333 Regulatory Submissions Jobs - Page 3

Location Hyderabad, India Novartis is unable to offer relocation support for this role please only apply if this location is accessible for you About The Role Are you passionate about driving clinical trial excellence from the ground upNovartis Global Drug Development is seeking a dynamic Study Start-Up Lead to spearhead global SSU activities, ensuring timely site activation and regulatory submissions This is your opportunity to lead cross-functional teams and make a meaningful impact in global health innovation About The Role Key Responsibilities Lead global SSU planning and execution to enable timely site activation and regulatory submissions Configure and manage SSU systems including CTMS...

As the Manager Regulatory Affairs at Kenvue, you will lead a team responsible for developing regulatory strategies across India, providing guidance on local requirements to product development teams. Your responsibilities will include managing regulatory deliverables for various products within your geographical and brand area, ensuring consistency in regulatory positions, and maintaining current products throughout their lifecycle. You will also represent the Regulatory Affairs function within the Franchise. Key Responsibilities: - Provide regulatory input and guidance to product development teams - Support business initiatives by influencing and approving the product portfolio - Conduct ri...

As a Clinical Study Manager, you will be responsible for developing clinical study designs, writing study protocols, and monitoring plans. You will play a crucial role in training the study team on relevant aspects of clinical studies and ensuring the proper execution of statistical and data management plans. Your key responsibilities will include: - Developing clinical study design - Writing clinical study protocols - Writing study monitoring plan - Training study team on relevant parts of clinical studies - Ensuring statistical plan and data management plan are properly performed - Ensuring study risk analysis plan is properly executed - Designing CRFs (case report forms) and ensuring they...

As a Regulatory Affairs Specialist at Apotex Inc., you will be responsible for managing the product life-cycle of Apotex products in identified markets. Your duties will include maintaining documentation/database records, leading regulatory affairs projects, and preparing submission and approval notifications for applications submitted to Regulatory agencies. Key Responsibilities: - Provide support and regulatory guidance to a team in completing projects supporting regulatory submissions. - Prepare and review quality regulatory PLCM submissions for various markets to ensure timely approval. - Maintain and complete regulatory documents to support regulatory compliance in various markets. - As...

As an Intern at Mosaic Wellness, you will have the exciting opportunity to assist in the formulation development of cosmetic and personal care products such as Skin Care, Hair Care, and Baby Care. Your day-to-day responsibilities will include: - Assisting in formulation development of new and existing cosmetic and personal care products. - Supporting lab-scale trial batching, ingredient weighing, and assisting in testing activities like stability studies, accelerated aging trials, and pH/viscosity monitoring. - Participating in sensorial evaluation, claim support testing, and comparative benchmarking. - Aiding in the documentation of formulation records, batch sheets, and technical data. - S...

Job Summary Responsible for preparing and submitting regulatory filings to support the registration and lifecycle management of recombinant products in global markets. Ensures regulatory compliance by collaborating with cross-functional teams and maintaining up-to-date regulatory documentation and systems. Key Responsibilities Prepare and compile regulatory submissions including IND, IMPD, CTD dossiers, and briefing books for global product registrations. Update dossiers covering Administrative, CMC, and Clinical information; respond to regulatory agency queries in a timely manner. Track and maintain regulatory registrations and product lifecycle data to ensure compliance with global regulat...

Responsibilities: Dossier Preparation & Submission Prepare, compile, and review CTD / ACTD / eCTD dossiers for product registration in global markets. Coordinate for ANDA, DMF, CEP, COS, and other regulatory submissions for APIs and formulations. Ensure accuracy and completeness of Module 15 in line with specific regulatory authority requirements. Regulatory Compliance & Communication Ensure continuous regulatory compliance of products as per cGMP and ICH guidelines. Review and submit annual reports, amendments, variations, and renewals as required. Communicate with regulatory agencies and address queries, deficiencies, and clarifications (Q&A) in a timely manner. Documentation & Data Collec...

