337 Regulatory Submissions Jobs - Page 14

What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions in the Regulatory and Clinical Trial submission product team that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers supporting applications like docuBridge Suite from Lorenz and Disclose from Citeline, developing scalable solutions, automating operations, monitoring system health, and responding to incidents to minimize downtime. The ideal candidate will have a strong backgrou...

Hi, We are hiring for leading ITES Company for Narrative Medical Writing Profile . Job Description Build and process submission dossiers of low-to-moderate complexity: Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.). QC submission dossiers or parts of submission dossier output of low-to- moderate and moderate-to-high complexitie...

Role & responsibilities Asst Manager / Sr. Executive - Regulatory DRA DEPT- Europe Market @ Pharma Formulation -PUNE City. Person will be responsible for DRA function for Pharma Formulation for Advanced Markets / EU The candidate should be conversant with preparing dossiers for Finished Formulations for EU. Preferred candidate profile Honest, Hard Working. Growth Mindset (Important). Good Communications Skills. Relevant Experience in Pharma Only Candidate with Relevant Experience may apply. We also encourage rightful candidates to write directly to us to "info@vekocare.com" with a proper covering note.

We are hiring an International Regulatory Affairs Executive/Manager with expertise in regulatory documentation, CTD dossiers & query handling. Immediate joiners preferred. Candidates with 1+ year experience may also apply. Join our growing team!

Expertise in API / Formulation regulatory compliance across EU/ROW regions Sound knowledge of Drug Substance control strategies Familiarity with global regulations: ICH, FDA, EMA, USFDA etc Skilled in responding to Ministry of Health (MoH) queries Required Candidate profile M. Pharma / B. Pharma / M.Sc / B.Sc with 7 to 15 Years Experience Deep Knowledge of Regulatory Affairs Compliance And Procedures Must be able to work independently And Head Team of junior Officers

Audit & Risk Management To support in the preparation, implementation and monitoring of the SOP's related to Health safety & Environment practices across all AIS Plants. Standardization & horizontal deployment of best practices. Plan and coordinate internal and third-party EHS audits across all units. Track, review, and follow up on audit findings, incident investigations, and corrective actions. Support plants in conducting risk assessments and HIRA/JSA exercises. 1. No of non compliances in internal/external audits 2. Audit score 3. No of Trainings EHS Data Management & Reporting: Consolidate and analyze EHS KPIs from all units. Prepare monthly/quarterly corporate dashboards and presentati...

Job Purpose: To lead and support regulatory operations for agrochemical products across the Asia Pacific region, ensuring compliance with local regulations, facilitating product registrations, and enabling market access. This role is critical in aligning regional regulatory strategies with global business objectives. Regulatory Compliance & Strategy Monitor and interpret regulatory requirements for agrochemicals (e.g., pesticides, herbicides, fertilizers) across APAC countries. Develop and implement regulatory strategies to support product launches and lifecycle management. Liaise with regulatory authorities and industry bodies to stay ahead of regulatory changes and advocate for science-bas...

Review and analyse information from the general ledger and other accounting records to ensure accuracy and completeness, taking corrective action as necessary. Manage compliance with R2R accounting standards across the group. Identify gaps in finance processes that may have been overlooked, mitigating potential material reporting issues. Challenge and hold senior finance managers and staff accountable in instances where inappropriate accounting is detected. Lead and support the team, providing guidance to help members achieve established goals and KPIs. Consistently adhere to all deadlines. Prepare and review balance sheet analyses and reconciliations, review profit and loss statements, and ...

We are seeking a highly skilled and experienced professional for the role of Design Quality Assurance (DQA) in Pune. The ideal candidate will have a strong background in quality management systems, regulatory compliance for medical devices, and hands-on experience with statistical tools and project management. This role is critical in ensuring product quality and regulatory adherence for Class II and III medical devices. Key Responsibilities: Ensure compliance with ISO 13485 , ISO 14971 , and other relevant quality standards. Oversee design assurance, design control, verification, and validation activities. Support regulatory submissions and audits for Class II and III medical devices. Utili...

We are seeking a highly skilled and experienced professional for the role of Design Quality Assurance (DQA) in Pune. The ideal candidate will have a strong background in quality management systems, regulatory compliance for medical devices, and hands-on experience with statistical tools and project management. This role is critical in ensuring product quality and regulatory adherence for Class II and III medical devices. Key Responsibilities: Ensure compliance with ISO 13485 , ISO 14971 , and other relevant quality standards. Oversee design assurance, design control, verification, and validation activities. Support regulatory submissions and audits for Class II and III medical devices. Utili...

Responsibilities: Operate, monitor, and optimize Effluent Treatment Plant (ETP) and Sewage Treatment Plant (STP) processes to ensure compliance with discharge norms. Ensure environmental compliance under CPCB, SPCB, MoEFCC, and other regulatory bodies. Prepare and maintain all necessary records related to Hazardous Waste Management, Water/Air Consent, and Environmental Audits. Manage liaisoning activities with government authorities for timely approvals, renewals, and inspections (e.g., Pollution Control Board, Factories Department, etc.). Lead initiatives related to sustainability, energy saving, and pollution prevention. Conduct environmental impact assessments (EIA) and periodic internal ...

Tracking of Regulatory emails and ensuring revert has been provided to Exchange Insider Trading Regulation Approvals Advertisement approvals Regulatory Submissions - Exchanges and Depositories ================================================= Educational Qualifications: Graduate/Post Graduate Experience: 5 to 6 year experience in Broking firm Domain Knowledge: Broking Industry, SEBI Regulations NISM IIIA to be cleared mandatorily