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Diks*********
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India
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Last Update: 14.05.2019 at 05:45
Job Type
Permanent
Start
May , 2019
Duration
5 Month
Place
Ahmedabad, IN
Country
India
Category
Regulatory, Quality and Clinical
Description
Competences Experience in handling African countries and other Asian/Latin region. Regulatory knowledge in handling pharmaceutical products as well as medical devices. Experience of handling eCTD/e-submission Experience in QA/QC functions and regulatory compliance. Updated on GXP concepts and various regulatory guidelines on WHO, EU and ICH. Should be energetic and passionate about work. Ability to maintain positive attitude when under pressure and in stressful situations. Good administrative skills. Experience in project management. Good communication skills. Should able to guide and lead the team. Should be well structured and systematic. Languages Proficiency in English and French Main Duties / Responsibilities Lead the development and execution of the long-term regulatory strategy for existing and new product portfolio for Africa and other ROW market. Ensure all activities related to Regulatory Affairs (RA), documentation (DOC) and Product Layout complies with company SOPs and regulatory / customer requirements. Ensure product registrations are executed for pharmaceutical products and medical devices as per application guidelines. Ensure regulatory queries are responded with adequate response and evidences in timely manner. Ensure to make payments for registration costs. Coordinate with state agents and Country Managers on handling of regulator submission and update on country situations/guidelines. Visit countries to develop relationship with NDRA, understanding countries requirements and define new approaches on regulatory submission. Ensure product layouts (labels, leaflets, SPCs) are prepared in line with regulatory compliance, reviewed and approved for pharmaceutical products and medical devices. Ensure that required documents for tender/pre-qualification/product approval purpose are collected from suppliers, reviewed and approved. Optimize capacity and distribution of work within Regulatory, Layout and DOC team. Responsible for recruiting and leading the staff of RA, DOC and Layout Contribute to the development within Operational Management Group (OMG) Support Quality Assurance activities as required. Interested candidate may APPLY , so we can get back to you. Also you may send your updated cv on jobs@sarthee.com with following details : Current Company Current Designation Current CTC Expected CTC Current Location Native Location Regards Team Sarthee This job is provided by Shine.com Desired Skills and Experience "regulatory strategy", doc, ra Seniority Level Associate Industry Chemicals Oil & Energy Pharmaceuticals Employment Type Full-time Job Functions Legal