Responsibilities: Supports the Northern Cluster team (as appropriate) for UK, Ireland, Malta, Sweden, Finland, Norway, and Denmark products across the product portfolio. Supports the team with regulatory strategies (local and regional) that are in line with the business plan Supports the team with regulatory activities for National and/or European procedures (Decentralized, Mutual Recognition) as appropriate. For example, but not limited to: Prepares and compiles regulatory submissions, response to questions, renewals, post submission/approval activities (including relevant updates to external websites such as emc, medicines.ie and In-Demand) Supports ad hoc projects (e.g., compliance review...

As a Biostatistician at the company, you will play a vital role in cross-functional development teams by contributing to various aspects of trial design, protocol development, analysis planning, interpretation of results, and regulatory submissions. Your main responsibilities will include: - Developing collaborative relationships with team members such as the GBDS Biostatistics Lead, medical monitor, protocol manager, data manager, and PK scientist. - Making strategic and scientific contributions at the indication/protocol/integrated analysis level to enhance understanding of the asset being studied. - Driving the selection of optimal study designs, data collection methods, analytic approach...

Supporting activities for corporate transaction, group wide accounting, transactions regarding financial statements and managing documentation Job Title Deputy Manager - Finance Job Description Perform general accounting support and month end activities. Preparation of financial statements, reporting / highlighting deviations Inter and intradepartmental communication - Liaise with respective business units for relevant reporting and accounting activities Prepare and review documentation for intergroup reporting and accounting activities Preparation of month / year end reports and analysis for group / subsidiaries Balance Sheet / General Ledger data analysis and providing support for necessar...

Job Title Manager 2 MSTG Non Orals Business Unit R&D1 Regulatory Affairs Job Grade G11A Location : Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you'll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other's journeys. Job Description Process Development and Optimization Support:(PRIMARY) ...

As a Medical Information Associate at Fortrea, your primary responsibilities will include: - Responding to medical information queries, product quality complaints, and general queries in French over various communication channels such as telephone calls, emails, and faxes on a 24x7 shift basis. - Recording and reporting Adverse Drug Reactions promptly and in compliance with regulations and internal WI/SOPs. - Executing drug safety data management processes involving call intake, call dialogue documentation, peer review, and case follow-up. - Supporting various assigned activities including tracking information and metrics, quality control of process steps, training, and data reconciliation f...

Role Overview: As a Senior Technician Quality Control at Beckman Coulter Bangalore Development Centre, you will be responsible for conducting routine analysis of raw materials, in-process, and finished goods under supervision. Your main task will be to ensure compliance with Quality control procedures and activities according to 21 CFR 820, ISO 13485, ISO 9001, MDSAP, and Beckman Coulter corporate Quality system requirements. Your duties will include: Key Responsibilities: - Conduct routine analysis of raw materials, in-process and finished goods under supervision and in accordance with Standard Operating Procedures (SOPs). Compile data for documentation of test procedures and prepare report...

As a Regulatory Affairs Specialist, you will be responsible for maintaining accurate records of regulatory submissions, approvals, and correspondence with regulatory agencies. You will have the following key responsibilities: - Prepare, review, and submit regulatory documents, including applications, reports, and renewals, to relevant regulatory agencies. - Determine the types of regulatory submissions or internal documentation required for situations such as proposed device changes. - Develop and implement regulatory strategies to ensure compliance with domestic and international regulatory requirements. - Monitor regulatory changes and updates closely, assess their impact on current and fu...

Role Description This is a full-time, on-site role for a Regulatory Affairs Manager located in Roorkee. The Regulatory Affairs Manager will be responsible for ensuring compliance with regulatory requirements, overseeing regulatory submissions, and maintaining the quality system. The role involves monitoring and interpreting regulatory changes, developing regulatory strategies, and providing regulatory guidance throughout product development and manufacturing. Qualifications Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs skills Experience with Regulatory Submissions Knowledge of Quality System regulations Excellent written and verbal communication skills Attention to d...

