labeling the events according to the Company Core Data Sheet

Project Manager, National Rural Health Mission (NRHM); Govt. of India Feb 2013 - Dec2013

Management of human and financial resources under National health Program Scheme for below poverty line people (Food fortification project, Supply chain generic medicine project, essential medicine list).

Education

M.S Regulatory science, University Of Southern California, Los Angeles December, 2015

Related Course work: Medical Product Regulation, Clinical Trial Design & Statistics, Food and Drug Toxicology, Structure and Management of Clinical Trials, Regulation of Medical Devices, Regulations of Drugs & Biologics, Quality Systems and Standards, Medical Products and the Law, Chemistry Manufacturing and Controls, Global Regulations

M.B.A., Institute of Health Management and Research (IIHMR), India (WHO Collaborating, India) May 2013

Related Course Work: Health Economics, Biostatistics, Clinical Research, Financial management, Marketing management, Communication and Planning, Strategic management, Operation management, International health, Applied Epidemiology, Disaster and Risk management, Human resource management, Organizational behavior.

Bachelors in Pharmacy

M.M College of Pharmacy, Kurukshetra University, India May 2010

Related course work: Pharmacology, Pharmaceutics, Medicinal chemistry, Analytical chemistry

Projects

Comparative Analysis of ANDA (505j) and 505B (2) and issues surrounding Compulsory Licensing.

Developed a Target Product Profile(TPP) for a Rheumatoid Arthritis Drug which is under developing phase,

Comparative analysis of European Union and US Medical device regulations and approval process.

Project: Developed a Business plan for an approved drug for Arthritis which was never marketed and developed strategies for the successful re launch of the drug.

Clinical Research: Designing Phase 4 study for FDA approved drug, Bupripion for it’s off label use in obesity

Orphan drug Application route for a novel anti-cancer molecule that has evidence of efficacy in acute myeloid leukemia

Report on the adverse event reporting of a phase 2 study of new asthma drug which resulted in hospitalization of two subjects in emergency setting.

Proposed a regulatory strategy for the entry level company; as one of their products received a warning letter (483) in regards with non-compliance of their product with FDA requirements.

Regulatory Intelligence App: Regulatory app based on competitive intelligence is in design phase in collaboration with USC innovation team.

Computer Skills: Tools: MS Office, SPSS (statistical Package for social science), SAS (statistical tools)

Soft skills: strong work ethics, communication, analytical, business acumen, motivation, Creativity,

Finance and Accounting Skills: Profound Understanding of the financial analysis of the company Balance sheets, Equity, Shares, Bonds, Corporate Type(S corp. C Corp, LLC).

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