PRIYANK SRIVASTAVAContact: +91- 8882524228, +91-9625364839 E-mail: priyanksrivastva@gmail.com

REGULATORY AFFAIRS PROFESSIONALSeeking a challenging and rewarding management position in the field of Regulatory Affairs to help the company in achieving quality objectives & growth and earn job satisfaction & recognition.

PROFESSIONAL EXPERIENCEDesignation: Regulatory Affairs Specialist. May 2012 to PresentCompany Name: Accredited Consultants Private Ltd., Delhi.Company Profile: Complete Regulatory Consultancy service provider for Drugs, Medical Devices, Diagnostic Kits,

API’s, Cosmetics and Food Products etc. (www.acplgroupindia.co.in)Designation: Quality Assurance & Quality Control Head. May 2010 to April 2012Company Name: Real Chemsys Products (P) Ltd, Noida.Company Profile: Fine Organic & Inorganic chemicals, Intermediates, HPLC & Dried/ Anhydrous solvents and

Laboratory reagents, Stains & Indicator manufacturer. (www.realchemsys.com)CORE COMPETENCIES

Professional service mentality – willing to go beyond the call of duty to satisfy their clients. Commitment to highest quality outputs, including obsessive attention to detail. Enthusiasm and pro-activity. Team collaborators, ability to be successful working in team.

KEY RESPONSIBILITIES AS REGULATORY AFFAIRS SPECIALIST Ensure professional planning with High proficiency, full regulatory compliance with all regulations, codes and

standards for efficient registration of Medical Devices, Diagnostic Kits, Drugs and Cosmetics. Review and Compilation of Applications and Registration dossiers & Master documents etc., Responsible for

sustaining excellent standards of the regulatory documents through comprehensive reviews. Develop and execute regulatory plans for complex projects, new registrations and maintenance of existing

licenses. Contribute to special assigned activities and projects, or represent Regulatory Affairs in cross-

functional assignments and projects. On-site Regulatory Services for Medical Devices and Diagnostics. Review and Development of artworks & labeling as per requirements of Drugs & Cosmetic Act Rules (Rule 96). Review & approval of Promotional Material and Patient Information Leaflets. Handling deficiencies arising from Regulatory Authorities and resolving the queries as requested by the

Customers and Regulatory Agencies. To co-ordinate and provide periodic update of the interactions with drug authorities for the registration/renewal of

certificates and Responses to Health Authorities queries. To prepare the prescribing information and abbreviated prescribing information for the products.

KNOWLEDGE AND SPECIALIZATION: Specialization in Medical devices specially Orthopedics, Cardiac and Dental Implants with other Devices. Worked with Class II and Class III devices extensively. Sound knowledge of ICH guidelines; CTD: Module 1 to Module 5.

Submission requirements of various markets such as USFDA, EMEA, Emerging/ROW etc.

Maintain knowledge and understanding of regulatory requirements in region of responsibility Developing Regulatory Strategy, Regulatory Compliance and Training to team.

Exposure in basics of ICH-GCP, ICMR guidelines, GMP, Schedule Y, Drugs and Cosmetics act and rules 1940.WORK PROFILE INCLUDES:Drugs & API’s:

New Drug Approval’s (NDA and ANDA Filings), Registration, Import License from Central Drug Standard Control Organization New Delhi (CDSCO).

Test License, No Objection Certificates for export, CoPP Applications etc. from Zonal FDA. Free Sale Certificates, CoPP, Manufacturing License, Manufacturing Permissions, WHO GMP, Warehouse

License from State FDA.Biologicals:

New Drug Approval, Registration, Import License from Central Drug Standard Control Organization New Delhi (CDSCO)

Clinical Trial Permissions from Indian Council of Medical Research (ICMR), New Delhi Permissions for Import & Export of Biologicals from Indian Council of Medical Research (ICMR), New Delhi

PRIYANK SRIVASTAVAContact: +91- 8882524228, +91-9625364839 E-mail: priyanksrivastva@gmail.com

R&D Approval from Department of Science and Industrial Research (DSIR).

Medical Devices & IVD’s: New Devices Registration (NDA Filing), Registration, Import License from Central Drug Standard Control

Organization New Delhi (CDSCO). Test License, No Objection Certificates for export etc. from Zonal FDA. Free Sale Certificates, CoPP, Manufacturing License, Manufacturing Permissions, WHO GMP, Warehouse

License from State FDA. On-site Regulatory Services for Medical Devices and Diagnostics. Equipment Type Approval and Import License for the wireless devices viz. Cardiographs and Monitoring Devices

from Wireless Planning & Coordination Wing, Department of Telecommunications (WPC) Permissions for Import of Re-furbished Machines from Ministry of Environment Permissions for Import of Batteries for Medical Instruments from Pollution Control Board Clinical Trial Permissions from Indian Council of Medical Research (ICMR), New Delhi Performance Evaluation Report for Critical Diagnostic Kits viz. HIV, HBsAg, HCV and Blood Glucose Monitoring

Strips from National Institute of Biologicals (NIB) R&D Approval from Department of Science and Industrial Research (DSIR).

Nutraceuticals: New Product Registration and Central License from Food Safety Standard Authority of India (FSSAI) Registration, State License and Manufacturing License etc. from State Food Safety Standard Authority.

Concern Departments: CDSCO, New Delhi Zonal and Local Drug Authority (FDA) Wireless Planning & Coordination Wing,

Department of Telecommunications (WPC) National Institute of Biologicals (NIB)

Ministry of Environment Pollution Control Board Indian Council of Medical Research (ICMR) Department of Science and Industrial Research (DSIR). Food Safety Standard Authority of India (FSSAI)

KEY RESPONSIBILITIES AS QA AND QC HEAD Quality Head & responsible for managing the operations of Process, Projects, Materials, Engineering, Packing &

Administratively QA/QC etc. Maintain the facilities in conformance to cGMP’s and other regulatory requirements of the markets and to keep

them in validated state Accountable for auditing, upgrading and harmonizing Systems, SOP's, Documents, including validations, to meet

the required cGMP, ISO standards To efficiently use the resources to meet production targets and be competitive in terms of quality and efficiencies

with the best in the industry Implementation of cGLP Quality control of raw Materials Quality control of finished products Ensure all testing performed and Approve

specifications

Approval or rejection of materials Maintain department, premises and records Inspection, investigation, and taking samples Evaluate batch records Initial and ongoing

trainingEDUCATIONAL CREDENTIALS

Master of Pharmacy (Pharmaceutical Chemistry) 2010I.T.S. Pharmacy College, Ghaziabad

Bachelor of Pharmacy 2008R.R.S. College of Pharmacy, Amethi

CO-CURRICULAR ACCOLADES GATE Score 2008, 81.53 percentile (Graduate Aptitude Test for Engineering and Pharmacy) Advanced Diploma in Computer Software and Applications Participated in Indian pharmaceutical congress in 2007 held at B.H.U., Varanasi as a volunteer Participated in Indian pharmaceutical congress in 2009 held at New Delhi

PERSONALFather’s Name : Late Hari KrishnaAddress : 167/1A, Mandir Lane, Sarai Jullena, New Friend’s Colony, New Delhi 110025.Mobile : +91-8882524228, +91-8285599325

PRIYANK SRIVASTAVAContact: +91- 8882524228, +91-9625364839 E-mail: priyanksrivastva@gmail.com

Email : priyanksrivastva@gmail.comPassport No : Z2128505 Valid up to 04-01-2022References : Available on request.

Priyank Srivastava New Delhi