Sr Manager - Gen Med Biosims International Regulatory Lead The Senior Manager of Regulatory Affairs at Amgen oversees regulatory compliance initiatives within the company. They are responsible for ensuring all company procedures and products adhere to state and federal regulatory requirements. Group Purpose International Regulatory Affairs provides regulatory leadership/ expertise for the development, registration, and lifecycle management of all Amgen molecules. Job Summary The International Regulatory Lead (Sr. Manager) is assigned to lead one or more Amgen products. The product(s) assigned have complex programs/strategies and high impact to Amgen. Provide Guidance and Leadership on mechan...

The Global Regulatory Policy & Intelligence (GRPI) group at Amgen engages with regulators, industry associations, and other stakeholders externally, and internally it manages regulatory intelligence for GRAAS monitoring, analyzing, and communicating regulatory requirements worldwide to enable fast, efficient global filings. The Senior Manager, as part of this team, plays a pivotal role in executing the regulatory intelligence function. Key Responsibilities: Regulatory Intelligence Deliverables: Contribute to the monitoring and analysis of the global regulatory landscape and develop agreed intelligence deliverables under the supervision of the Regulatory Intelligence Director. This includes p...

Position Regulatory Consultant Company Information Our client is a reputed Pharmaceutical Consulting firm working in the area of GMP and Global Regulatory Affairs. They have their head office in Mumbai and subsidiaries in Singapore, Malaysia, Australia and in Europe. The company has been providing high quality & timely consulting service to the Pharmaceutical Industry in India and internationally. The company has a young and committed team of GMP and Regulatory Experts. The company is inviting applications for the role of Regulatory Consultant and are looking for dynamic, driven individuals with strong initiative who can thrive in the entrepreneurial environment at our firm. Role & Responsib...

Role Description: The International Regulatory Lead (IRL) Sr Associate will provide coordination and execution of regulatory deliverables for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to optimize product development and regulatory approvals in International countries develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities: With support, advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Lia...

What you will do In this pivotal leadership role, you will guide the integration of data into Amgens Veeva Vault Platform, shaping and executing strategies and solutions to support these efforts. Collaboration across both cross-functional and global teams will be essential to ensure the smooth execution of integration and operational activities. The ideal candidate brings a record of effective leadership within technology-driven settings, expertise in managing enterprise platforms, and a dedication to advancing digital transformation in biotechnology. Success in this position requires the ability to champion critical organizational initiatives, nurture a culture of collaboration, and achieve...

Role Name: Manager International Regulatory Lead (IRL) Department Name: International Regulatory Team, Global Regulatory Affairs Role GCF: 5A ABOUT THE ROLE Role Description The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to -optimize product development and regulatory approvals in International countries -develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities -Advises Global teams on regulatory impl...

Job Summary: Amgen is seeking a Manager, Regulatory Affairs CMC Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a meaningful impact on regulatory efficiency and compliance. Join us in revolutionizing regulatory submissions through cutting-edge data automation! Key Responsibilities: Support the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows. Assist in developing standardized templates a...

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. Amgens CMC submission execution team, R egulatory O ptimization o f T actical and S trategic S upport (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC and/or Device submission execution for Amgen products across phases of development, modality and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC t...

We are M&G Global Services Private Limited (formerly known as 10FA India Private Limited, and prior to that Prudential Global Services Private Limited). We are a fully owned subsidiary of the M&G plc group of companies, operating as a Global Capability Centre providing a range of value adding services to the Group since 2003. At M&G our purpose is to give everyone real confidence to put their money to work. As an international savings and investments business with roots stretching back more than 170 years, we offer a range of financial products and services through Asset Management, Life and Wealth. All three operating segments work together to deliver attractive financial outcomes for our c...

Job Title Manager-2 - FR &D Non-Orals (Compliance group) Business Unit R&D1 Regulatory Affairs Job Grade G11A Location : Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you'll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other's journeys. Job Description Review documents required for reg...