Search Results: 184 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...
...affecting optimal and timely submission. Independently manage US regulatory compliance activities, including timely review and updates to... ...user fee registration requests. Independently manage and execute drug shipment ticket review process (US)
• In addition to regulatory...
...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...
About the role
Your responsibilities will include, but are not limited to:
• Lead and manage teams in the field of synthetic API development in order to support-development of synthetic strategies to enable fast and reliable deliveries of APIs for early phase development...
...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...
...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...
...is responsible to design and execute data management 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...
...! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians... ...from Statistics, Legal, Regulatory Affairs, Data Privacy, Data Management and Clinical... ...industry and broad understanding of the drug development process.
• Solid knowledge...
...inputs into responses to inquiries from regulatory authorities or health care professionals... ...colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information,... ...graduation.
• At least 4 years in drug development in a major pharmaceutical company...
...development implications of pre-clinical findings, drug formulation information, regulations and... ..., and to use in discussions with regulatory authorities as necessary (e.g. Scientific... ...Global Portfolio Management; Regulatory Affairs); BD&L, Global Portfolio Management, Commercial...
...messages, language and grammar are accurate, regulatory/safety/legal aspects are considered.
•... ...Industry (or related Medical Affairs role).
• Knowledge and application of good... ...industry (regulatory, PV, legal, commercial, drug development, etc.)
• Strong cross-functional...
...compliance (considering internal and external/regulatory requirements).
• Exhibit leadership and accountability... ...healthcare consulting setting, preferably in drug safety (i.e., Pharmacovigilance), clinical research, or regulatory affairs (incl. appropriate business case development)...
...Manages multiple and simultaneous global regulatory submission projects in
eCTD and non-eCTD... ...• 3-5 years of Regulatory Affairs or Regulatory submission related experience... ...publishing activities.
• Familiar with the drug development process
• Effective interpersonal...
...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...
...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...
...multidisciplinary cross functional Clinical Trial Team (CTT) (medical writing, statistics, data management, monitoring partner, drug supply, regulatory, safety etc.) or support the Sr. CPM (where applicable) in the effective planning, regular re-evaluation and implementation...
...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
...Able to work on and collaborate seamlessly with a multidisciplinary team to achieve team objectives.
•Good understanding of drug development, regulatory requirements, ICH and HA guidelines
Role Requirements
Essential Requirements:
•Education: MS/ MSc (in Statistics or...
