Senior Regulatory Specialist
5 days ago
We're hiring Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon. Job Summary Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility 1. New submissions: a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy. 2. Approval : Review & prepare response to deficiency enabling approval of products filed to regulatory agency. 3. Lifecycle management for drug formulations: a. Prepare and review variation , Annual notification and labelling approval for US and OAM b. Review of change control and file variation as per country requirement 4. Regulatory compliance: a. eCTD compilation b. Ensure reposition of comprehensive product information into central repository C. Review regulatory filing impact of variations, change controls, etc.
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Senior Regulatory Specialist
3 days ago
Gurugram, India SUN PHARMA Full timeWe're hiring!! Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon. Job Summary Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility 1. New submissions: a. Review & prepare CMC...
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Senior Regulatory Specialist
5 days ago
Gurugram, India SUN PHARMA Full timeWe're hiring!! Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon. Job Summary Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility 1. New submissions: a. Review & prepare CMC...
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Senior Regulatory Specialist
5 days ago
Gurugram, India SUN PHARMA Full timeWe're hiring!! Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon. Job SummaryRegulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.Area Of Responsibility 1. New submissions:a. Review & prepare CMC...
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Senior Regulatory Specialist
5 days ago
Gurugram, India SUN PHARMA Full timeWe're hiring!! Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon. Job SummaryRegulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.Area Of Responsibility 1. New submissions:a. Review & prepare CMC...
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Senior Regulatory Specialist
5 days ago
Gurugram, India SUN PHARMA Full timeWe're hiring!! Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon. Job SummaryRegulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.Area Of Responsibility 1. New submissions:a. Review & prepare CMC...
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▷ [Urgent] Regulatory Affairs Specialist
3 weeks ago
Gurugram, India Respironics Inc Full timeJob Description Job Title Regulatory Affairs Specialist Job Description Job title: Regulatory Affairs Specialist Your role: Regulatory Affairs Specialist - ISC will have an exciting opportunity to work with the ISC Commercial Regulatory Affairs Team and help business with product registration in the India Sub Continent, actively providing value-added...
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Senior Regulatory Affairs
2 weeks ago
Bengaluru, Gurugram, India Saraca Solutions Full time ₹ 6,00,000 - ₹ 12,00,000 per yearPlanning, organizing and implementing strategies and activities required to procure regulatoryapproval for new and revised product lines under the guidance of more senior regulatoryprofessionals. Required Candidate profile5-10(k) and CE Marking; IDE, PMA (original/revision/supplements) preparation a plusMinimum 1-year experience in FDA regulated...
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Senior Design Specialist
2 days ago
gurugram, India beBeeDesign Full timeSenior Design Specialist Job DescriptionWe are seeking an experienced Senior Design Specialist to oversee architectural and interior designing projects. The ideal candidate will be responsible for project planning, coordination, material procurement, and implementation of projects.Develop and execute project plans, ensuring timely completion and quality...
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Regulatory Reporting Senior Analyst
4 weeks ago
Gurugram, India Fidelity International Full timeJob Description About the Opportunity Job Type: Permanent Application Deadline: 08 November 2025 Title Senior Analyst, Global Regulatory Reporting Department Global Regulatory Reporting Location Gurgaon Reports To Global Regulatory Reporting Senior Manager Level Senior Analyst We're proud to have been helping our clients build better financial futures for...
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Regulatory Advisory Manager
5 days ago
Gurugram, India MSKA & Associates Full timeAbout the Ethics & Independence Function:The Ethics & Independence (E&I) team plays a pivotal role in safeguarding the firm’s reputation and regulatory compliance by proactively managing internal risks related to client acceptance, engagement continuance, and conflict of interest assessments. The team ensures the firm’s adherence to internal policies and...