Search Results: 152 vacancies
...About the role
Role Title: IT Business Analyst - Regulatory Affairs
Location: Hyderabad
About the Role:
The job purpose is to act as a consultant and advisor providing guidance to improve complex global business processes, products, and services. We are looking...
About the Role
Role Title: Sr. Spec. DDIT Dev. Technical Design (Regulatory Affairs)
Location: Hyderabad
Role Purpose:
The purpose of the role is to
• Lead the design and managing deliverables of RA Publishing business critical applications as well as provide support...
...Basic Purpose of Job: The Regulatory Reporting Assurance (RRA) department is a management assurance team in the Controller’s Organization within Corporate Finance. The Regulatory Assurance team is responsible for the independent verification of controls and processes over...
...related activities
• Proactively identify issues, gaps, and trade-offs affecting optimal and timely submission. Independently manage US regulatory compliance activities, including timely review and updates to product specific information as provided by program team...
...About the role
Position Title: Senior Regulatory Writer
About the role: Senior Regulatory Writer
Location – Hyderabad #LI Hybrid
That is the approximate number of individual regulatory documents the dynamic team at Regulatory Writing and Submissions (RWS) planned...
...About the role
Your responsibilities include but not are limited to:
• Regulatory Strategy -Responsible for implementing regulatory strategy and managing operational activities for assigned regions.Provides input into global regulatory strategy and contributes to Regulatory...
...solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and...
...management, pharmaceutical development.
In-depth knowledge of regulatory compliance, supply chain management, and financial modelling... ...API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China...
...for contributing to the planning, coordination, development and timely delivery of high quality Clinical submission documents to Regulatory Affairs (RA) for
1) New Drug Applications (NDA), Biologic Licensing Applications (BLA), Marketing Authorization Applications (MAA) and...
...suppliers, vendors and customers.
Perform cost benefit analysis and finalize annualized savings for given project.
Work with Regulatory Affairs team members to acquire the required product approvals.
Perform VAVE study and identify cost out opportunities which are...
Remote job
...strategy across Drug Development line functions i.e. Clinical Operations, Clinical Data Standards, Technical Research & Development, Regulatory Affairs and Patient Safety. Function also collaborates with cross domains such as Technical Operations, Research, Finance, Procurement...
...growing Industry expertise! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers... ...collaborate with colleagues from Statistics, Legal, Regulatory Affairs, Data Privacy, Data Management and Clinical Development and have...
...detection tools.
• Provides inputs into responses to inquiries from regulatory authorities or health care professionals on safety issues.... ...safety tasks with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data...
...product development optimization, and to use in discussions with regulatory authorities as necessary (e.g. Scientific Advice, briefing book,... ...Development (i.e. Global Portfolio Management; Regulatory Affairs); BD&L, Global Portfolio Management, Commercial Operations (i.e....
...adhere to topic/key messages, language and grammar are accurate, regulatory/safety/legal aspects are considered.
• Provide input into MI... ...Communications in the Pharmaceutical Industry (or related Medical Affairs role).
• Knowledge and application of good practices in...
.... quality) and/or compliance (considering internal and external/regulatory requirements).
• Exhibit leadership and accountability for initiatives... ...(i.e., Pharmacovigilance), clinical research, or regulatory affairs (incl. appropriate business case development)
• Solid knowledge...
...Artworks for Pre-Exhibit, Exhibit.
Coordinate with internal departments like Purchase, Analytical RD, Production, Quality Control, Regulatory Affairs, Quality Assurance, Project Management, Engineering etc, for seamless Technology Transfer.
Coordinate with external customers...
...are not limited to:
• Manages multiple and simultaneous global regulatory submission projects in
eCTD and non-eCTD format [e.g., NDA/... ...communities we serve.
Role Requirements
• 3-5 years of Regulatory Affairs or Regulatory submission related experience. Experience with...
...products, working with cross functional team, site team and corporate regulatory team to ensure preparation of quality global regulatory strategy... ...10 Years in leading independently or a team in the Regulatory Affairs function in a reputed pharmaceutical organization with major...
...Groupe cimentier français présent dans 12 pays, Vicat emploie près de 9 900 collaboratrices et collaborateurs et réalise un chiffre d’affaires consolidé de près de 4 milliards d’euros, dont 65 % à l’international.
Dans la lignée de Louis Vicat, inventeur du ciment artificiel...
