Senior Regulatory Affairs Manager
4 days ago
Job Opportunity:Senior Regulatory Affairs Manager - US Market ExpansionThis position oversees the end-to-end preparation and submission of regulatory dossiers to the FDA, ensuring compliance with relevant guidelines and regulations. Key responsibilities include leading query responses, amendments, and post-approval submissions.The ideal candidate will possess a strong understanding of complex generics, including injectables and liquid dosage forms. Experience in preparing and submitting FDA meeting requests and packages is also essential.Strong leadership and team management skills are required to guide a team of regulatory professionals, providing guidance, training, and performance management. Effective communication with internal stakeholders and external regulatory bodies is crucial.Master's degree in Pharmacy or related fieldMinimum 13 years of experience in US Regulatory Affairs with proven track record in ANDA/NDA submissionsHands-on experience with FDA meetings, Controlled Correspondence, and post-approval changesStrong understanding of complex formulations and regulatory strategyExcellent written and verbal communication skillsDemonstrated leadership and team management capabilities
-
sangli, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
-
Regulatory Associate
2 days ago
Sangli, India Fusion Market Research Full timeTypical duties include: - studying scientific and legal documents to check they meet legal requirements. - gathering, evaluating, organising, managing and collating information in a variety of formats. - submitting information and responding to queries from bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA). - maintaining...
-
IT Compliance and Process Manager
1 day ago
sangli, India BDx Data Centers Full timeIT Compliance and Process ManagerCOMPANY OVERVIEWBDx is Asia's fastest-growing data center platform, delivering colocation, build-to-suit, managed services, and interconnection solutions for hyperscalers, large enterprises, and AI customers. Operating across high-growth markets—including Indonesia, Hong Kong, Singapore, and Taiwan—BDx currently boasts...
-
Data Center Operations Manager
1 day ago
sangli, India beBeeCompliance Full timeJob OpportunityThe Compliance and Process Manager role oversees adherence to regulatory, industry, and internal standards for data center operations across the APAC region.Main Responsibilities:Develop standardized processes for datacenter operations, including incident management, change management, and operational workflows.Identify process improvements to...
-
Chief Piping Engineer
21 hours ago
sangli, India beBeeEngineering Full timeSenior Piping Engineering LeadershipWe are seeking an accomplished piping engineer to oversee end-to-end engineering for marine & offshore projects, including FPSO, FSO, FSRU, rigs and shipbuilding/conversion.Direct comprehensive piping design & engineering activitiesReview process flow diagrams, piping & instrumentation diagrams, stress analysis & hydraulic...
-
Senior Engineer
21 hours ago
sangli, India Drydocks World Full timeWe're Hiring: Senior Engineer – Piping Location: Ghansoli, Navi Mumbai (Aurum Q Parc) Company: DP World – Dubai Drydocks World (DDW)We are looking for an experienced Senior Piping Engineer to lead basic and detailed engineering for marine & offshore projects including FPSO, FSO, FSRU, rigs and shipbuilding/conversion projects.Key Responsibilities:- Lead...
-
Senior Supply Chain Strategist
1 week ago
sangli, India beBeeSupply Full timeJob Title:Senior Supply Chain StrategistJob Description:The senior supply chain strategist plays a pivotal role in overseeing the entire supply planning process. This individual is responsible for developing and implementing effective strategies that ensure optimal inventory levels, meet customer demand, and drive business growth.Key Responsibilities:-...
-
Civil Engineer
3 days ago
Sangli, Maharashtra, India ARWADE INFRASTRUCTURE LIMITED Full time ₹ 20,00,000 - ₹ 25,00,000 per yearCompany DescriptionARWADE Infrastructure Limited is a leading EPC and Design & Build company specializing in Data Centers, Industrial Facilities, Warehousing Complexes, and Institutional Projects across India. As a preferred partner for global and Indian conglomerates, ARWADE excels in executing Greenfield and complex Brownfield projects with compliance to...
-
Sr. Team Member
7 days ago
sangli, India Star Union Dai-ichi Life Insurance Company Limited Full timeJob Description- Overall responsibility of monthly, quarterly, and annual preparation of financial statements- Periodical review of accounts to ensure a high standard and correct disclosure- Work with other team members to understand revenue and cost drivers and its accounting (i.e.. used in the allocation of indirect cost)- Liaison with internal and...
-
Senior Internal Auditor
3 weeks ago
Sangli, India Chronos Consulting Full timeSenior Internal AuditorLocation - MumbaiIndustry - Oil and GasThe Senior Auditor/ Assistant Manager, has the primary responsibility of conducting financial, operational, compliance, IT audits and special investigations across all of the company's operating divisions and affiliates.Responsibilities Would Include- Develop and execute a comprehensive risk-based...