Experience

Mac-Chem Products India Pvt. Ltd.

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Corporate Regulatory Affairs & Business Development - Assistant Manager

  • Dec 2021 - Present

  Looking after regulatory aspects and techno commercial matters for Eu, LATAM, Korea, China, SEA markets on business development perspective. Regulatory Affairs: • To prepare CMC registration packages to support new registrations, post approval changes, and renewals. • Responsible for preparation and review of technical regulatory documentation for agency submission, ensuring the accuracy and quality of documentation. • To prepare responses for deficiency letters received from Health authorities and clients/organization. • To assess and approve manufacturing change requests and update files accordingly as a part of product life cycle management. • Represent Regulatory Affairs as technical lead for client meetings in which Regulatory Affairs is of primary interest. • To provide input to regulatory submission as per strategic planning. • To participate & co-ordinate with cross functional teams that include representatives from different locations and to amplify & achieve the business goals. • To keep track on actual & planned project activities, timelines & identify and communicate issues to respective teams that impacting project progression. Business Development: • To identify DMF registration opportunities for in terms of SRA (Stringent Regulatory Authorities/areas) markets to enhance business growth. • Use existing contacts and networks to identify potential leads to build a pipeline of potential Regulatory Affairs clients. • To initiate and be active part of regularly scheduled calls across BD team, representing Regulatory Affairs. • Proactively identify technical client leads across targeted markets/segments directed by Business Development management. • Interact and support BD with engagement for potential and existing clients. • Act as an interface with client’s CMC Regulatory/BD team, ensuring continued interactions and sharing of client opportunities and prospects. • Responsible for regulatory management and expansion.


Tata Consultancy Services
• India
• IT Services and IT Consulting
• 700 & Above Employee
• Business Process Lead

  • Nov 2018 - Nov 2021


BEC Chemicals Pvt. Ltd.

• India
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Senior Regulatory Affairs Specialist

  • Jul 2015 - Oct 2018

  Regulatory Affairs: - CTD preparation and publication in Nees format - Submissions to EDQM via CESP - Filing of dossiers for Certificate of Suitability (EDQM) for APIs and subsequent revisions and renewals, notifications and pre-approval - Well versed for handling regulatory aspects for PMDA, Japan - Exposure of Japanese regulatory audit, Pharmaceutical and Medical Devices Agency (PMDA) and USFDA - Good knowledge of Good Manufacturing Practices (cGMP), ICH Guidelines - Handling technical queries received from Regulatory bodies like LATAM, PMDA, EDQM, etc. Corporate Quality Assurance: - Change control management with its timely implementation - Pre-approvals or notifications whichever requires from customer or regulatory agencies based upon the evaluated changes - Review of QMS documents - Reviewer of Standard Testing Procedures, process & method development and validations protocols and reports - Vendor Evaluation and development - Participation in Internal and external audits performed by organization Understanding of market strategies and tools for drug development