Experience

Novartis Healthcare P Limited

• India
• Biotechnology Research
• 1 - 100 Employee

• Sr. Manager Regulatory Affairs - Global Drug Development India

  • Feb 2022 - Present



Roche Products (India) Pvt. Ltd.

• Mumbai, Maharashtra, India

• Regulatory Affairs Manager

  • Jan 2020 - Feb 2022



Bayer

• Chemical Manufacturing
• 700 & Above Employee

• Senior manger - Regulatory Affairs

  • Jun 2016 - Dec 2019

  - Working closely with commercial, medical, and RA stakeholders for regulatory activities including submissions & regulatory strategies. - Ensuring regulatory licenses to operate through full level of compliance by timely renewal & managing post-approval variations - Providing proactive regulatory partnership to commercial teams to support regional and country level business priorities. - Collaborating with local, regional & global stakeholders for regulatory activities & projects. - Lead and manage FDA and CDTL liaising. - Supporting local & global assessments for established products. - Collaborating with commercial and strategy team to identify new launch/extension opportunities. Show less



Eisai Inactive Page

• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Manager - Regulatory Affairs and Quality Assurance

  • Apr 2013 - May 2016

  - Planning and managing submissions for DCGI, India for in-licensing of Drug products and Medical devices in Indian market. - Delivering submissions for NDA/ Clinical trials, Registration certificate, Import license, Repacking permission and Test license. - Preparation of documents for Clinical trial application (CTA). - Managing Corporate Quality Assurance functions such as batch release, change controls, deviations, cGMP audits of CMO and suppliers and artworks approval. - Coordinating with CROs for planning of local clinical trials. Show less



FDC Limited

• Mumbai

• Executive- Regulatory Affairs

  • May 2012 - Apr 2013

  -Compilation of e-CTD submissions for US, Europe and Australia. -Managing submissions for new ANDAs and post approval changes submissions for US market. -Delivering submissions for MHRA,UK and EU-DCP products including variations for appropriate life cycle management of the products. -Providing inputs for continuous improvements of Quality documents. -Handling change controls. -Compilation of e-CTD submissions for US, Europe and Australia. -Managing submissions for new ANDAs and post approval changes submissions for US market. -Delivering submissions for MHRA,UK and EU-DCP products including variations for appropriate life cycle management of the products. -Providing inputs for continuous improvements of Quality documents. -Handling change controls.



Unimark Remedies Limited

• Mumbai Area, India

• Executive- Regulatory Affairs

  • Jun 2010 - May 2012

  - Planning and delivering regulatory submissions for DCGI, India and ROW market. - Full operational knowledge for regulatory approval procedures of DCGI, India. - Delivering ANDA submissions and handling tactical activities for ANDA formulation development. -Planning and managing regulatory activities for Semi Regulated markets. - Planning and delivering regulatory submissions for DCGI, India and ROW market. - Full operational knowledge for regulatory approval procedures of DCGI, India. - Delivering ANDA submissions and handling tactical activities for ANDA formulation development. -Planning and managing regulatory activities for Semi Regulated markets.



Themis Medicare--

• 1 - 100 Employee

• Officer-Scientific affairs

  • Jan 2009 - May 2010

  -Dual functions of regulatory affairs as well as project management for new product development and scale up. -patent status search for territories and drafting the patent applications for conventional and modified release dosage forms. -Dual functions of regulatory affairs as well as project management for new product development and scale up. -patent status search for territories and drafting the patent applications for conventional and modified release dosage forms.