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