454 Regulatory Submissions Jobs - Page 3

Key Responsibilities: 1. Develop the global regulatory strategies for biologic products across all development phases (preclinical to post-marketing) for the (US, EU, and ROW). 2. Ensure alignment with business goals and regulatory requirements across the different regions. (FDA, EMA, emerging markets). 3. Prepare, review, and manage high-quality regulatory submissions including INDs/IMPDs, BLA/MAA, CTA, DSUR, Annual Reports, as applicable. 4. Post-approval changes (variations, amendments). 5. Liaise with global regulatory agencies to facilitate product approvals and resolve queries. 6. Collaborate with R&D, Quality, Clinical, and national regulatory teams to ensure regulatory compliance acr...

In Recare Electrical LLP, you will be part of a team of highly experienced professionals in the energy sector, dedicated to sustainable growth through technical expertise and business insight. Specializing in Power Solutions, Renewable Energy, Energy Efficiency, and Electric Vehicles, the company upholds principles of transparency, quality, and human values while focusing on creating employment opportunities. Your role will be based in Surat, with some remote work flexibility. Key Responsibilities: - Manage and oversee regulatory compliance for solar power projects - Ensure adherence to regulatory requirements - Handle submissions to relevant authorities - Analyze policies and monitor regula...

As a Senior Manager of Benefit Risk Assessment Operations at Bristol Myers Squibb, you will be responsible for collaboratively authoring and revising key drug safety-focused documents to support upcoming submission documents to Regulatory Health Authorities worldwide. Your role will involve working closely with various cross-functional stakeholders in BMS to prepare accurate and concise safety information for the development of new treatments and post-marketing safety activities. **Principal Responsibilities:** - Attend meetings related to structured benefit risk assessment (SBRA) to understand approaches and contribute to discussions. - Schedule and facilitate meetings to discuss risk manag...

Role & responsibilities Main Responsibilities: KEY RESPONSIBILITIES 1) To maintain high degree of quality of documents required for submissions to get the approval without deficiency / non-critical deficiency. 2) Timely readiness and submission of documents / dossier for variation / new submissions and renewals in different countries. 3) To follow Global Working Instructions and local SOPs for new submissions, variations and renewals and also support DRA initiatives. 4) Proven expertise in scientific writing and regulatory documentation 5)Strong project management capabilities and ability to work independently 6) Familiarity with global regulatory requirements and submission processes Key Co...

Greeting you from Capco Technology ! About Us Capco, a Wipro company, is a global technology and management consulting firm. Awarded with Consultancy of the year in the British Bank Award and has been ranked Top 100 Best Companies for Women in India 2022 by Avtar & Seramount . With our presence across 32 cities across globe, we support 100+ clients across banking, financial and Energy sectors. We are recognized for our deep transformation execution and delivery. WHY JOIN CAPCO You will work on engaging projects with the largest international and local banks, insurance companies, payment service providers and other key players in the industry. The projects that will transform the financial se...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

At EY, we're all in to shape your future with confidence. We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. Risk Consulting MENA FS Risk and Compliance ICAAP & ILAAP Manager Description EY GDS Risk Consulting is a unique, industry-focused business unit that provides a broad range of integrated services that leverage deep industry experience with strong functional capability and product knowledge. MENA risk consulting practice provides integrated consulting services to financial institutions and other capital markets participants, including commercial banks, investment b...

As an Assistant Manager Regulatory Affairs for EU & UK markets, your role involves driving CMC documentation, regulatory submissions, and lifecycle management to ensure compliance with regional and international guidelines. Your key responsibilities will include: - Conducting comprehensive CMC reviews of technical documentation for regulatory filings in the EU and UK markets. - Performing Gap Analysis and Remediation for Module 3 (CMC) sections to ensure submission readiness and alignment with regulatory standards. - Developing and implementing regulatory strategies, processes, and timelines for the preparation and submission of Marketing Authorization (MA) applications. - Preparing and comp...

As a Senior Medical Writer at ICON, you will be responsible for leading the development and execution of medical writing strategies for clinical trial projects. Your role will involve the following key responsibilities: - Leading the preparation, review, and editing of various clinical study documents such as clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), patient narratives, and regulatory submissions (CTD modules). You will ensure accuracy, clarity, and compliance with regulatory guidelines and industry standards. - Collaborating closely with cross-functional teams including biostatistics and programming, regulatory affairs, and medical affairs. You w...

Job Overview Responsible for assisting with overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process, which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business. Responsible to provide all clients, both internal and external, with the appropriate quality of service ...

Varex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the following: Job Description Keeps abreast of medical device regulatory procedures, medical device safety standards and changes in global regulations. Strong working knowledge of FDA regulations, UK, EU, ISO13485, Brazil, Australia, China, Japan, Canada, and Rest of World Compiles all materials required in submissions, license renewal and annual regist...

