Average salary: Rs549,999 /yearly
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- ...Description Sr Regulatory Consultant/ Regulatory Consultant (CMC- API - EU market) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development...SuggestedFull timeContract work
- ...and submit DMFs in compliance with global regulatory requirements including US (FDA), EU (... ...synthetic, semi-synthetic, and peptide APIs. • Ensure all submissions meet... ...Experience: Minimum 10 years in API Regulatory Affairs Add-ons: Well versed with MS PowerPoint...Suggested
Rs 5 - 9.5 lakhs p.a.
...Key Responsibilities Assist in preparation and submission of regulatory dossiers such as USDMF, CEP, and ASMF Handle amendments, annual reports, and lifecycle management of regulatory filings Respond to queries from regulatory authorities and ensure timely resolution...Suggested- ...world's leading supplier of active pharmaceutical ingredients (APIs), we partner with 80% of the top 50 global pharmaceutical... ...relevant guidelines. Routine support and collaboration with the Regulatory Affairs Associates team members in administrative activities related...SuggestedWorldwide
- ...EY- GDS Consulting Enterprise Risk (ER) Regulatory Compliance Manager Veeva RIM At EY were... ...tools. Familiarity with Veeva APIs Vault Loader and other integration tools... ...development with deep expertise in Regulatory Affairs and Regulatory information management system...SuggestedFull time
- ...together. The opportunity The Associate II, Complex Gx, Regulatory Affairs is responsible for the preparation and submission of high-quality... ...site transfers, formulation modifications, and alternate API sourcing. On occasion, serve as regulatory contact point for...SuggestedTemporary workWorldwideFlexible hours
- ...We are looking for a Regulatory Affairs Specialist Global Lifecycle Management (LCM) to support and manage postapproval regulatory activities across... ...patients around the world. We have End to end capabilities in API Formulations Clinical Intellectual Property and Regulatory...SuggestedFull timeRelocation packageImmediate startRemote jobWorldwide
- ...Position: DGM – QA Head (API Manufacturing) Reporting To: Quality Head Role Summary Lead the Quality Assurance function for the API manufacturing unit ensuring compliance with global regulatory standards including US Food and Drug Administration (USFDA) European...SuggestedFull time
- ...my knowledge. Job Description Qualification : B.E./ B Tech (Chemical Engineering) Experience : Minimum 8 to 10 years in API manufacturing Plant Job Responsibilities: Plan batches as per monthly production schedules allocate jobs across shifts and...SuggestedFull timeShift workWeekend work
- ...Senior Regulatory Affairs Officer - Vapi, Gujarat We are seeking a highly experienced and proactive Senior Regulatory Affairs Officer to join... ...is a leading specialist in Active Pharmaceutical Ingredients (APIs). We are a part of 50+ year-old group, currently exporting to...SuggestedPermanent employmentFull timeWorldwide
- ...Description Job Description We are seeking a detail-oriented Regulatory Affairs professional to join our team in Hyderabad, India. In this role... ...patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory...SuggestedRelocation packageWorldwide
- ...understanding business processes Pharmaceutical(API's) and the execution of business unit... ...complaints and co coordinating with Regulatory team to correspond with consultant and Health... ...Coordinate with teams including R&D, Regulatory Affairs, QA, QC, IPR, GST, Logistics, Finance, and...Suggested
Rs 4 - 8 lakhs p.a.
...business relationships with major U.S. customers in the Active Pharmaceutical Ingredients (API) sector. The role requires strong communication skills, a solid understanding of technical, regulatory, and commercial aspects of API manufacturing and export, and the ability to lead...SuggestedImmediate startRs 2.5 - 11 lakhs p.a.
...Key Responsibilities Prepare and submit regulatory dossiers for emerging markets, including Brazil, China, and LATAM. Participate... ...a related field. ~3-8 years of experience in regulatory affairs within the API/pharmaceutical industry. ~ Understanding of global...Suggested- ...companies.It specializes in generic drugs, active pharmaceutical ingredients (APIs), and biosimilars, and is among the top generic drug suppliers in the U.S. and Europe. Position - Regulatory Affairs (US market) Key Responsibilities: ~Hands on experience with RA-US market...SuggestedFull time
Rs 0.5 lakh p.a.
