
Officer - RA (API)
4 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 ₹ 15,00,000 - ₹ 25,00,000 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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RA officer
2 weeks ago
Mumbai, Maharashtra, India Chemill Pharma Ltd. Full time ₹ 4,00,000 - ₹ 8,00,000 per yearRole is for individual contributor + working independently with minimumsupervision.Handson experience of CTD Dossiers & HA Queries– compilation/review/submission.Preparation of Pack Insert (PI)/ PILReview/ approval of Artworks.Peer review of technical documentsStrong follow up with external manufacturer so as to get submissiondocs/ samples on time through...
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Officer- Quality Control- API
2 days ago
Navi Mumbai, Maharashtra, India Takeda Full time ₹ 6,00,000 - ₹ 12,00,000 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
1 week ago
Mumbai, Maharashtra, India Octanom Tech Full time ₹ 42,00,000 - ₹ 84,00,000 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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Manager Marketing API
2 weeks ago
Mumbai, Maharashtra, India Job Search Full time ₹ 15,00,000 - ₹ 28,00,000 per yearUrgent opening for the profile of Manager Marketing API (Domestic) at location Thane(w).Qualification: Bachelors degree in Business, Computer Science, Engineering, or a related technical field (preferred)B Pharma/ B.SC chemistry with MBA / PG in sales and MarketingExperience: 8+ years of experience selling technical solutions (APIs, middleware, SaaS,...
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API - Business Development and Sales Executive
6 hours ago
Mumbai, Maharashtra, India CHEMET Full time ₹ 8,00,000 - ₹ 12,00,000 per yearJob Description Sales Executive – Pharmaceutiacal APIs & excipients:- The candidate should be B Sc / B Pharm graduate, having 2-5 years' experience in business development and sales activities in pharmaceutical – API (active pharmaceutical ingredients) and excipients field. Knowledge on imports & regulated market documentation support...
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RA-Sr. Executive/ Executive
4 days ago
Mumbai, Maharashtra, India Sai Placement Full time ₹ 12,00,000 - ₹ 60,00,000 per yearNote: Walk In Interview at MumbaiDate: Saturday)Designation:- Sr. Executive/ Executive /Sr. Officer / OfficerQualification:- M.Sc / M.PharmExperience:- 2 to 11 YearsJob Location:- Mumbai Required Candidate profile2 -11 years of experience in pharmaceutical regulatory affairs, guidelines including FDA, EMA, and ICH regulations.Market : US, Europe, South...
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Manager/ Sr. Manager
1 week ago
Mumbai, Maharashtra, India Sun Pharma Full time ₹ 15,00,000 - ₹ 30,00,000 per yearHi,We are having an opening for Manager/ Sr. Manager -Global Procurement - API at our Andheri location.Areas Of Responsibility :Responsible for supporting Global procurement for API for Therapy category - ARV, Anti-cancer, Anti Inflammatory and Anti-Allergy , Skin related for all market like regulated, EM and Domestic market.Alternate vendor development of...
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Manager / Sr. Manager - CQA (API)
3 weeks ago
Mumbai, Maharashtra, India USV PRIVATE LIMITED Full timeUSV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors. We have a presence in over 65 countries with our dynamic team of over 7,000 across generations. Our commitment to brand building is evident in our popular products like Glycomet GP, Ecosprin AV, Jalra, Tazloc, Glynase, MVI and more.Join USV and be part of our journey as...
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Manager / Sr. Manager - CQA (API)
4 weeks ago
Mumbai, Maharashtra, India USV PRIVATE LIMITED Full timeUSV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors. We have a presence in over 65 countries with our dynamic team of over 7,000 across generations. Our commitment to brand building is evident in our popular products like Glycomet GP, Ecosprin AV, Jalra, Tazloc, Glynase, MVI and more. Join USV and be part of our...