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..
• 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

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