Regulatory affairs specialist
10 hours ago
Role - Formulation Regulatory Affairs - for Peptide products or InjectablesLevel - Deputy Manager/ Associate ManagerRequired Education/Exp:Experience Req.: 8 - 12 yrs.Qualification: - M. Pharma / M. Sc.Key Role- Formulation Regulatory Affairs for Peptide products or InjectablesResponsibilities:- Drafting controlled correspondences, pre-development meetings and scientific advices for seeking regulatory feedback on various topics from different Health-Agencies especially for peptides products & Injectables.- Prepare a regulatory submission strategy, checklist for administrative and technical documents for each submission considering country specific requirements for peptide products.- Compilation of CTD sections and supporting documents from Module 1 to 5 with respect to each Health-Agencies and ensure the regulatory compliance to most current requirements.- Prepare a draft response to queries raised by the Health agencies / Business partner with supporting updated documents. Ensure to respond within the prescribed timelines.- Review and provide Technical inputs during product life cycle starting from developmental documents, drug-device combination product and clinical/non-clinical proposals.- Co-ordinate with all cross-functional teams and regularly updating the status tracker/checklists and keep updating reporting head.- Any other responsibilities vested by reporting head based on requirements.Required skills :-- Hands on expertise of handling Peptide or Injectable products.- Peptide Regulatory Exp will be prefered more.- Well versed with regulatory guidelines.Candidates with relevant exp., kindly share CVs to apply on :- Kindly mention below details while sharing CV :-- Total Exp?- Current CTC?- Handling exp of Peptide Regulatory or not?- Notice Period?- Ready to work in Bangalore (onsite) ? (5 Days working)
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Regulatory Affairs Specialist
4 days ago
Bengaluru, Karnataka, India Biocon Biologics Full time ₹ 9,00,000 - ₹ 12,00,000 per yearPosition SummaryThe Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in...
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Regulatory Affairs Lead Specialist
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IND--Bengaluru-Kalyani Platina, Magnolia, India GE Healthcare Private Limited Full time ₹ 20,00,000 - ₹ 25,00,000 per yearLead Specialist, Regulatory Affairs Job Description SummaryIn this role you will be focused on obtaining and maintaining global third-party supplier documentation for Imaging Accessories& Supplies (A&S) products. Under the instruction from A&S Product RA ensuring documentation requirements are obtained in accordance with the supplier contract for initial...
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Regulatory Affairs Manager
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Bengaluru, Karnataka, India Kumar Organic Products Full timeJob Title: Regulatory Affairs ManagerDepartment: Regulatory Affairs / Quality & ComplianceReporting to: Head Regulatory AffairsJob Purpose:To lead and oversee all regulatory affairs activities, ensuring company products comply with applicable local and international regulatory requirements. The role involves developing regulatory strategies, managing...
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Manager - Regulatory Affairs
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Bengaluru, India Aarna Hr Solutions Full timeJob Description We are seeking a highly experienced and meticulous Manager - Regulatory Affairs to oversee and execute all regulatory activities for drug substances and products. The ideal candidate will be responsible for the preparation, submission, and management of various regulatory documents, ensuring compliance with global regulatory agencies. This...
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Regulatory Affair Manager
2 days ago
Bengaluru, Karnataka, India Futura Surgicare Full time ₹ 20,00,000 - ₹ 25,00,000 per yearPosition Title: Regulatory Affairs & QA ManagerDepartment: Quality & Regulatory AffairsLocation: BangaloreRole OverviewThe Regulatory Affairs cum QA Manager will be responsible for ensuring compliance of medical devices with applicable international and local regulatory requirements, while also leading the Quality Management System (QMS) to meet ISO 13485,...
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Regulatory Affairs Executive
1 week ago
Bengaluru, Karnataka, India Kerala Ayurveda Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per yearAre you passionate about ensuring regulatory excellence in the world of Ayurveda and nutraceuticals?Kerala Ayurveda Limited is looking for a Regulatory Affairs Executive with 4-6 years of experience to join our growing team in Bangalore. This is a great opportunity to work at the intersection of traditional Ayurvedic wisdom and global compliance standards,...
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GE HealthCare
3 weeks ago
Bengaluru, India WIPRO GE HEALTHCARE PRIVATE LIMITED Full timeLead Specialist - Regulatory Affairs Location : Bangalore Experience : 8+ years- In this role you will be focused on obtaining and maintaining global third-party supplier documentation for Imaging Accessories & Supplies (A&S) products. - Under the instruction from A&S Product RA ensuring documentation requirements are obtained in accordance with the supplier...
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Senior Regulatory Affairs Specialist
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Bengaluru, India Classic Search Private Limited Full timeRole - Team Lead - International Regulatory Affairs Location - Bangalore Industry - Pharmaceutical Required Experience :- 10-15 yearsEducation :- M.Pharma / M.ScMust have experience in IRA handling regulated or unregulated region and submissions, handling a team of 2 for submissionWill lead a team of atleast 10 people(Team Leading exp is mandatory)Good...
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Regulatory Affairs Specialist
1 day ago
Bengaluru, India Biocon Full timeRole - Formulation Regulatory Affairs - for Peptide products or InjectablesLevel - Deputy Manager/ Associate ManagerRequired Education/Ex p:Experience Req.: 8 - 12 yrs.Qualification: - M. Pharma / M.Sc.Key Role- Formulation Regulatory Affairs for Peptide products or InjectablesResponsibiliti es:Drafting controlled correspondences, pre-development meetings...
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Regulatory Affairs Specialist
2 days ago
Bengaluru, India Biocon Full timeRole - Formulation Regulatory Affairs - for Peptide products or InjectablesLevel - Deputy Manager/ Associate ManagerRequired Education/Exp:Experience Req.: 8 - 12 yrs.Qualification: - M. Pharma / M.Sc.Key Role- Formulation Regulatory Affairs for Peptide products or InjectablesResponsibilities:Drafting controlled correspondences, pre-development meetings and...