ANITHA APPATHURAI

*/****, ********* **** ******

THORAIPAKKAM

CHENNAI

TAMILNADU

INDIA – 600 097 Phone: +91-950******* E-mail: adkdfe@r.postjobfree.com

EDUCATION

Bachelor of Engineering

Electrical and Electronics Engineering

1997-2001

University of Madras

First Class- 70%

LANGUAGES

English

Tamil

Hindi

STRENGTHS

Team Player

Leadership quality

LEAD MANAGERIAL SKILLS

Project Planning and coordination

Taking responsibility for personal development of team members.

Manage & co-ordinate New Project.

Resource Management.

Understanding key business drivers.

Analyzing and addressing issues by CAPA

Customer negotiation for new Project.

Lead experience for 20 members team.

Excellent written and verbal communication skills and Presentation skills

Excellent negotiation skills with representatives from other department of the organisation

Good working skills on MS Excel and PowerPoint

EXPERIENCE

Lead Regulatory Associate

Navitas Life Sciences, Chennai- India

April 2014- Present

Coordinating and submitting the various Regulatory submissions to Regulatory Authorities as per Regulatory requirements

Creating, updating, and maintaining labeling records throughout the life of a product

Submission of SPL to US FDA using ESG Gateway

Develop and update Regulatory SOPs

Compliant with customer SOP's and policies

Manage the day-to-day activities of direct reports, including project assignments and scheduling. Mentor and train junior staff and other members of the team and support the publication of high quality regulatory submissions to health and regulatory authorities worldwide

Coordinating day to day work with Teams located across the globe

Ensure all the assigned submissions are dispatched on-time.

Issue Analysis.

Provide guidance to direct reports and organize SME/PoC meetings with customer for latest updates.

To Identify the gaps in the ongoing projects and recommend a process improvements proactively internally and also with customers.

Ensure timeliness, quality and training of team members.

Preparation of monthly team performance metrics.

Utilization metrics review with the team for the existing projects on a weekly/monthly basis

Provide trainings for new joiners / refresher trainings for team members if required.

Senior Regulatory Associate

Take Solutions Global LLP, Chennai- India

April 2013- March 2014

Experience with various customers on Regulatory Submissions

oIND, NDA, ANDA, BLA submissions to US region

oEU(MRP, DCP, CP) submissions to Europe region

oGCC region submissions.

oAPAC and AU/NZ region submissions

oLATAM region submissions

Playing the role of Business Analyst in providing inputs to the Development Team (Pharma Ready Tool) on the Regulatory requirements of the customers and Regulatory agencies and helping them in testing (User Acceptance Testing) the product.

Playing the role of SME (Subject Matter Expert).

Experience on submitting Labeling (SPL) to FDA.

Regulatory Associate

Take Solutions Global LLP, Chennai- India

April 2010- March 2013

Hands on experience with various customers on Regulatory Submissions, IND, NDA, ANDA submissions to US region, EU(MRP, DCP, CP) submissions to Europe regions, GCC region submissions, AFME and LATAM region submissions and APAC region submissions

Establishment Registration of Manufacturing sites with FDA

NDC Labeler Code Registration with FDA

Technical Associate- Trainee

Take Solutions, Chennai- India

Sep 2008- March 2010

Creating the SPL using the Pharma Ready Tool and delivering to the customer

Creating the eCTD submissions and delivering to the customer

Contact this candidate