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Position : Regulatory affairs ( API )
Location : Gurgaon
Accountabilities:
-Compilation of Drug Master Files, Registration Dossiers & Technical Data Packages/Open Parts for In-House developed APIs manufactured at In-House API manufacturing sites and ensuring their updation.
-Preparation of Regulatory Amendments / Variations for smooth API supplies and responses to regulatory deficiencies for expeditious approval
-Regulatory support to Chemical Research Division, Analytical Department, Chemical manufacturing, Quality Assurance, GMS and Regulatory Affairs-Pharma
-To ensure reposition of regulatory database and compliance to procedures
Level of Responsibility : Medium
Scope: Global (All International Regulatory Authorities/API customers)
Dimension:
-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.
Job Profile :
-Review of quality and manufacturing end data for various in-house developed APIs for regulatory adequacy for compilation of Drug Master Files/Registration Dossiers, Amendments/Variations, Technical Data Package/Open Parts of DMFs for In-House developed APIs and their updation to meet current regulatory requirements
-Review of outsourced APIs to support GMS and Regulatory Affairs-Pharma in connection with Drug products filings for Regulatory adequacy
-To coordinate with Chemical Research Division, Analytical Department and Manufacturing locations in generating data as per the requirements of regulatory agencies
-To ensure reposition of API dossiers into central repository and to provide information about regulatory commitments in timely manner
Assessment and Planning of Work
The work is assigned by job supervisor (Superior) based on filing priorities and business requirements
Key features:
-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 outsourced APIs/Key Intermediates for regulatory adequacy
Interface
Internal:
The position is required to interact with the following:-
-Analytical Research
-Chemical Research Division
-Regulatory Affairs-Pharma
-Manufacturing
-Quality Assurance
External:
The Position is required to provide support to the following:-
-Global Material Sourcing
-API Business
Competencies Required:
Technical Competencies:
The Technical competencies required are:
-Knowledge of dossier compilation skills as per country specific requirements
-Good oral and written communication skills
-Should have knowledge of current regulatory requirements of different countries
-Adequate knowledge of Microsoft office (MS-Word, MS-Power Point and MS-Excel) and Internet surfing
IF INTERESTED PLEASE SEND YOUR UPDATED RESUME TO [HIDDEN TEXT] / REACH ME AT 04033540809 / Whatsapp Number : 7386634920
Regulatory affairsRAAPIBulk drugsQuality assuranceQAActive pharmaceutical IngredientsCorporate Regulatory affairsSenior QASenior Quality assurance
2COMS has come a long way in a short time span of 6 years, expanding its business from Calcutta to other hubs and increasing its network ever since. At present, 2Coms has offices in Calcutta, Pune, Hyderabad, Siliguri, Guwhati, Jamshedpur and Bhubaneshwar propelled by a team of 60 trained consultants having the right combination of expertise and passion for achieving results making them deliver their best and achieving managerial excellence.
2COMS focuses on verticals like KPO / BPO / IT / Insurance, Banking and Finance / Telecom and Retail Pharma / Sales.
2COMS offers its clients end to end recruitment solutions tailor made to suit all kinds of manpower requirements.
Since its inception, 2COMS, with its domain expertise, enhanced business performance combined by focused insight and innovation, has gained a sound reputation amongst companies in businesses across all industries.
By Formulating effective strategies, we have gained a sound reputation of a premier staffing and recruiting Company, enabling us to attain the leading position in the industry. We are the preferred recruitment partners tomost of our clients. 2COMS efficiently services large-scale recruitment needs of its clients by its focused and integrated approach of flexibility, effective strategy, business expertise and powerful research capabilities.
2COMS has come a long way in a short time span of 6 years, expanding its business from Calcutta to other hubs and increasing its network ever since. At present, 2Coms has offices in Calcutta, Pune, Hyderabad, Siliguri, Guwhati, Jamshedpur and Bhubaneshwar propelled by a team of 60 trained consultants having the right combination of expertise and passion for achieving results making them deliver their best and achieving managerial excellence.
2COMS focuses on verticals like KPO / BPO / IT / Insurance, Banking and Finance / Telecom and Retail Pharma / Sales.
2COMS offers its clients end to end recruitment solutions tailor made to suit all kinds of manpower requirements.
Since its inception, 2COMS, with its domain expertise, enhanced business performance combined by focused insight and innovation, has gained a sound reputation amongst companies in businesses across all industries.
By Formulating effective strategies, we have gained a sound reputation of a premier staffing and recruiting Company, enabling us to attain the leading position in the industry. We are the preferred recruitment partners tomost of our clients. 2COMS efficiently services large-scale recruitment needs of its clients by its focused and integrated approach of flexibility, effective strategy, business expertise and powerful research capabilities.
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