-Review of Drug Master Files, Registration Dossiers & Technical Data Packages/Open Parts for In-House developed APIs manufactured at In-House API manufacturing sites and contract manufacturing sites for adequacy and completeness prior to submission to regulatory agencies & customers respectively and ensuring their updations
-Review of Regulatory Amendments / Variations for smooth API supplies and responses to regulatory deficiencies for expeditious approval
-Provide Regulatory support to Chemical Research Division, Analytical Department, Chemical manufacturing, Quality Assurance, GMS and Regulatory Affairs-Pharma
Level of Responsibility: Medium
Scope: Global as DMFs/Registration dossiers are filed with various International regulatory Authorities (key countries are US, EU, Canada, Japan, Korea, China, Russia, Brazil, South Africa etc.)
-Successful filing of in-house developed APIs globally to support in-house & API customers ANDAs/MAAs
-Lifecycle management of APIs ensured by filing variations for post-approval changes
Delegation of Responsibility:
In the absence of job holder, responsibility will be delegated to a higher level or a colleague at same level.
-Review of Drug Master Files/Registration Dossiers, Technical Data Package/Open Parts of DMFs for In-House developed APIs for adequacy and completeness and ensure their updation to meet current regulatory requirements
-Facilitate life cycle management by ensuring timely filing of amendments/variations for post-approval changes including pharmacopoeial compliance for smooth API supplies
-Prepare and review responses to regulatory deficiencies
-Review of TDPs/Open Parts of outsourced APIs to support GMS and Regulatory Affairs-Pharma in connection with Drug products filings for Regulatory adequacy
-To provide regulatory support as well as to coordinate with Chemical Research Division, Analytical Department and Manufacturing locations in generating data as per the requirements of regulatory agencies
-To impart training to colleagues to keep them abreast with current Regulatory requirements/procedures
Assessment and Planning of Work
The work is assigned by Job supervisor based on filing priorities, business requirements and also based on self-planning. Based on work volume, work is further assigned to reportees and need to be supervised to get it completed on time with good quality.
-Interaction with Chemical Research Division, Analytical Department and Manufacturing locations to generate data as per current regulatory requirements in a timely manner
-To provide technical information to API customers for development of API Business
-To provide support to Regulatory Affairs-Pharma in their regulatory submissions to secure timely approvals
-To provide technical inputs to GMS for vendor selection and qualification of outsourced APIs/Key Intermediates for regulatory adequacy
The Technical competencies required are:
-Awareness about the current and evolving Regulatory Guidelines of various countries of interest to the Companys business.
-Effective oral and written communication to enable timely decision making, implementation and business understanding
-Strong knowledge of API process development.
-Strong knowledge of dossier compilation & filing as per country specific requirements
-To provide suggestions/recommendations to qualify changes.
-Improve the quality of work by providing accurate, timely and balanced views for the regulatory information desired by various business functions of interest.
-Provide inputs to develop the global regulatory pathways.
-Basic knowledge of IP rules and regulations in the region of operation
-Leadership and Interpersonal skills
-Problem solving attitude