Team Lead Regulatory Affairs DDReg Pharma

5.0 - 9.0 years

0 Lacs

haryana

On-site

The primary responsibility of this role is to manage Regulatory Affairs in compliance with relevant regulations and guidelines for the organization. As a Regulatory Affairs Manager at DDReg, you will be involved in reviewing clinical, biopharmaceutical, non-clinical, and labelling documentation. Your duties will include preparing and reviewing non-CMC sections, Variations, site transfers, and conducting post-approval gap analysis. Additionally, you will support the regulatory function through document management, electronic submission compilation, and other group management activities as needed. Collaboration with various departments such as Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, and Research and Development will be necessary to ensure regulatory compliance and operational excellence. Your responsibilities will involve providing high-quality reviews of CTD sections for regulatory filings to various regulatory authorities such as EMA, UK MHRA, National Agencies of EU Member states, Canada, Australia, and other markets globally. You will actively contribute to developing and implementing regulatory strategies, processes, and timelines for global approval. Conducting Gap Analysis of Non-CMC sections, authoring and compiling CTDs sections, preparing labelling documentation, managing labelling changes, and ensuring compliance with regulatory guidelines will be key aspects of your role. Furthermore, you will be required to demonstrate expertise in regulatory matters, collaborate with internal and external stakeholders, and provide technical consultation and advice on strategy and industry best practices. To excel in this role, you should possess a Bachelor's or Master's degree in Pharma and have at least 5+ years of relevant experience in the pharmaceutical/CRO industry. Strong project management skills, excellent interpersonal and communication skills, and in-depth knowledge of global regulatory guidelines are essential for success. Proficiency in Microsoft Word, PowerPoint, and Excel, along with the ability to work effectively in a team-oriented environment, are also crucial requirements. The ideal candidate should be adaptable, capable of working under pressure, and able to deliver high-quality results within tight timelines. This position is based in Gurgaon, Haryana, India. Occasionally, you may be required to work across different time zones to fulfill job requirements.,

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Invivo Mice Scientist AVE-Promagne Business Solutions

2.0 - 7.0 years

10 - 11 Lacs

Hyderabad

Work from Office

You get to collaborate on: Work closely with discovery specialists, disease area scientists and in vivo team members. Handling of laboratory animals like rat, mice, Guniea Pig and Rabbits. Dose administration to experimental animals by different routes and small animals surgery (like cannulations, CSF fluid collection) and handling, followed by compound dose preparation, administration to experimental animals. Contributing to the ongoing drug discovery programs by conducting in vivo DMPK studies for NCEs with a good knowledge of in vivo animal models. Data generation, analysis, compilation, report preparation. Regular uploading of the data. Conduct statistically supported data (analysis using win online) and deliver results in a timely manner to enable informed decision-making Understanding systems, processes, and compliance. Prepare, review, and deliver scientific presentations for internal/external use. Participate in cross-functional team activities, add value to research projects through creative ideas. Learn from top-notch drug discovery scientists across the world and opportunity to get trained in people skills. PK-PD studies in rat and mice of NCE.

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Invivo Pharmacokinetic R&D Engineer AVE-Promagne Business Solutions

3.0 - 8.0 years

6 - 16 Lacs

Hyderabad

Work from Office

You Get To Collaborate On Work closely with discovery specialists, disease area scientists and in vivo team members. Handling of laboratory animals like rat, mice, Guniea Pig and Rabbits. Dose administration to experimental animals by different routes and small animals surgery (like cannulations, CSF fluid collection) and handling, followed by compound dose preparation, administration to experimental animals. Contributing to the ongoing drug discovery programs by conducting in vivo DMPK studies for NCEs with a good knowledge of in vivo animal models. Data generation, analysis, compilation, report preparation. Regular uploading of the data. Conduct statistically supported data (analysis using win online) and deliver results in a timely manner to enable informed decision-making Understanding systems, processes, and compliance. Prepare, review, and deliver scientific presentations for internal/external use. Participate in cross-functional team activities, add value to research projects through creative ideas. Learn from top-notch drug discovery scientists across the world and opportunity to get trained in people skills. PK-PD studies in rat and mice of NCE. Who will thrive in this role M.Pharm / M.S in Pharmacology with 3-5 years of research experience in either academic or industrial R&D setting. Deep understanding in pharmacokinetics, physiology along with in vivo disease model development and testing. Prior experience in small animal handling, dosing through different routes of administration, dissections and tissue harvesting, tissue processing Fair understanding about the drug discovery process. Excellent organizational, interpersonal, and problem-solving skills Experience of working with different cross functional teamsExcellent oral and written communication skillsStrong work ethic; scientific curiosity; can-do, will-do attitude. Experience in using electronic lab notebook system. If you don't meet all of the requirements listed here, we still encourage you to apply. No job description is perfect, and we might find an even more suitable opportunity that matches your experience.

Posted 2 months ago

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