333 Regulatory Submissions Jobs - Page 12

Role & responsibilities Position: Regulatory Associate CMC Location: Remote (India) Were looking for passionate professionals ready to grow their careers in a dynamic, global organization. Role Requirements: Masters degree in Pharmaceutical Sciences Minimum 2 years of experience in regulatory, quality, or document management support Hands-on experience with CMC (pre- and post-approval) Familiarity with Module 1 document preparation and country-specific administrative forms Skilled in maintaining regulatory trackers, submission timelines, and status reports Strong interpersonal and communication abilities Proficient in Microsoft Office (Word, Excel, PowerPoint) Be a part of meaningful work th...

The Senior Associate, Global Submission Management – International, will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the international (ex-US and Canada) context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management ...

What you will do Let’s do this. Let’s change the world. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and countries. In this vital role you will interface with the Amgen Global, Site...

Role & responsibilities : Lead Regulatory Affairs department. Should be well versed with submission of Document in CTD/ACTD Format for Regulatory & ROW Market. Should be able to handle team. Preferred candidate profile Reputed Pharma background.

Continuously update knowledge of relevant regulations, guidelines, and industry standards. Ensure that products and processes adhere to all applicable regulations throughout the lifecycle, from development to post-market surveillanc Required Candidate profile Prepare, review, and submit regulatory documentation, including applications, reports, and amendments, to regulatory agencies. Prepare for and participate in regulatory audits.

Role & responsibilities : ISO 9001/ISO 13485. Manage the Quality Management System. To provide QA support in all quality related matters and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements. Risk Management & CAPA. Establishing procedures and records as per requirement of standards and regulatory authorities. Responsible for establishing, managing, and implementing Records Management policy, Records. Retention and retrieval procedures are in place. To manage and execute internal and external audit schedules and follow up on action plan, Quality Auditing of External suppliers - maintain an annual auditing program. Regular Internal Quali...

This Opportunity is with a leading Banking company for their office in Mumbai location Role: MIS & Regulatory Submissions - TM Experience: 10 - 15 Years Job Description: PURPOSE OF THE JOB: - Will be responsible for reporting of Complaints Performance which includes Closure TAT, Pendency and Top Areas of Complaints, different MIS on complaints to senior management and all regulatory submissions. As a control function, will be responsible to identify non-compliance to Complaint Management processes of the bank, incorrect selection of CRM fields, and to ensure corrective action/ process improvement. Roles & Responsibilities: KEY RESPONSIBILITIES: 6 - 8 Areas Actionable (4-6) Regulatory Reporti...

Manager - International Regulatory Lead Role Name Manager International Regulatory Lead (IRL) Department Name International Regulatory Team, Global Regulatory Affairs Role GCF5A ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. ABOUT THE ROLE Role Description: The International Regulatory Lead (IRL) Man...

Roles and Responsibility : To review and arrange required documents to corporate RA for dossiers, query response. To review artwork in artwork management system. R apply product permission, NOC for all manufactured product.R

About The Role : Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecy...

Kamla Homes is looking for Officer- RA to join our dynamic team and embark on a rewarding career journey Prepare regulatory submissions for product approvals Ensure compliance with domestic and global regulations Monitor regulatory changes and update dossiers Coordinate with QA and production for alignment

Role & responsibilities Job Description Deputy Manager/Manager DCGI Handling submissions in Sugam & NSWS Portal Preparation & Submission of New Drug applications, Subsequent New Drug Applications Clinical trial application - Phase I, II, III, IV (Form CT-04) BA/BE Export application (Form CT-05) Test License application (Form CT-10, Form CT-13, Form CT-14, Form CT-16, Form-11) Manufacturing new drug & Marketing (MA) application (Form CT-21) Import new drug & Marketing application (Form CT-18) Form-40 & Form-10 application Post approval changes RCGM Submission pre-clinical toxicity study of vaccines (Form C-1, Form C-3b) Dual use NOC application Import and export application of Narcotic & Psy...

What You Will Do: 1. AML/CFT Program Management manage the entire AML/CFT lifecycle including: Customer Identification Program (CIP) KYC/CDD/EDD reviews Sanctions screening & PEP checks Transaction monitoring & alert review Fraud detection and investigations Conduct enhanced due diligence (EDD) and oversee high-risk KYC/AML reviews. Review and approve alerts escalated from L1 analysts; guide in decision-making for borderline cases. Prepare and submit Suspicious Transaction Reports (STRs) to regulators (e.g., FIU- India) ensuring accuracy, completeness, and timeliness. Maintain up-to-date documentation, risk matrices, and control maps to reflect current threats and regulatory expectations. 2....

