Manoj Kumar Verma Permanent Address

E. mail: ac2feb@r.postjobfree.com WZ- 1247 Rani Bagh

Tel. : +91-987******* Delhi- 110034

INDIA

CAREER OBJECTIVE

Aspiring for a position as a Manager in a leading industry with a dynamic and amiable work environment; providing opportunities for growth and value addition. Willing to contribute towards growth of the organization by utilizing my professional and managerial capabilities.

PROFESSIONAL EXPERIENCE

Jan. 2014 Onwards

Manager-II – Regulatory Affairs

Fresenius Kabi Oncology Limited

Aug. 2013 – Jan. 2014

Manager – Regulatory Affairs

Wockhardt Limited

Sep. 2011 – Jul. 2013

Manager – Regulatory Affairs

Promed Exports Pvt. Ltd

Apr. 2011 – Sep 2011

Manager – Regulatory Affairs

Bal Pharma Limited, New Delhi

Jan. 2008 – Mar. 2011

Senior Research Scientist - Drug Regulatory Affairs (R & D Centre, Gurgaon)

Ranbaxy Laboratories Limited.

Also, worked in Ranbaxy, USA office for two months.

Aug. 2006 – Dec. 2007

Research Scientist –Drug Regulatory Affairs (R & D Centre, Gurgaon)

Ranbaxy Laboratories Limited.

- Also, worked in Ranbaxy, USA office for three months.

Aug. 2004 – Aug. 2006

Research Associate–Drug Regulatory Affairs (R & D Centre, Gurgaon)

Ranbaxy Laboratories Limited.

JOB PROFILE AND KEY RESPONSIBILITIES at FRESENIUS KABI ONCOLOGY LIMITED

{Dosage Forms: Solid Oral Dosage Forms & Sterile solutions (Injectables)}

I am working in the capacity of Regulatory Affairs Manager handling a team of 6 members, solely responsible for filings globally (i.e USA. Canada, Europe, ROW countries)

Key Roles and Responsibilities:

Team management and mentoring activities.

Planning, Monitoring and review of dossiers of formulations ; ensuring adequacy and accuracy before compilation/submission of dossiers

Providing regulatory support and guidance to the Product Development and Research Department.

Maintaining registration certificates & records of registered products for renewal.

Serving as a liaison between key departments such as technical, production, packaging quality and foreign offices of the organization etc to ensure projects are submitted on time.

Providing guidance on setting up of raw material, drug substance and drug product specifications.

Maintaining a project plan; timelines and check points, logical links between activities to ensure timely submission of dossier/responses to the regulatory Agencies.

Participating in project team meetings and providing the regulatory status of the projects under review for timely launch of the drug product and updating the group with regulatory requirements in case of new development products.

Participating in regional regulatory team meeting and updating the status the Oncology products to counterparts across the globe.

Proving inputs in the vendor qualification for API procurement.

Tracking the pharmacoepial revision/updation of the monographs and ensuring the compliance of specifications.

To review and finalization of Documents, Specifications, Batch Production Records, Process Validation Protocols and Stability data etc.

Providing guidance to plant people for any kind of regulatory issues.

Compilation and filing of Amendments, Life cycle management.

Knowledge of eCTD filing and regulatory database.

Monitor change control proposal to eliminate non-compliance risks. Ensuring pre and post approval compliance.

Other activities involve filing of Controlled correspondences and Bio correspondence, Suitability Petitions with USFDA.

Preparation of department budget and evaluating the need of department SOPs (if any)

JOB PROFILE AND KEY RESPONSIBILITIES at WOCKHARDT

(Dosage Forms: Solid Oral Dosage Forms & Liquid Oral Dosage Forms)

At Wockhardt, I was working in the capacity of Regulatory Affairs Manager handling a team of 4 members, solely responsible for USA, Europe & CANADA filings.

Key Roles and Responsibilities:

Team management and mentoring activities.

Planning, Monitoring and review of dossiers of formulations ; ensuring adequacy and accuracy before compilation/submission of dossiers

Job involves coordination with support departments like analytical, Clinical Pharmacology and Pharmacokinetics, Quality Assurance, Quality Control, production facilities, foreign offices of the organization etc for ANDA/ANDS submission.

Tracking the pharmacoepial revision/updation of the monographs and ensuring the compliance of specifications.

To review and finalization of Documents, Specifications, Batch Production Records, Process Validation Protocols and Stability data etc.

Providing guidance to plant people for any kind of regulatory issues.

Compilation and filing of Amendments, Post Approval Supplements, Annual Reports with USFDA.

Knowledge of eCTD filing

Monitor change control proposal to eliminate non-compliance risks. Ensuring pre and post approval compliance .

Other activities involve filing of Controlled correspondences and Bio correspondence, Suitability Petitions with USFDA.

JOB PROFILE AND KEY RESPONSIBILITIES at PROMED EXPORTS PVT. LTD

(Dosage Forms: Sterile Solutions i.e Opthalmic, Otic & Inhalation solutions and Solid Oral Dosage Forms)

At Promed Exports Pvt. Ltd, I was working in the capacity of Regulatory Affairs Manager handling a team of 8 members, solely responsible for following countries/regions:

USA, Europe, Canada and ROW.

Key Roles and Responsibilities:

Team management and mentoring activities.

