CURRICULUM VITAE :
Manoj Singh
E-Mail :mnjbhandari46 AT gmail.com
Mobile :+7015142023, +91-7417015355
Seeking assignments inRegulatory Affairs with an organization of repute
PROFESSIONAL SUMMARY :
** Offering more than 8.0 years of experience in preparation, review & submission of registration document/ Dossier for registration in international market and emerging (ROW) countries based on CTD/ACTD format & as per country specific requirements. Key knowledge areas are as follow.
** Resolve NOD (Notice of deficiency) raised by concerned agency up to satisfaction
** Communicate effectivelywith regulatory authorities of the region of responsibilities through our co-promoters in these regions to obtain timely product approvals.
** Well versed with ICH quality guideline CTD , ACTD format
** Registration of pharmaceuticals in international markets (ASEAN,AFRICA, LATAM, CIS, PIC/S based country)
** Proven ability in Registration of various pharmaceutical products in Emerging, PIC/S & WHO GENEVA based market.
** Effective communicator with excellent team building, management & motivation skills; problem solving & organizational abilities
PRESENT PROFILE :
Presently (since June.2017) working as Manager – Regulatory Affairs, at Saitech Medicare Pvt. Ltd. H.P.,
AREAS OF EXPERTISE :
** Manage transposition of international standards into company product related requirements.
** Communicating with global marketing persons & technical consultant to resolved the issue piled up during the Process of new & renewal marketing authorization & preparation of documents
** Responsible for coordination & preparation of regulatory submissions and strategies for new/renewal & variation filing and manufacturer full registration.
** Resolve NOD raised by concerned regulatory agency up to satisfaction.
** Review Product development report, Optimization protocol, Optimization Report, Stability protocol, stability report for Dossier Compilation.
** Review of Exhibit batch protocol, Exhibit batch report and Exhibit batch manufacturing record.
** Review of process validation protocol and process validation report.
** Preparation and review of ROW documents and submission of documents to Regulatory affairs.
** Review Analytical method verification & validation protocol & Report as per ICH Guideline
** Handling of post authorization activity & filling variations dossiers as per variation Guideline
** Preparation of SPC/ package insert /PIL leaflets and to coordinate with art work Department for art work, foil & pack insert
** Review of art works for Dossiers
** Review DMFs (Drug Master files)
** Co-ordination with concerned department for collection of various technical documents Required for Registration.
** Archival of technical & administrative documents received from various department
** Sample Arrangement & prepare legal documents required for products registration of the respective country
** Search & review relevant published literature related to clinical & Non clinical Data
** Registration and variation details transfer to manufacturing facility.
TRAINING :
One week eCTD dossier training for Europe & US from Extedo eRegulatory Affairs Germany.
PREVIOUS ORGANISATIONAL EXPERIENCE :
Since June.2016 to May 2017 worked as Asst.
Manager – Regulatory Affairs, at Naari Pharma Private Limited (Subsidiary of Jagsonpal Pharmaceuticals) Noida Uttar Pradesh. (EU, ANVISA, PIC/S, FMHACA (Ethiopia), NDA (Uganda) Regulated & Others Semi Regulated Approved GMP Plant at Rudrapur Uttarakhand)
Since Feb. 2015 to May 2016 : worked as an Executive at Acme Generics LLP; Himachal Pradesh
Since March. 2012 to January 2015 : Worked as Officer in DRA department at Psychotropics India Limited., Haridwar Uttarakhand.
Since May 2010 to March. 2012 : worked as officer in Quality Control department at Ranbaxy Labs Ltd., New Delhi.
HANDLED TOOLS & TECHNIQUES :
Well versed with handling and calibration of analytical instruments like HPLC, HPTLC, GC, IR, UV, Analytical Balance & Dissolution &.Disintegration Time Apparatus and pH meter
ACHIEVEMENTS DURING PROJECT :
** Exposure to regulatory guidelines of respective countries during dossier preparation.
** Interaction with foreign delegates with respect to the implementation of their regulatory norms.
** Co-ordination & management skill development during document collection and project handling.
DOSSIER EXPOSURE IN VARIOUS COUNTRY :
Who-Geneva
PIC/S :
Malaysia, Taiwan & Ukraine.
Asean Country :
Philippines, Vietnam, Cambodia, Myanmar, Laos PDR, Yemen & Sri Lanka,
African countries :
Niger, Mali, Senegal, Ivory Coste, Cameroon. Gabon, Burkina-Faso, Benin, DR Congo, Tanzania, Zanzibar, Uganda, Rwanda, Kenya, Nigeria & Ethiopia, Zimbabwe, Mozambique, Zambia, Madagascar, Ghana & Sierraleone.
Latin American Country :
Dominicans republic, Guatemala, Uruguay, Paraguay Columbia. Chile, Argentina, Bolvia, Peru, Ecuador & EL Salvador.
CIS :
Uzbekistan, Kyrgyzstan, Tajikistan, Belarus,
EDUCATION QUALIFICATION :
Bachelor of Pharmacy From Dehradun Institute of technology Uttarakhand.
PERSONAL DETAILS :
Father's Name : Mr. M.S Bhandari
Mother's Name : Mrs. Prabha Devi
Permanent Address : Village & post office Aleru, Patti Juwa, Tehri Garhwal (U.K.)
Marital status : Married
Date of birth : 11 January, 1985
Contact Details : 91+ 07015142023,+91-7417015355
Preferred Location : North India
PERSONAL SKILLS AND ABILITIES :
** Active Learning, listing and Monitoring
** Complex Problem Solving
** Time managements
** Coordination
** Judgment and decision making
** Working hard and honest person with good logical thinking.
** Positive attitude having good leading skill.
** Proactive team member and ready to take up new challenges.
** Dedicative sincere and flexible to work in any environment.
DATE :
PLACE :