Manager – Regulatory Affairs & Advocacy Gurugram – Full time About Absolute : Absolute is a bioscience company founded with the idea of a shared future where both people & planet win together. The company’s vision is to build a thriving future for people and the planet by harnessing the power of nature, science & exponential innovation. Today, Absolute’s Bio division has evolved into a generation-defining bioscience company across Agriculture, Human Health & Sustainable Materials. Operating across 30+ countries, Absolute’s Agtech businesses encompass – Climate Solutions, Soil Health testing, Crop Insurance & Tech driven commodities trade. Absolute’s revolutionary businesses are backed by, Xe...

Role & responsibilities The QA & Regulatory Affairs Manager leads and oversees all regulatory and quality assurance activities within the company, ensuring that all products comply with local and international medical device regulations . The role is responsible for developing and executing regulatory strategies , managing submissions and approvals , and maintaining strong relationships with health authorities, notified bodies, and certification agencies to support product launches and lifecycle management. A core aspect of this position is to build and implement a full Quality Management System (QMS) compliant with ISO 13485:2016 , and to ensure regulatory readiness for global markets inclu...

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary Perform for all the labelling update and maintenance activities with respect t...

Job Title: Associate Director, Patient Safety Scientist Global Career Level: E1 Introduction To Role The Associate Director, Patient Safety Scientist role works collaboratively with the Global Safety Physician (GSP) and Senior Patient Safety Scientist to review safety data and related documents for potential safety issues. This role involves authoring and providing pharmacovigilance input to safety documents and regulatory reports. The Associate Director also leads meetings and presents safety data and analyses. Accountabilities Leads and/or conducts proactive pharmacovigilance and risk management planning for designated products, including preparation of safety aspects of Global Risk Manage...

(2 -4) Years of Work Experience in regulatory. WHO Collaborative countries having knowledge of Regulatory guideline viz ICH, EMEA , PIC.

Job Description Replacement for Manisha Shivpuje 2. To support the activities for Regulatory Submissions as given below: Submission of Annual Reports and supplements. Support for New Product Launch. Submission of Labeling Amendment. Submission of Response to DRL (Discipline Review Letter)/IR (Information Request), Complete Response Amendment Support Work Experience fresher to 1 years.Dossier commpliation experince/Awareness on quality guidlines. Education Graduation in Pharmacy Masters in Chemistry Competencies Customer Centricity Developing Talent Collaboration Strategic Agility Process Excellence Stakeholder Management Innovation & Creativity Result Orientation

As a Quality Compliance Manager at Amgen, you will play a crucial role in providing proactive end-to-end quality support for the development and implementation of a risk-based quality assurance strategy within the General Medicine Therapeutic Area. Your responsibilities will include: - Acting as a GCP Subject Matter Expert to provide independent and objective quality advice for clinical trial activities. - Ensuring quality oversight for all stages of products in clinical development. - Utilizing the Risk Assessment Categorization Tool (RACT) to identify, prioritize, and mitigate risks in trials. - Supporting the establishment of regional expertise to ensure compliance with local regulations....

Job Overview Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business. Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and co...

Summary Of Responsibilities Respond to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc. (Language of communication: French) 24x7 rotational shifts Receive information, record, and report Adverse Drug Reaction in timelines (according to the regulations and to internal WI/SOPs) that may be received over the telephone call, email, fax etc. Execute drug safety data management processes a combination of call intake, call dialogue documentation, peer review, case follow-up. Perform and support different activities as assigned tracking several types of information and metrics, ongoing QC of defined process steps, tr...

Summary Of Responsibilities Respond to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc. (Language of communication: French) 24x7 rotational shifts Receive information, record, and report Adverse Drug Reaction in timelines (according to the regulations and to internal WI/SOPs) that may be received over the telephone call, email, fax etc. Execute drug safety data management processes a combination of call intake, call dialogue documentation, peer review, case follow-up. Perform and support different activities as assigned tracking several types of information and metrics, ongoing QC of defined process steps, tr...

Role & responsibilities To ensure completion of documentation as per requirement for receipt of all license and certificates. Gather relevant data from relevant departments and compile the licensing application in standard format for fresh/ renewal/ test licenses / COPP etc. Maintenance of drug licenses of all CNF locations and manufactures and follow up with them for renewal as and when required. Preparation of documents for tender. Issuing Brand NOCs to supply chain departments for getting license on P to P basis as per the requirement. Proactive, interactions with the concerned personnel's for follow up for FDA pending jobs (Baddi, Daman, LL Locations, TP etc). Maintain records of all lic...

Preparation, Review and Submission of documents related to Product registration with CDSCO and FDCA. Review of the Regulatory applications for Emerging Markets (ROW). Preparation, Review and Submission of applications for Manufacturing License. Preparation, Review and Submission of applications for Registration of GMP Certificates (WHO-GMP, State GMP), COPP, FSC certificate etc. Co-ordination with various departments related to the Regulatory Submissions with respective teams i.e., F&D, QC, Production and QA. Preferred candidate profile

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary Perform for all the labelling update and maintenance activities with respect t...