Senior Manager Regulatory Affairs
5 days ago
Job Title- Senior Manager-Regulatory Affairs Job Function-International Business
Key Responsibility:- Ensure all the regulatory activities after the product finalization in South America incl. selection of the consultants for registration in the local country. Ensure all the local registrations & compliances related to the registrations are being followed Ensure compliance with European Union (EU) regulatory requirements, including the Medical Device Regulation (MDR), Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Classification, Labelling and Packaging (CLP) Regulation, and Conformité Européenne (CE) Marking, for all exported products. Prepare, compile, and submit regulatory dossiers and technical documentation to support product registration and approvals within S.America, EU & ASIA member states. Strategically manage regulatory submissions in alignment with relevant related guidelines to ensure timely approvals and market entry. Establish and maintain effective communication channels with regulatory authorities, notified bodies, scientific experts, and key stakeholders to facilitate efficient registration processes and regulatory compliance. Provide regulatory input during product development and changes to existing products Good knowledge about the CIB and Indian regulatory environment Making the MIS and related reporting data to HOD & management Proficient in MS Office, specially Excel & Power point
Skills- Strong understanding of South America/EU/ASIA regulations, Familiarity with international standards. Education Qualification- MSc Ag/MBA Experience- 8 years of relevant experience
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Delhi, Delhi, India Self-employed Full timeCompany DescriptionFounded in the commercial operations year of 2015-16, NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
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Delhi, Delhi, India Self-employed Full timeCompany DescriptionFounded in the commercial operations year of 2015-16, NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
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Delhi, Delhi, India Self-employed Full timeCompany Description Founded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
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