Welcome Guest

Medical >> Drug Regulatory Affairs Executive 
Regulatory Manager Resume Sample, Experience : 8 years

Sponsored Links:


Name of the Candidate:[Private]
Name of the Post Applied:Regulatory Manager
Job related skills / software:Communicating with global marketing persons & technical consultant to resolved the issue piled up during the Process of new & renewal marketing authorization & preparation of documents. - Resolve NOD raised by concerned regulatory agency up to satisfaction
Sub Category:Drug Regulatory Affairs Executive
Years of Experience:8 years
Salary Expected per Month(Rs):70,000 to 80,000
Highest Qualification attained:B.Pharma
Major / Specialization:Pharmacy
Email Id:[Private]
Are you looking for job now?:Yes
Can the recruiter contact you?:Yes
Sponsored Links:

Resume Format / CV Sample Template / Example / Model :


Manoj Singh
E-Mail  :mnjbhandari46 AT gmail.com
Mobile :+7015142023, +91-7417015355

Seeking assignments inRegulatory Affairs with an organization of repute

** 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

Presently (since June.2017) working as Manager – Regulatory Affairs, at Saitech Medicare Pvt. Ltd. H.P.,

** 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.

One week eCTD dossier training for Europe & US from Extedo eRegulatory Affairs Germany.

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.

Well versed with handling and calibration of analytical instruments like HPLC, HPTLC, GC, IR, UV, Analytical Balance & Dissolution &.Disintegration Time Apparatus and pH meter

** 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.


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,

Bachelor of Pharmacy From Dehradun Institute of technology Uttarakhand.

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

** 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.



1. This is an online resume, managed by the candidate.
2. Create your online resume here.
3. If candidate allows, recruiters can contact the candidate directly.
4. Personal and contact details can be kept private optionally by the candidate.
5. Create a link to this online resume where ever you want in the web.