Regulatory Affairs General Manager

Manoj Kumar Verma Current Address

E. mail: ad70gy@r.postjobfree.com House.No. 136, First Floor

Tel. : +91-987******* Sector-7, Gurgaon-122001

Permanent Address

WZ- 1247 Rani Bagh

Delhi- 110034

Regulatory affairs professional with 20 yrs of industrial experience in regulatory submissions for Global markets

CAREER OBJECTIVE

Aspiring for a senior level position 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.

WORK EXPERIENCE

Organization

Dosage Forms and Key Markets

Designation

Duration

Sun Pharmaceutical Industries Limited

Branded Drugs - Solid Oral Dosage Forms, Semi-Solids, Parenterals - Global {i.e USA, Canada, Europe, Japan, Australia, ROW countries (APAC, LATAM etc)}

Deputy General Manager

Nov. 2022 Onwards

Fresenius Kabi Oncology Limited

Solid Oral Dosage Forms, Parenterals - Global {i.e USA, Canada, Europe (including Eastern Europe, Middle East and Africa), Japan, ROW countries (APAC, LATAM etc)}

Associate Director

Jan. 2020 – Nov. 2022

Assistant Director

Jan. 2017 – Dec. 2019

Manager-II

Jan. 2014 -

Dec. 2016

Wockhardt Limited

Solid and Liquid Oral Dosage Forms - USA, Canada, ROW countries

Manager

Aug. 2013 - Jan. 2014

Sentiss Pharma Ltd. (Erstwhile Promed Exports Pvt. Ltd)

Sterile Solutions i.e Opthalmic, Otic, Inhalation solutions and Solid Oral Dosage Forms - Global (i.e USA, Canada, Europe, ROW countries)

Manager

Sep. 2011 - Jul. 2013

Bal Pharma Limited, New Delhi

Solid and Liquid Oral Dosage Forms - Global (i.e USA, Europe, ROW countries)

Manager

Apr. 2011- Sep 2011

Sun Pharmaceutical Industries Ltd.

(Erstwhile Ranbaxy Laboratories Limited)

Solid and Liquid Oral Dosage Forms – USA and Canada

Senior Research Scientist-II

Jan. 2010 - Mar. 2011

Senior Research Scientist-I

Jan. 2008 - Dec. 2009

Research Scientist

Aug. 2006 -Dec. 2007

Research Associate

Aug. 2004 -Aug. 2006

CURRENT JOB PROFILE AND KEY RESPONSIBILITIES

At Sun Pharma, I am handling the Branded Drug portfolio with following Key responsibilities:

Providing regulatory CMC support for development and regulatory approval of multiple innovative products for a wide variety of therapeutic areas and dosage forms.

Ensuring CMC information in all applications including IMPDs/INDs, pre-IND, investigator brochures, DSURs, Agency briefing documents are complete, well written and meet all relevant requirements.

Planning, Monitoring and review of New Submissions, variations in global markets; ensuring adequacy and accuracy before submission.

Working in collaboration with the Regulatory strategy leads and involved in CMC topics for any negotiations with regulatory agencies to resolve CMC issues

Effectively communicating the regulatory CMC strategy to Regulatory strategy leads and other internal/external stakeholders

Providing strategic regulatory guidance on the change controls to enable global implementation.

Providing regulatory guidance to internal/external stakeholders throughout the life cycle of the product including during research and developmental activities

Providing regulatory input to Senior Management Teams in meetings/discussions.

Assessing the impact of new regulations, guidance and informing the relevant stakeholders on the requirements to maintain compliance with regulatory operations activities.

Mentoring team members

JOB PROFILE AND KEY RESPONSIBILITIES (Generic drug portfolio in previous organizations)

Planning, Monitoring and review of dossiers of formulations; ensuring adequacy and accuracy before submission of dossiers. [505(b)(2) NDAs, 505(j) ANDAs with US-FDA, ANDS with TPD-Health Canada, MAA for EU and NDA for ROW market].

Interfacing directly with R&D, QA, marketing, project management and production teams to assure regulatory compliance.

Team management and mentoring activities.

Regulatory support during pre-development/development stages and post approval stage(s).

Ensuring maintenance of registration certificates and 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.

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 affairs meeting across the globe

Providing inputs in the vendor qualification for API procurement.

Providing guidance to plant for any kind of regulatory issues.

Ensuring regulatory life cycle management of the products. Finalizing and review of Amendments, Post Approval Supplements, Annual Reports with USFDA

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

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

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

INTERNATIONAL EXPOSURE

Total 5 months working experience at Ranbaxy Pharmaceutical Inc., USA office in 2007 and 2008

Attended regional regulatory affairs meetings which were organized by Fresenius Kabi:

Global Regulatory Affairs meeting in Barcelona, Spain in 2015

Global Regulatory Affairs meeting in Lisbon, Portugal in 2016

Latin America Regulatory affairs meeting in Buenos Aires, Argentina in 2016

Global Regulatory Affairs meeting in Rome, Italy in 2017

Asia Regulatory affairs meeting in Hong Kong in 2017

Latin America Regulatory affairs meeting in Valparaiso, Chile in 2018

Global Regulatory Affairs meeting in Prague, Czech Republic in 2018

Global Regulatory Affairs meeting in Dubrovnik, Croatia in 2019

Attended International Conferences on following:

PDA Workshop on Extractables and Leachables at Brussels, Belgium in 2014

GPhA 2008 Fall Technical Conference at Maryland, USA

AAM CMC workshop 2017 at Maryland, USA.

CRED Getting the CMC Dossier Right Organised by TOPRA at London, UK in 2018.

AUDIT EXPOSURE

USFDA and MHRA

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.

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.

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

Attended training on ‘Aseptic Filter Validation’at Merck, Bangalore, India

VISA

Valid US Business visa for 10 years upto 2027

SOFTWARE SKILLS

eCTD Manager/PharmaReady for regulatory submissions, ISI Toolbox, Adobe Acrobat, ESG, Lorenz Validator, Documentum, Trackwise, KIPDIPS (Score)

Proficient with Microsoft Word, Excel, PowerPoint, and Internet.

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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