Job Description:
Dossier preparation, ensuring timely submission of dossiers, respond to queries from regulatory authorities and keeping one’s self updated with changes to the regulatory environment with the objective of ensuring that the organization obtains approvals and licenses in a timely manner.
Dossier preparation, ensuring timely submission of dossiers, respond to queries from regulatory authorities and keeping one’s self updated with changes to the regulatory environment with the objective of ensuring that the organization obtains approvals and licenses in a timely manner.
• Regulatory Plan Creation: Collaborate with global teams during early stages of product development; Understand regulatory requirements in the country from development and data perspective; Understand timelines of availability of various documents for filing the application and prepare the dossiers / application for quality submission on time
• Dossier preparation, review and submission: Request documents from global and local teams for filing the application well in advance; Co-ordinate with team members for accurate collation of the documents for filing the application; Proactively, work with the liaison person to track the submission; Understand likely queries and keep documents ready in advance to either share the same to prevent the query or to have short lead time in submitting the response
• Lifecycle Management: Prepare and maintain the trackers for market authorization, registration certificates, import licenses, post marketing commitment, package insert submission so as to facilitate timely submission of the applications as well as for maintaining regulatory compliance at high level; Plan renewal filing well in advance to avoid any delays in submission due to non-availability of the documents; Evaluate and submit variations in a timely manner
• Regulatory Environment updates: Keep a track on the development activities of competitors and communicate to the team members on real time basis.
• Dossier preparation, review and submission: Request documents from global and local teams for filing the application well in advance; Co-ordinate with team members for accurate collation of the documents for filing the application; Proactively, work with the liaison person to track the submission; Understand likely queries and keep documents ready in advance to either share the same to prevent the query or to have short lead time in submitting the response
• Lifecycle Management: Prepare and maintain the trackers for market authorization, registration certificates, import licenses, post marketing commitment, package insert submission so as to facilitate timely submission of the applications as well as for maintaining regulatory compliance at high level; Plan renewal filing well in advance to avoid any delays in submission due to non-availability of the documents; Evaluate and submit variations in a timely manner
• Regulatory Environment updates: Keep a track on the development activities of competitors and communicate to the team members on real time basis.
Functional Competencies:
• Roche high performance competencies Decision making
• Influencing /persuasion skills Driving collaboration and team work Technical knowledge
• Organization and planning skills Negotiating skills Communication Skills Presentation Skills
• Proven ability to interact well in a multifunctional team setting
• Accuracy and attention to detail
• Roche high performance competencies Decision making
• Influencing /persuasion skills Driving collaboration and team work Technical knowledge
• Organization and planning skills Negotiating skills Communication Skills Presentation Skills
• Proven ability to interact well in a multifunctional team setting
• Accuracy and attention to detail
Behavioral Competencies:
• Strategic Agility Achieving results
• Team work and Collaboration Inspiring and Influencing Interpersonal Skills Adaptability
• Patient centricity in decision making
• Feedback and coaching
• Strategic Agility Achieving results
• Team work and Collaboration Inspiring and Influencing Interpersonal Skills Adaptability
• Patient centricity in decision making
• Feedback and coaching
Additional Information
Location : Mumbai, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th March, 2019
Location : Mumbai, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th March, 2019
No comments:
Post a Comment