Project Managment, eCTD Submission

ARIHANT PRADHAN

**** ******* ******, ***********, *** 3H7

Phone (M): +1-416-***-**** ***********@*****.**********

Highly effective management professional emphasizing innovation and creativity in solving complex problems.

Lead moderate to high complexity global regulatory submissions processes in both electronic submission (eCTD) and non-eCTD electronic submission (NeeS) format.

Energetic and results-focused with success in developing and leading diverse teams to achieve outstanding results.

Plans, coordinates, compiles, publishes and submits regulatory applications, in compliance with health authority regulations worldwide. Also responsible for ensuring documents are compliant with company standards, ICH, and other guidelines for incorporation into eCTD submissions using publishing and editing tools like PRISM/CARA, Lornez, View Point.

Efficiently manage team of publishers across the geographies & successfully delivered high quality projects within agreed timelines

High skills in Quality Assurance & Quality Control, GMP & Resource Management for electronic submission.

Manage multiple projects and prioritise to achieve business operatives for Regulatory Operations project.

Manage resource allocations job distribution, performance, evaluation of team members.

Responsible for setting up processes, leading process improvements initiatives and managing project delivery of Regulatory submission.

Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel), Adobe Acrobat plug-ins, relevant publishing and document management systems/software

SKILLS HIGHLIGHT

Excellent Communication and interpersonal skills

Critical thinker and problem solving skills

Time Management skills

Cross Functional project management

Team Leadership

Quick learner

Good judgment and decision making skills

Organizational and multitasking capabilities

CERTIFICATE

Regulatory Affairs in Pharmaceuticals – Regulatory Affairs Professional Society (RAPS)

WORK EXPERIENCE (2008-2018)

Asst. Operation Manager - Regulatory Operations 2013 - 2018

Accenture

Plan, coordinate, compile and file drug product submissions for regulated market for a variety of dosage forms in eCTD format and validate the sequence for the successful registration of drug product for international markets.

Prepared submissions in eCTD format which involves full understanding of the use of Adobe Acrobat and plug-ins to create bookmarks and links.

Expertise & hands on experience for NDS, ANDS, Pre-IND, IND, ANDA, MAA, Post Approvals (Lifecycle Management), Clinical & Nonclinical documents, Protocol, IB, EOP, Briefing Documents, DSUR OPDP, Safety and CSR, submission etc

Worked on CMC Baseline management.

Conducted issue resolution, communicated with clients and their functional areas to ensure issues are resolved in a compliant manner.

Lead trainer responsible for active coaching, mentoring & training of project teams, regulatory team, external consultants for eCTD publishing tools, Word templates, eCTD specifications etc.

Led the preparation of Process and Project Documents (Business Guidance/policies, SOP’s & Process Maps, Publishing Standards & Module 5 Publishing Standards), Submission Publishing, Submission Template Preparation, Submission Template management & Testing

Created a working model for EMEA Policy 70 project which resulted in cost saving.

Pro-actively shared best practices within the department and cross-functionally. Identified and communicated opportunities for departmental enhancements and efficiencies.

Senior Executive- Regulatory Affairs 2012 - 2013

ELC Group

Responsible for Compilation of module 1 for EMEA Submission.

Prepared and reviewed SMPC.

Calculated Fees Structured for EMEA Submission.

Prepared and reviewed the Query and Responses.

Handled submission of product registration and reviewing of module 2 to 5.

Prepared dossier as per eCTD and NeeS for submission.

Managed and developed various type of variation such as RMP, SMPC and Application Fees.

Executive - Regulatory Affairs 2011 – 2012

Orchid Healthcare

Handled compilation of Annual Report and ANDA for US Market.

Managed, reviewed and labeled data for ANDA compilation.

Prepared responses for FDA CMC (Chemistry Manufacturing & Control) deficiency letters.

Maintained Post ANDA Submission and Post Approval Activity i.e. Query Response, Amendment and Supplement Filing.

Analyzed PDR, MPR, MFR, Validation Documents, PM/RM/IP/FP and method of batch records as per current FDA requirements.

Coordinated with various department for collection of documents, before the formulation of the dossier and time to time follow up.

Assisted in audit of FDA, pre-approval and GMP inspections.

Executive - Regulatory Affairs 2010 – 2011

Alpa Laboratories Limited

Prepared & submitted dossier for drug product approval as ASEAN Common Technical Dossier (ACTD) and Rest of the world.

Managed drug product life cycle for non-regulated countries in accordance to their regulatory guidelines and received approvals.

Reviewed technical documents and dossier.

Officer - Quality Assurance 2008 – 2009

Cyano Pharma Private Limited

Handled all operations in Production/QC Stores with relevant cGMP guidelines.

Supported WRC / external audit personnel in the inspections process.

Prepared corrective action plan in conjunction with Production / QC / Stores.

Issued & reviewed BMR/BPR with each page comprised of unique signature for authenticity and QC data for each product batch before final release of the product.

Responsible for change controls to regularized change in equipment, facility, utility, primary pack, analytical procedure etc.

Validated relevant QA in process checks and line clearances on daily basis.

Industrial Training

Ranbaxy Laboratories Limited

Responsible for documentation related to the manufacturing of the products.

Handled procedures for different products and various equipments used in formulation.

Undergone training to maintained packaging standards with the help of quality tests.

EDUCATION

Bachelor's of Pharmacy

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