Mallikaarjunan R Email & Phone Number

India

• Responsibility of delivery of a top 5 Pharma client and several SMBs. Managing cross location teams of Chennai, Bengaluru, and Colombia, Bogota. >150 people overall and growing• Accountable for the managing delivery of service for the Regulatory services projects (Dossier Management, Publishing, CMC authoring, Labeling and Artwork etc.) as per the defined process and SLA. https://www.navitaslifesciences.com/• Responsible for realization of revenue targets • Responsible for profitability and other key service delivery related metrics• Execute plans and processes for improving service delivery and customer satisfaction• Support responding RFIs/ RFPs as required• Ensure that engagement is executed within agreed upon productivity and utilization metrics• Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables according to the requirements and standard operating procedures• Work closely with SMEs and QA to improve and exceed quality standards, identify process improvements, and ensure necessary training and skills• Implement transition plan for new process engagements to establish delivery of service

Chennai, Tamil Nadu, India

Chennai Area, India

Hyderabad Area, India

Hyderabad, Andhra Pradesh

Bengaluru Area, India

• Preparation and publication of electronic submissions, NeES and paper submissions• Support and conduct cross functional training on submission standards, procedures, and systems as required• Support compliance with worldwide submission regulations and guidelines• Supervise, mentor and train Regulatory Operations staff

Chennai Area, India

• Partnered with LIQUENT Inc for electronic Submission Services• Partnered with NOVARTIS for electronic Submission Publishing Services• At present I am in Novartis - Hyderabad, Involved in compiling electronic submissions using Liquent Insight Publishing Tool• Leading the Team in TAKE, responsible for Training in Work Flow Process, eCTD Product Development, Testing • Business Analyst role in eCTD - updating Business Requirement, Functional Specification, Test case review, conducting knowledge sharing sessions

• Trained on Virtify Regulatory Solutions Application at USA – Boston, MA• Conducting Knowledge Sharing Sessions on SPL/PLR and eCTD• Helping Sales and Marketing Team in Demand Generation Calls

• Understand and interprets U.S. Regulatory requirements; provides guidance on requirements to product development teams• Interpret xml specification for regulatory submissions (SPL/PLR, eCTD, PIM)• Involved Labeling in SPL/PLR (US) Conversion • Prepares U.S. regulatory submissions necessary for new product market Approval (ANDA)• Coordinates the preparation of additional data/information requested by regulatory agencies and prepares appropriate responses to all such requests.• Review labels, labeling, and promotional materials for compliance with applicable regulations and policies

Mba, Systems

B.Sc., Biotechnology