NAVEEN KUMAR THOTA

Gig House, Bury Farm

Dickens Lane, Tilsworth, LU7 9PX.

Ph; 075********

Email: acdx06@r.postjobfree.com

OBJECTIVE

To secure a position in a well established organization that will lead to a

lasting relationship in the field of Regulatory Affairs.

PROFESSIONAL EXPERIENCE

July 2013 to till date: Presently working as Regulatory affairs associate

in Mundipharma Research Ltd, Cambridge

Responsibilities

. Maintaining regulatory information database EDMS (Electronic Data

Management System) of licenses, labeling and CMC data.

. Works closely with regulatory colleagues across sites, countries and

areas to ensure consistent approaches to Health Authorities.

. Co-ordinating with Authorities (EU & UK-MHRA) with respect to tracking

of Initial Dossier submissions, Variations and any other RFI queries.

. Working with cross functional teams (R&D, Manufacturing, QA, QC and

Packaging departments) in relation to questions from Authorities for

Product approvals.

. Procuring necessary data for compiling Module 3 of CTD from

formulation development and Analytical department.

. Experience in maintaining Regulatory files.

. Performing GAP analysis in the projects.

. Formatting the documents (Scanning, bookmarking, compilation &

rendering).

. Submitting Publishing request forms (ISI Publisher).

. Assigning Dossier IDs and creating Submission IDs.

. Creating empty submission VDOCs and compiling documents for submission

into VDMs.

. Uploading the documents into MIDAS.

. Creating and updating Envelopes, Templates.

. Document management (Files transfer, tracking & storage).

. Creating and updating Delta records.

. Importing the questions into CMC tracker from various authorities (EU

& UK-MHRA), i.e. creating RtQ Response documents.

. Naming the documents in line with CTD naming convention and make

documents submission ready.

June 2012 to July 2013: Worked as Regulatory affairs associate in Bristol

laboratories Ltd. (Luton, UK).

Responsibilities

. Co-ordinating with Authorities (EU & UK-MHRA) with respect

to Initial Dossier submissions, Variations and any other RFI queries.

. Providing technical support to internal stakeholder (QC,

R&D, QA, Manufacturing and Packaging departments).

. Coordinating with regulatory affairs and formulation

development departments for the preparation of reports and justification to

the queries related to manufacturing process, in-process specifications

and finished product specifications on both new dossiers and marketed

products received from Regulatory agencies.

. Maintaining internal database.

. Assisting in technology transfer activity by providing

information on the dossiers to contract manufacturing sites.

. Procuring necessary data for compiling Module 3 of CTD from

formulation development and Analytical department.

. Review of documentation like Product Development Reports, Batch

Manufacturing Records, Sampling protocol, Validation protocol,

April 2011 to May 2012

Formulation scientist, Bristol laboratories Ltd. (Luton, UK).

Responsibilities

. Formulation Development of generic drug products

especially oral solid dosage forms.

. Literature search and review.

. Designing and performing Preformulation studies and lab scale

experiments for developing product.

. Preparation of Product development reports, Batch Manufacturing

Records, Validation protocol.

. Interpretation of analytical results.

. Scaling-Up and Optimization of Manufacturing Process in

Transferring technology in GMP environment

. Trouble shooting

SKILLS

. Proficient in use of computer systems particularly Microsoft

office tools and Adobe Acrobat.

. Good organization, communication skills and working individually.

. Participating in internal team meeting and workshops.

. Fluent about Information retrieval from Internet and

database searching.

. Hands on usage of reviewing literature and documentation.

. Project completion in time & Management skills.

. Communicating with internal departments like analytical,

manufacturing and formulation development and externally with contract

manufacturers.

. Knowledge on Summary of Product Characteristics (SmPC),

Patient Information Leaflet (PIL) gained during the literature search

involved in Product development

. Familiar in handling all the Lab and Pilot machinery and

equipment in pharmaceutical manufacturing and formulation development.

. Expertise on Transfer of technology and for contract research

project with clients from European Union at their approved EU manufacturing

site.

ACADEMIC HISTORY

Nov-2005 to Jul-2007: Msc. Pharmaceutical Sciences, University of

Greenwich, Chatham, Kent, UK

Nov-1999 to Nov-2004: Bachelor of Pharmacy, Rajiv Gandhi University of

Health Sciences, Karnataka, India.

References

Available upon request

Contact this candidate