...API Sourcing for Formulation Position: Sr. Executive/ Asst. Manager Reporting To: Sourcing Head Location : Corporate, Hetero Nexity, Raidurg. Purpose: The role involves handling Sourcing & procurements of APIs for US, Europe and emerging markets of Injectable...- ...Role Summary The Assistant Manager – Domestic Marketing (API's) will be responsible for driving API sales in the Indian pharmaceutical market by managing customer relationships, generating business opportunities, executing pricing strategies, and ensuring end-to-end order...
Rs 2.5 - 5 lakhs p.a.
...Key Responsibilities: Establish, implement, and maintain GMP-compliant quality systems across the API manufacturing unit. Lead and participate in regulatory, internal, and third-party audits ; ensure timely closure of observations and CAPAs. Review and approve...- ...Position :-Regulatory Affairs -ROW Market (Formulation) Roles & Responsibilities : ~Preparation, Compilation and Review of dossiers in CTD/country... .... ~ Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation...
- ...Jubilant Ingrevia Limited Designation & Level: - Manager – Regulatory Affairs Location: - Corporate Office – Greater Noida Reporting... ...Ensure complete life cycle management of DMF /Dossiers for APIs/active ingredients/intermediates, such as DMF filing, access request...Contract workWork at office
- ...technology and AItocreate tomorrow to know us onLinkedInXYouTube andFacebook. Inviting applications for the role of Lead Consultant Azure API Management Service Support SME In this role you will collaborate closely with cross-functional teams including developers business...Full timeContract work
Rs 6 - 14 lakhs p.a.
...We are seeking a highly skilled Assistant Manager - Regulatory Affairs to specialize in the US market . The ideal candidate will have thorough... ...-review ANDA s within strict timelines. Coordinate with R&D, API vendors, and other cross-functional teams to gather necessary...Full time- ...Job Description Scientific review of external API vendor's DMFs in context of ANDA/NDA & resolving any gaps. Preparation & review... ...writing of deficiency responses, modules & other scientific regulatory documents, as required. Participation in project meetings, coordination...
- ...supervisor Maintaining cGMP standards, ISO 9001, ISO 14001 & HACCP standards in the plan Making sure that the premises and equipment are maintained and records kept Responsibility in Blending, packing, and labelling of finished goods . Skills: iso,api,finished goods
- Description : We are seeking a skilled API Automation Lead with minimum 6+ years of experience in both Automation and Manual Testing of REST APIs. The ideal candidate will have a strong background in API testing and automation frameworks, with a focus on delivering high-quality...
- ...Planning & Inventory Control (PPIC) Industry: Pharmaceutical API Manufacturing Experience: 5 Years (API Pharma Mandatory) Location... ...validation impact, and downtime. Ensure planning aligns with regulatory commitments and approved manufacturing processes. Material...
- ...our competitive edge in the market.Key Responsibilities : - Define and implement comprehensive test strategies and plans for functional, API, and microservices testing, ensuring alignment with project goals and timelines.- Lead and mentor a team of QA engineers, providing...
- Title: Executive - API Custom Field 2: 2869 Location: Bavla, Gujarat, IN Country/Region: IN State: Guja City: Bavla Company: Dishman Carbogen Amcis Limited Business Unit: General Travel Description: Prepare and review Standard Operating Procedures...
- Title: Executive - API QA Custom Field 2: 3013 Location: Bavla, Gujarat, IN Country/Region: IN State: Guja City: Bavla Company: Dishman Carbogen Amcis Limited Business Unit: General Travel Description: To perform IPQA Activity To Handle change...
Rs 2 - 3.5 lakhs p.a.
...Job description Role & responsibilities Perform Quality Inspections to verify finished API and identify defects. Inspect raw materials, in-process components, and finished API Products as per quality standards. Prepare and maintain inspection reports, test results...
