337 Regulatory Submissions Jobs - Page 13

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...

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...

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

Role & responsibilities Extensive Knowledge in Pre-Submission activity and handling new product submissions. Handling of post approval activities (US/EU and ROW) Experience in handling life cycle management Activities. Line Extension and New Submissions. Well versed in applicable regulatory and country specific guidlines.

Immediate Joining | Remote | | Part Time - Visiting Faculty Impart Training Sessions for the students of Drug Regulatory Affairs Weekend Training Sessions Prepare presentations Deliver Training Sessions

Hi We are hiring for Regulatory Submissions Publisher . Job Purpose: 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 complexities as assigned. Other submission ...