Shivraj Rajebhosale

FAQ About Shivraj Rajebhosale

• What is Shivraj Rajebhosale's address?

  Shivraj Rajebhosale is located at
  Mumbai, Mumbai, India

• What is Shivraj Rajebhosale's job title?

  Shivraj Rajebhosale is a
  Regulatory affairs professional with 5.5 years of experience. Professional Experience: o Compiling of the Annual Report and ensuring it is submitted prior to the commitment date (at minimum no later than the due date). o Compilation and submission of post approval supplements (CBE 0, CBE 30, PAS) in US. o Coordinating the retrieval of supporting documentation in accordance with the Annual Report schedule. o Retaining all supporting documentation as required in completing an Annual Report. o Notifying Regulatory Affairs Manager or designee (and Quality, if required) that an Annual Report is at risk of being submitted late. o Responsible for executing GRO RIMS operations in line with Work Instructions and SOPs. o Primarily responsible for RIM Central Data Service related product registration data management which includes the procurement of data from source regulatory documentation o Perform Quality Control (QC) and data integrity checking, as part of the RIM Central Data Services operation, to confirm the accuracy and completeness. o Develop labeling documents to ensure alignment with the Reference Listing Drug. o Work within the team to proofread established labeling files for content accuracy either manually or by utilizing the electronic proofreading tool. o Work with US Regulatory Labeling Team to ensure assigned projects like RLD updates, Safety labeling changes, Annual reportable changes, Electronic Medication Guide initiatives etc. and any other projects, as per requirement, are submitted on-time following the eCTD requirements related to labeling. o Maintain an accurate and current team tracker in order to identify and monitor all labeling projects ensuring timelines are met. o Provide regular project status check-ins, progress tracking, and updates on deliverables with internal team members, as applicable. o Maintain knowledge of US regulations, guidelines, and standard operating procedures applicable to US Gx labeling. o Responsibilities for cross-functional coordination (With Medical Affairs, Local Clinical Operations Team, Public Affairs, Supply chain management, PV, QA, Business stakeholders, external vendors/ suppliers/ partners) for regulatory support/ assistance. o Review and update of all labeling component as per reference listed drug along with confirming concern related patent and exclusivity. o Assessment and distribution of the safety variations and SERM reports. o Ensure timely submission/review of various compliance activities related commercial products (Regulatory life cycle management). Teva Pharmaceuticals

• What industry does Shivraj Rajebhosale currently work in?

  Shivraj Rajebhosale currently works in the
  Teva Pharmaceuticals

• What is Shivraj Rajebhosale's area of expertise?

  Shivraj Rajebhosale specializes in
  Regulatory affairs professional with 5.5 years of experience. Professional Experience: o Compiling of the Annual Report and ensuring it is submitted prior to the commitment date (at minimum no later than the due date). o Compilation and submission of post approval supplements (CBE 0, CBE 30, PAS) in US. o Coordinating the retrieval of supporting documentation in accordance with the Annual Report schedule. o Retaining all supporting documentation as required in completing an Annual Report. o Notifying Regulatory Affairs Manager or designee (and Quality, if required) that an Annual Report is at risk of being submitted late. o Responsible for executing GRO RIMS operations in line with Work Instructions and SOPs. o Primarily responsible for RIM Central Data Service related product registration data management which includes the procurement of data from source regulatory documentation o Perform Quality Control (QC) and data integrity checking, as part of the RIM Central Data Services operation, to confirm the accuracy and completeness. o Develop labeling documents to ensure alignment with the Reference Listing Drug. o Work within the team to proofread established labeling files for content accuracy either manually or by utilizing the electronic proofreading tool. o Work with US Regulatory Labeling Team to ensure assigned projects like RLD updates, Safety labeling changes, Annual reportable changes, Electronic Medication Guide initiatives etc. and any other projects, as per requirement, are submitted on-time following the eCTD requirements related to labeling. o Maintain an accurate and current team tracker in order to identify and monitor all labeling projects ensuring timelines are met. o Provide regular project status check-ins, progress tracking, and updates on deliverables with internal team members, as applicable. o Maintain knowledge of US regulations, guidelines, and standard operating procedures applicable to US Gx labeling. o Responsibilities for cross-functional coordination (With Medical Affairs, Local Clinical Operations Team, Public Affairs, Supply chain management, PV, QA, Business stakeholders, external vendors/ suppliers/ partners) for regulatory support/ assistance. o Review and update of all labeling component as per reference listed drug along with confirming concern related patent and exclusivity. o Assessment and distribution of the safety variations and SERM reports. o Ensure timely submission/review of various compliance activities related commercial products (Regulatory life cycle management).

• Which languages does Shivraj Rajebhosale speak? 

  Shivraj Rajebhosale speaks the following languages:
  No languages available.

• Which industries has Shivraj Rajebhosale previously worked in?   

  Shivraj Rajebhosale has prior experience in the following industries:
  Glenmark Pharmaceuticals , Merck

• What is Shivraj Rajebhosale’s work experience?  

  Shivraj Rajebhosale has the following professional experience:
  Teva Pharmaceuticals , Glenmark Pharmaceuticals , Merck .

• How can I find Shivraj Rajebhosale on LinkedIn?  

  You can view Shivraj Rajebhosale’s
  LinkedIn profile at LinkedIn URL.

• What are Shivraj Rajebhosale’s work email addresses?  

  Shivraj Rajebhosale’s work email addresses are
  [email protected].

• What company does Shivraj Rajebhosale work for?  

  Shivraj Rajebhosale works at
  Teva Pharmaceuticals