Regulatory affairs

Mounika Dasari

Email: *****.******@*****.***

Ph: 312-***-****

Summary

Over 5+ years of experience in Regulatory Affairs with good knowledge in US FDA regulations, EU and ROW countries.

Effective independent worker as well as excellent coordinator with other members of a regulatory affairs team.

Prepared dossiers for various regulatory bodies such as EU and ROW countries based on CTD/ACTD format and as per the country specific requirements

Knowledge in ICH guidelines.

Compile and submit, regulatory documents in a timely manner according to regulatory requirements.

Knowledge of Drug Filing regulations, electronic submissions in eCTD format and via electronic submissions gateway (ESG), NDA and ANDA regulations, FDA guidance's, and USP requirements.

Compilation of Re-registration dossiers as per the respective country guidelines. To collect the complete set of documents by Coordinating with R&D, AR&D, QA/QC depts., and those documents are ensuring that error free and have minimum deficiencies for CTD & ACTD dossiers submissions.

Preparation and Review of Artwork for Respective semi-regulatory countries.

Assist in developing draft labeling for proposed and existing drug products.

Prepared applications for variations to regulatory agencies.

Maintained, scanned, and imported documents into regulatory documented system.

Well - versed with MS Office, Excel and adobe.

Aptitude to learn new ideas and quicker adaptation to the environment,

Commitment to success in achieving company goals, multidimensional view of a problem, good communication skills, willingness to learn, amicable team member.

Co-operation and co-ordination with interrelated departments, Strong decision-making, problem-solving abilities. Analyze problem, identify opportunities and formulate action plans.

Experience:

Abbott - Regulatory Operations Specialist - Contract Aug 2019– Till date

•Prepare, review and approves of technical regulatory documentation (DOC, IPMFAS and Labeling) in IRIS

•Assist with regulatory assessment of Change Impact Assessments in worldwide regulatory requirements.

•Prepare deliverables 1090 Fulfillment of Regulatory Strategy.

•Works on Local testing requirements for IVD’s and prepares IPAL monthly for Russia and India.

•Prepares Customer Release Testing (CRT) and validation files as per china requirements.

•Works in SharePoint and assists with various projects as needed.

•Participates in department and cross functional meetings.

AbbVie Inc- Regulatory Affairs Associate - Contract Mar 2018 – Aug 2019

Responsibilities:

•Assesses incoming global regulatory information (CTA, MAA, IND, Supplement’s, Amendments, Annual reports, PSUR etc) and enters data into the company systems.

•Worked in edocs, liquent insight documentum systems and SharePoint.

•Interacts with all areas of regulatory affairs and affiliates to ensure information is current, accurate and available in regulatory systems.

•Assist in development and implementation of process/system changes and/or data remediation projects.

•Troubleshoots errors and system performance and issues.

•Worked with supervisor and IT on business problem resolution and enhancements.

•Participated and contributed in group, department and cross-functional meetings.

•Provided input on training materials and assisted in training junior team members.

Maternity and Childcare break

July 2014 – Feb 2018

Aurobindo Pharma Limited - Regulatory Affairs Associate Feb 2010 - June 2014

Responsibilities:

Preparation of Dossiers, related queries and Variations for Semi – Regulated Markets viz. ASEAN, GCC, Eastern Europe, LATAM and EMEA Markets.

Compilation of Re-registration dossiers as per the respective country guidelines. To collect the complete set of documents by Coordinating with R&D, AR&D, QA/QC depts., and those documents are ensuring that error free and have minimum deficiencies for CTD & ACTD dossiers submissions.

Reviewing of Development documents for allocated projects. (DMF, MFC, Stability Protocol, AMV, FP & RM Specifications, STP’s.

Respond to Queries related to the complied dossiers.

Maintaining the different administrative documents like Certificate of Pharmaceutical product (COPP), Manufacturing License, Good Manufacturing Practice Certificate and Free Sale Certificate (FSC).

Organize and maintain Regulatory Affairs department files.

Assist in developing draft labeling for proposed and existing drug products.

Preparation and Review of Artwork for Respective semi-regulatory countries.

Review and final Approval of the Batch Processing Records, Validation protocols, and stability reports received from Quality Assurance.

Co-ordination with plant personnel for various Export orders and for required sample.

Co-ordination with Packaging department to develop and preparation of Master Packaging Document.

Provide Electronic Document Publishing support (i.e., scanning, rendering, bookmarking/hyperlinking and verification) and compiles Modules 1-5 in eCTD format, Paper or NeeS (where applicable).

Education:

Bachelor of Pharmacy, J N T U, India May 2009

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