cmc

JOB DESCRIPTION Position : Project Engineer – Department : Construction Management & Project Management Consultancy (CMC/PMC) Reporting To : Project Manager – CMC / CMC Head Location: Baramati Experience • 3–10 years of experience in construction supervision, PMC, project coordination, quality monitoring, or site management. • Experience in...

DescriptionLead and manage SAP Project Systems implementations, ensuring successful delivery within timelines.Configure SAP PS modules focusing on cost planning, budgeting, and project execution.Collaborate with cross-functional teams to integrate SAP PS with FM, HR, and PP modules.Utilize SAP Activate methodology and Agile delivery models to improve project...

• Lead and manage SAP Project Systems implementations, ensuring successful delivery within timelines. • Configure SAP PS modules focusing on cost planning, budgeting, and project execution. • Collaborate with cross-functional teams to integrate SAP PS with FM, HR, and PP modules. • Utilize SAP Activate methodology and Agile delivery models to improve...

Regulatory Manager (CMC and Biologics)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 and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical...

This job is with Pfizer, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Functions as a CMC strategist for the development of CMC regulatory strategies, submissions and compliance activities for commercial pharmaceutical products supporting HBU's...

This position, Manager in Global Regulatory Affairs LCM CMC, is a project-facing CMC position supporting life-cycle management. Regulatory Execution • Prepare, review, and submit post-approval CMC regulatory filings, including:• Variations (Type IA/IB/II) • Supplements (PAS, CBE-30, CBE-0) • Annual reports and renewals • Ensure submissions meet...

Regulatory Manager (CMC and Biologics) 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 and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical...

Job Title: CMC Regulatory Affairs (Biologics) – Executive to Manager Company: Enzene Biosciences Ltd. Location: Bhosari, Pune (On-site) Employment Type: Full-time Experience: 3–15 years Function: Regulatory Affairs About Enzene Enzene Biosciences is a biopharmaceutical CDMO focused on biosimilars and biologics. Our EU-GMP certified facilities in Pune...

Job Title: International CMC Regulatory Affairs Manager IGlobal Career Level: DRole Type: Individual Contributor for International MarketsAbout AstraZenecaAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines targeting some of the planet’s...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for...

Location : Hybrid (Hyderabad/Bangalore)Experience : 6-8 YearsRole SummaryThe CMC Solutions Engineer will design and build the semantic and technical foundation for CMC data, with focus on two areas: developing the CMC ontology and knowledge model, and engineering automated, GxP-relevant stability data workflows. Starting with stability monitoring data from...

Job Description – Senior Scientist (CMC): Role Summary: Senior Scientist responsible for API/NCE process development for regulated and semi‑regulated markets, with strong involvement in non‑infringing route design, scale‑up, regulatory filings, and cost‑effective technology transfer from lab to plant. Key Responsibilities: · Directed a team of...

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Job Description Work Experience Review of CMC related documents received from various inter functional departments and provide necessary inputs as per regulatory requirements. Preparation of CMC sections, compilation and review of dossiers as per country specific requirements. Track collection of all dossier/information from all concerned departments and...

Career CategoryRegulatoryJob DescriptionLet’s do this. Let’s change the world. In this vital role you will report into the Regulatory Compliance Team lead.The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific...

Key Responsibilities: Regulatory Submissions & Documentation • Prepare, review, and submit high‑quality regulatory dossiers (IND/IMPD, BLA/MAA, ANDA/Abbreviated MAA where applicable) for global markets including USFDA, EMA. • Ensure accuracy and completeness of CTD/eCTD modules, with strong focus on CMC documentation for biologics/biosimilars. •...

Job Description: Job Description:1. Work in SAP BW and BO support Projects.2. Monitoring Process Chains and Loads in BW3. Monitoring BO publications in CMC4. Work Experience in Bex Analyser, Bex Query5. Identifying Cost Centres and Reports to add to reports.6. Work experience in BO CMC7. Knowledge in BPC and BPC Process Chains8. Resource must work in...

Job Description Work Experience Review of CMC related documents received from various inter functional departments and provide necessary inputs as per regulatory requirements. Preparation of CMC sections, compilation and review of dossiers as per country specific requirements. Track collection of all dossier/information from all concerned departments and...

Job Description – SAP BusinessObjects Consultant (6–10 Years) Role snapshot FieldDetail Job titleSAP BusinessObjects (BO) Consultant / Senior Consultant Experience6–10 years total; minimum 3 years hands-on in SAP BusinessObjects Notice periodImmediate to 15 days preferred Role summary An experienced SAP BusinessObjects consultant is required to design,...