Experience

Somerset Therapeutics Limited

• India
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Head Regulatory Affairs (GM)

  • Jul 2013 - Present

  Head Regulatory Affairs (GM), responsible for planning, execution and submission of ANDAs manufactured for Somerset Therapeutics, LLC - US. -Attend, Management review meetings and to set regulatory filing strategies for US Market. -Facilitate and organize the compilation of Applications (ANDA) to FDA, Center for Drug Evaluation and Research in support of Generic products. -Act as liaison with all departments for preparation of documentation necessary for submission of applications. -Review data from contributing departments and provide comments to assure accurate and complete documents for inclusion in ANDA applications. -Supervise and coordinate the planning of FDA submissions for assigned products/projects to ensure most efficient use of resources. -Review, compilation and submission of ANDAs as per the FDA check list. -Review, compilation and submission of Annual reports and post approval changes such as CBE 0, CBE 30 and PAS (Prior Approval supplements). -Review, compilation and submission of Quarter and Annual PADERs (Periodic Adverse Drug Experience Reports) as applicable. -Coordinate the preparation of responses to regulatory agency as applicable. -Review and approve specific change controls as they relate to regulatory submissions and provide the necessary documents in implementing the changes. -Control all Pharmaceutical Master Labeling, master label approvals and to maintain a labeling change control process. -Train the team with respect to CMC topics. -Preparation of controlled correspondences for Q1-Q2. Show less



Panacea Biotec

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Asst. Manager - Regulatory Affairs

  • Feb 2010 - Jul 2013

  * Preparation, Submission & Review of Dossiers for ROW Countries (African, CIS, ASEAN & LATAM) -To collect the guidelines of respective countries for preparation and updation of the checklists. -To collect the dossier schedule from Int. Marketing and to evaluate the products for feasibility of filing in ROW countries. -To co-ordinate with departments like R&D, CRD, QA, QC, MM etc. for data generation as per countries requirement and provision of other technical documents. -To review the technical documents and preparation of dossiers as per the committed timelines and interaction with the respective country Distributor/agent for effective filing and faster registration. -To generate additional documentation as per the country specific requirement through coordination with R&D & QA. -To prepare and submit applications to DCA for COPP, FSC etc. & DCGI for licensing of new products etc. -To respond the queries received from various regulatory agencies. -To coordinate with supporting departments for cGMP inspections from concerned MOH. -To plan and coordinate with other departments for registration of the company in respective MOH wherever applicable. -To review common artworks as per common labeling requirements. To review and approve the artworks of respective countries as per country specific labeling requirements for commercial supplies. -To coordinate with QA for registration samples. -To share the RPI i.e., Registered Product information of the products with concerned departments to follow during commercial supplies. -Maintenance of registration and under registration status of products. -To file Re-registration dossiers as per country specific requirement and to file variations like site change, pack size, updated formula etc. -To review dossiers of Team members. -To evaluate and approve the change controls. Show less



Aurobindo Pharma

• Hyderabad Area, India

• Sr. Executive - QA, Regulatory Compliance

  • Jun 2005 - Jan 2010

  -CMC Documentation review & preparation of documents for Regulated & Non-regulated Markets). -Ensuring compliances of the exhibit batches (pre and post) with respect to regulatory requirements and generation of additional documentation required for filing across various countries. -Ensuring compliance of the export batches (US, EU, etc) and providing release certificate as per the defined SOP’s. -To review Batch records (Manufacturing & Packaging). -To Review Analytical documents, Process validation, Stability protocols & reports -To provide query response received from various markets. -To review artworks as per common labeling requirements. -To provide finished product samples and their respective reference standards to various markets as per the country’s requirement. -Change control & Deviations coordination and management. -Actively involved in Regulatory (USFDA, NAM, ANVISA…….etc.) and Customer audits. Show less



Qualicare Pharmaceuticals Ltd (Manufacturer of Tablets, Capsules, Dry powders)

• Hyderabad Area, India

• Production Executive

  • Jan 2004 - Mar 2005

  - Manufacturing, Packaging (Tablets & Capsules) and completion of their records. - Manufacturing, Packaging (External & Oral powders) and completion of their records. - Documentation & Dispensing of Raw materials / Packing materials. - Manufacturing, Packaging (Tablets & Capsules) and completion of their records. - Manufacturing, Packaging (External & Oral powders) and completion of their records. - Documentation & Dispensing of Raw materials / Packing materials.