Job Description : Business: Piramal Critical Care Department: Regulatory Affairs Location: Kurla Travel: Low Job Overview Responsible for all artworks and labeling components of Piramal Critical Care Products Worldwide with adherence to the labeling processes, ensuring compliance with innovator labeling, internal & external partners, and GMP standards and specifications. Participate in a cross-functional team environment as necessary to ensure labeling documents and associated change requests are medically and scientifically accurate and that they comply with regulatory standards, meet company needs and accurately assess current strategy and global regulations Key Stakeholders: Internal Cros...

Role & responsibilities B.Pharma / M.Pharma candidates with 12--15years experience in Regulatory Affairs for Asia & Africa, CIS markets & ROW market wrt to Compilation of dossiers in CTD, eCTD & national ,Compilation and submission of queries and variations. Review of documents, artworks Review of change controls Gap analysis for variation filing and maintaining product Life cycle. Preferred candidate profile Reputed Pharma background

Reporting to Sr. Director - Regulatory Affairs Experience required: 5-8 Years Education: B. Pharm / M. Pharm Department: Regulatory Affairs Key Responsibilities: Prepare the status of all documents related to submission. Compile and review Regulatory submission documents required in line with the relevant guidelines. Coordinate with all stakeholders of the manufacturing plant for the collection of documents. Evaluation of change control: evaluate all post-approval changes. Review of specifications (API, Intermediate, FP, and Shelf life) executed BMRs, BPRs, COA, Method transfer report, Method verification, Analytical chromatograms intended for regulated or non-regulated market submission. Ge...

Key Responsibilities: Strong understanding of eCTD, NeeS, and ICH guidelines. Familiarity with Regulatory systems and Publishing tools. Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint. Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier compilation, and dispatch of submissions to respective Health Authorities (Developed and ROW Markets) Manage lifecycle submissions including variations, amendments, and renewals. Perform document-level publishing, hyperlinking, bookmarking, and validation. Conduct quality control checks to ensure submission readiness. Collaborate with cross-fun...

Preparation & compilation of Dossiers Knowledge of UK & EU Market, CTD Review of Artwork. Registration of renewal of products Solve Queries & Timely compile materials for license renewals, updates and registration Review changes to existing products

About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in so...

work: Expert in regulatory compliance Oversee RBI reporting, guidelines adherence & risk management Manage government affairs, liaison & relations FEMA expertise Escrow & Consortium Knowledge Biz Development & Management Communication skills Annual bonus Health insurance

#Hiring Regulatory Affairs Manager for one of the reputed MNC into Healthcare industry. Position Title: Regulatory Affairs Manager Location: Gurugram About Role:- The Regulatory Affairs Manager will be responsible for managing the regulatory strategy and ensuring the compliance of medical devices/IVD with applicable regulations. The candidate should have relevant years of experience in Regulatory Affairs. Preferably, complete knowledge of Indian Regulatory Requirements with in-depth understanding of D&C Act, MDR 2017& BIS. This role involves working closely with cross functional team. The manager will monitor regulatory changes, support product submissions, and ensure timely approvals to mai...

Roles and Responsibilities Prepare dossiers, variations, renewals, and amendments for regulatory submissions to FDA and other global health authorities. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Maintain accurate records of all regulatory correspondence, reports, and audit findings. Ensure compliance with regulatory guidelines and requirements by reviewing documentation and conducting internal audits. Provide support during regulatory audits by gathering necessary information and preparing responses. Desired Candidate Profile 1-4 years of experience in Regulatory Affairs or related field (pharmaceutical industry). Bachelor's degree in Pharmac...

Regulatory Affairs Manager in Clinical Research @ Vimta Labs Ltd, Hyd Experience: 8-12 years of Regulatory Affairs experience in Clinical Research Industry. CTC: Based on their current CTC. Job Description Regulatory Affairs Manager Primary Responsibilities: 1.. Manage the activities of Regulatory Affairs for clinical research and ensure the implementation of effective regulatory strategies. 2. CDSCO, CBN and NCB getting approvals as required for Vimta. 2. Provide regulatory input to strategic decision making; including prioritization, and external communications 3. Provide regulatory input to in-licensing evaluations and due diligence activities 4. Provide advice about regulations to manufa...

The Senior Associate, Global Submission Management – Americas, will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the North American context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management and Regulatory submissi...

Manager - International Regulatory Lead Role NameManager – International Regulatory Lead (IRL) Department NameInternational Regulatory Team, Global Regulatory Affairs Role GCF5A ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description: The International Regulatory Lead (IRL) Man...