
Officer - RA (API)
6 days ago
- Review of outsourced DMF and deal with suppliers for adequate data for ANDA/MAA/ ANDS filings.
- Responsible for arranging the documentation required for regulatory submissions to US/Europe/ all other geographies - new DMF submissions Amendments, Response to Deficiencies.
- To provide Regulatory inputs during product development, manufacturing, and testing and to evaluate all types of change proposals during product life cycle.
- Responsible for evaluating the regulatory impact for the change notifications received from Outsource API vendors.
- Participate in selection process of supplier through audits from regulatory compliance viewpoint for new supplier & AVD.
2-3 Years in API Regulatory Affairs
DMF filing and handling regulatory agency queries
EducationMasters in Chemistry Competencies
Customer Centricity Developing Talent Collaboration Strategic Agility Process Excellence Stakeholder Management Innovation & Creativity Result Orientation
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Mumbai, Maharashtra, India Kopran Full time ₹ 9,00,000 - ₹ 12,00,000 per yearRole & responsibilitiesPreparation of DMFs for regulated (US, EU) & ROW markets.Preparation of lifecycle management submissions (amendments / revisions) for the filed DMFs.Preparation of response to deficiencies from regulatory authorities & customers.Coordination with cross functional teams for data / documents.Preferred candidate profileCandidate should be...
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Executive Director
4 days ago
Navi Mumbai, Maharashtra, India beBeeMarketing Full time ₹ 6,00,000 - ₹ 12,00,000Job Title: Marketing Executive in Pharmaceutical API IndustryWe are seeking a skilled professional to support our Business Development efforts in the API industry. The successful candidate will be responsible for communicating with customers, coordinating with Plant, QA, and R&D teams, and presenting marketing materials.Main Responsibilities:Support Manager...
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Navi Mumbai, Maharashtra, India Seven Consultancy Full timeJOB DETAILS 1) Support Manager Business Development in API Marketing efforts with Indian domestic market & Regulated market customers in India.2) Should be able to handle communication independently with customers & satisfy their requirements by co-ordinating with Plant , QA and R&D.3) Good Communication skills, both verbal & written Previous experience in...
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Navi Mumbai, Maharashtra, India Seven Consultancy Full timeJOB DETAILS 1) Support Manager – Business Development in API Marketing efforts with Indian domestic market & Regulated market customers in India.2) Should be able to handle communication independently with customers & satisfy theirrequirements by co-ordinating with Plant,QA and R&D.3) Good Communication skills, both verbal & written.4) Previous experience...
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API Lifecycle Specialist
1 day ago
Mumbai, Maharashtra, India beBeeApi Full time ₹ 15,00,000 - ₹ 28,00,000Job Overview We are seeking a skilled professional to fill an exciting opportunity in API lifecycle management. This role will be responsible for monitoring and documenting the health of IBM API Connect v10 subsystems and Datapower v10 servers, as well as analyzing services logs to identify problems within the environment. Additional responsibilities include...
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Senior Manager
2 weeks ago
Mumbai, Maharashtra, India Sun Pharmaceutical Industries Full timeJob Title Manager Sr Manager -Global Procurement - APIJob GradeG10 G9BFunction Global ProcurementManager s Job Label DGMLocation Acme Plaza-Andheri MumbaiNo of Direct Reports if any NAAreas Of Responsibility Responsible for supporting Global procurement for API for Therapy category - ARV Anti-cancer Anti Inflammatory and Anti-Allergy Skin related...
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Officer- Quality Control- API
3 days ago
Navi Mumbai, Maharashtra, India Takeda Full time ₹ 1,04,000 - ₹ 1,30,878 per yearOfficer Quality Control - API & IntermediatesEducation - M.SC - Analytical / OrganicExperience 1 to 3 years experience in Quality Control from pharmaceutical industry.(This is a Fixed Term Contract role - On Company's Contract)Job Description -Sampling of raw, packing material, intermediate & finished product.Analysis of raw, packing material, intermediate,...
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Compliance Officer
7 days ago
Mumbai, Maharashtra, India Octanom Tech Full time ₹ 3,00,000 - ₹ 7,00,000 per yearCompany Overview:Octanom Tech Private Limited is a leading Invest Tech firm that operates , India's first 'Hedged-Style' trading and investing platform. We are focused on minimizing losses rather than maximizing profits, utilizing advanced AI technology to efficiently manage risk across financial instruments. As a SEBI- registered Research Analyst (RA) firm,...
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API Lifecycle Operations Specialist
1 week ago
Mumbai, Maharashtra, India beBeeAPILifecycle Full time ₹ 1,04,000 - ₹ 1,30,878Job Title: API Lifecycle SpecialistAre you passionate about ensuring seamless API operations? We're looking for a skilled specialist to join our team and help us maintain the highest level of service quality.Key Responsibilities:Monitor and analyze IBM API Connect v10 subsystems and Datapower v10 servers health and services logs on an hourly basis to...
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Chief Compliance Officer
6 days ago
Mumbai, Maharashtra, India beBeeQuality Full time ₹ 1,20,00,000 - ₹ 1,50,00,000Job DescriptionThe Senior Manager – API Cluster Support role is responsible for ensuring compliance with regulatory standards across all API manufacturing sites.This involves monitoring and improving quality systems, facilitating quality management reviews, and driving continuous improvement initiatives.