Officer - RA (API)
2 weeks 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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Officer / Executive API Marketing
3 days ago
Mumbai, Maharashtra, India Unichem Laboratories Full time US$ 60,000 - US$ 1,20,000 per yearRESPONSIBILITIESManaging & preparing MIS for the API Marketing Team.Responsible for scheduling meetings efficiently and communicating to stake holder.Gather and analyze market data from various sources and generate market reports to support better functioning of marketing team.Responsible for the preparation of effective corporate presentations.Support in...
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Officer- Quality Control- API
1 week 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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Team Member/Manager
4 weeks ago
Mumbai, Maharashtra, India, Maharashtra Cipla Full timeJob Description:Title: Team Member/Manager – Intellectual Property Cell – APILocation: Vikhroli, MumbaiRoleSupport product development by providing timely IP inputs to relevant stakeholders (RA, R&D etc.) to ensure smooth product launch. Provide insights in patent litigation and opposition to align with product strategy in a cost effective...
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Compliance Officer
2 weeks 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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RA-Sr. Executive/ Executive
2 weeks 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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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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Compliance Officer
1 day ago
Mumbai, Maharashtra, India Equirus Full time ₹ 5,00,000 - ₹ 15,00,000 per yearJob Description:About EquirusAbout Equirus WealthEquirus is a leading mid‐market investment bank with strong practices around M&A, PE, Capital Markets, Institutional Equities, Wealth Management, Insurance Broking, and Portfolio Management Services.For more details you can visit us at Equirus Wealth is a holistic Wealth Management platform founded in 2018...
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Manager/ Sr. Manager
2 weeks 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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Mumbai, Maharashtra, India Job Search Full time ₹ 12,00,000 - ₹ 36,00,000 per yearUrgent opening for the profile of Sales & Marketing Manager (API) 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,...