Planning, Monitoring and review of dossiers of formulations ; ensuring adequacy and accuracy before compilation/submission of dossiers

Providing guidance and assistance to R & D team with relevant information on various studies required for USA, Europe, Brazil, Australia, Canada etc filings.

Responding to technical queries received from drug regulatory authorities and business partners of respective countries for registration of products.

Extending complete technical support to the business/marketing team by submitting Registration Dossiers timely to obtain international market clearances.

Strategy planning to enter new markets with assistance from business development team considering regulatory requirement.

Pre & post approval compliance as per various regulatory authorities.

SOP preparation and review to maintain the quality aspects.

Manage/prepare department budget

JOB PROFILE AND KEY RESPONSIBILITIES at BAL PHARMA LIMITED

(Dosage Forms: Solid Oral Dosage Forms, Liquid Oral Dosage Forms and Semi Solid Oral Dosage Forms)

At Bal Pharma Limited, I was working in the capacity of Regulatory Affairs Manager heading the department; solely responsible for following countries/regions:

USA, Europe, Asia, Middle East, Africa, Central & Latin America.

Key Roles and Responsibilities:

Inception and organization of the Regulatory Affairs function at its Delhi office, managing the Semi-regulated, non-regulated markets and the proposed USA, Europe, Brazil, South-Africa markets.

Planning, Monitoring and review of registration and re-registration dossiers of formulations for semi- regulated and non-regulated countries; ensuring adequacy and accuracy before compilation/submission of dossiers

To facilitate quick response to technical queries received from agents and health authorities of respective countries for registration of products.

Co-ordination with quality assurance, quality control, R & D, packaging, and production departments for technical data and samples.

Team management and mentoring activities.

Maintaining registration certificates & records of registered products for renewal.

Assessing /reviewing documentation to ensure compliance with product licenses.

Checking for artwork development of packing material for product.

JOB PROFILE AND KEY RESPONSIBILITIES at RANBAXY

(Dosage Forms: Solid Oral Dosage Forms & Liquid Oral Dosage Forms)

At Ranbaxy, I was solely responsible for USA and Canada filings.

Preparation, review and submission of ANDA’s/ANDS’s to the USFDA/TPD (Therapeutic Products Directorate, Canada) and providing regulatory support and guidance to the Product Development and Research Department.

Job involves coordination with support departments like analytical, Clinical Pharmacology and Pharmacokinetics, Quality Assurance, Quality Control, production facilities, foreign offices of the organization etc for ANDA/ANDS submission.

Providing guidance on setting up of raw material, drug substance and drug product specifications.

To review and finalization of Documents, Specifications, Batch Production Records, Process Validation Protocols and Stability data etc.

Providing guidance to plant people for any kind of regulatory issues.

Compilation and filing of Amendments, Post Approval Supplements, Annual Reports with USFDA.

Team member for validation of eCTD and SOP generation for whole electronic process.

Knowledge of eCTD filing and helping the group in the e-submission.

Monitor change control proposal to eliminate non-compliance risks.

Follow up with FDA for guidance, for queries related to dossiers or any updates on the filed submissions.

Other activities involve filing of Controlled correspondences and Bio correspondence, Suitability Petitions with USFDA.

Basic knowledge of European Guidelines\Regulations.

PROFESSIONAL QUALIFICATIONS

Master of Pharmacy in Pharmaceutical Chemistry from Hamdard University securing first division (2002-2004)

Qualified GATE –2002 (Graduate Aptitude test in Engineering) conducted by Indian Institute of Science, Bangalore with a percentile score of 98.76.

Bachelor of Pharmacy from Hamdard University securing first division (1998-2002)

EDUCATIONAL QUALIFICATIONS

12th from Kendriya Vidhalaya, Sainik Vihar securing first division (CBSE)

10th from Kendriya Vidhalaya, Sainik Vihar securing first division (CBSE)

RESERCH PROJECT UNDERTAKEN DURING M.PHARMACY

Synthesis and biological screenings of some new derivatives of Thiosemicarbazones

AWARDS AND ACHIEVEMENTS

Awarded Junior Research Fellowship by AICTE

All India Rank of 53 in the GATE exam conducted by Indian Institute of Science, Bangalore in 2002.

Done documentum training.

Done eCTD training and validation.

Attended training on ‘eCTDXpress’ organized by Image Solutions Inc.

Attended GPhA 2008 Fall Technical Conference at Maryland, USA.

Attended Conference on Transdermal and Topical delivery of Dermaceutical Cosmeceutical Products at Mumbai, India.

Awarded ‘Employee of the Quarter’ title for April-June 2009 by Ranbaxy.

Awarded with ‘Certificate of Appreciation’ for the year 2007 and 2008 by Ranbaxy.

Attended ‘Global Regulatory Meet 2010’ at Ranbaxy Laboratories Ltd., Gurgaon, India.

Attended ‘Global Pharma Regulatory Summit 2012’ at Mumbai, India.

ACCREDITATION AND LICENCSES

Registered Pharmacist with Delhi Pharmacy council

COMPUTER SKILLS

MS-Office applications

PERSONAL DETAILS

Father’s Name : Sh. D.P. Verma

Date of Birth : 18-09-1980

Marital Status : Married

Nationality : Indian

REFERENCES

Will be provided on request

Date:

Place: MANOJ KUMAR VERMA

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