Regulatory Information Manager at AstraZeneca
Modis Life Science is looking for a Regulatory Information Manager for a consulting assignment at AstraZeneca in Gothenburg. The assignment will start in beginning of February and initially run for the rest of 2021. Send your application ASAP, no later than January 14th.
Global Regulatory Operations (GRO) manages several parts of Regulatory Information Management (RIM) within AstraZeneca. GRO has the expertise and provide the tools and services to be able to meet:
• The ever-increasing complexity of regulations and product portfolios
- Growing demand for data due to increased public and regulatory scrutiny
- Global collaboration and standardization of formats and processes across the markets
- Increased use of partners and outsourcing
The Manager, Regulatory Information is primarily responsible for supporting the management, collection, coding and analysis of AstraZeneca regulatory information, the Global Product Registration List and regulatory data standards such as XEVMPD and IDMP.
- Manages the collection, coding and analyses of regulatory information for assigned products in accordance with regulatory data standards, quality control and quality improvement methodologies.
- Compiles and delivers XEVMPD or other regulatory information-based submissions to health authorities.
- Develops self in topic areas critical to successful delivery of the RI remit. Particularly, technical skills (XEVMPD, IDMP), knowledge of international regulations and skills (communication, project management).
- Engages with partners, affiliates, subsidiaries or other stakeholders to collect regulatory information and to ensure compliance with procedures and standards.
- Monitors the environment for changes in legislation related to regulatory information.
- Reviews and evaluates regulations, guidelines and technical specifications related to regulatory information processes and regulatory information data standards.
- Identifies opportunities for continuous improvement.
- Prepares business reports or alerts in response to business or health authority request.
- Ensures collection and coding of regulatory information is done in compliance with regulatory and pharmacovigilance legislation, regulatory processes and regulatory data standards.
- University degree in the life sciences or IT
- Experience in pharmaceutical/medical industry
- Knowledge of pharmaceutical drug development process
- Strong analytical and critical thinking ability
- Good understanding of current regulatory legislation, guidelines and trends relating to regulatory information (process, tools, standards)
- Able to manage productivity responsibilities
Preferred experience and key factors
- Good problem and conflict resolution skills
- Ability to set and manage priorities, performance targets and project initiatives
- Ability to innovate best practices with business process analysis and design
- Ability to thrive in a rapid paced environment
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