Assistant Manager

Job Description
Designation: Assistant Manager
Business Unit: Research & Development
Function: Global Regulatory Affairs
Office Location: Mahape, Navi Mumbai
Position description: To ensure regulatory submissions in various geographical areas like EU and Canada.
Primary Responsibilities
To meet the pre-requisites of respective Health Agencies and perform pre-submission due diligence where required (eg. EU/Canada where dossier extension from US approved portfolio is done).
Participation and provision of regulatory inputs in developmental activities at initial stages of product development.
To co-ordinate with various stakeholders for data requirements for review and dossier compilation in EU and Canada in accordance with updated regulatory guidance for the respective markets.
Compilation, review and submission of marketing authorization (MA) application to Europe market and abbreviated new drug submission (ANDS) to Health Canada ensuring they are in conformance with applicable regulatory guidelines and that the highest quality of standards are met.
Review and submit responses to queries (RTQ), clarifax (NON) received from the regulatory authorities within stipulated timelines
Support to business for Consolidated Pre-approved dossiers and timely response to deficiencies for Out Licensing Partners for EU market.
Tracking of Canadian Deficiency trends in order to establish a proactive approach during dossier filing.
Database maintenance for easy traceability of activities performed.
Educational Qualifications Preferred
M. Pharmacy (Pharmaceutics) ; Regulatory Certification.
Required Work Experience
9 – 12 years in Regulatory Affairs (EU, US/ CA Markets)
Experience in dossier submission of drug products for regulated markets.
Required Knowledge & Skills
Functional / Technical
Expertise in technical review of submission documents and compilation of dossier as per Agency’s expectation, which will lead to minimize queries from health agency.
Time management abilities, working well under pressure, self-motivated, strong work ethic, Flexibility/adaptability
Behavioural Attributes
Team work, positive approach in work, time management
Ability to work independently

Work arrangement
No