At ProClinical, we are seeking an talented individual to fill the role of Associate Director - RIM, based in San Francisco, CA.
- Lead Regulatory Information Management (RIM) and oversee activities related to RIM resources, budget, management of assigned activities, analysis of submission and registration information, and metrics reporting.
- Support regulatory information management activities focusing on key systems and processes.
- Manage regulatory information in the authoritative system for submissions, approvals and associated product data.
- Ensure data is available in a complete, accurate, and timely manner.
- Monitor data quality in systems from planning of regulatory activities through Health authority interaction and to country/ regional implementation.
- Enable data-centric submissions and function as a super-user and RIM expert on all system-supported processes and data requirements.
- Responsible for maintenance and development of SOPs, Work Instructions, etc. related to Regulatory Information Management.
- Identify and initiate on-going continuous process improvement opportunities with stakeholders responsible for RIM data consumption.
- Educate stakeholders regarding the process and data requirements needed to successfully maintain and capitalize on a RIM system.
- Define, monitor, interpret and convey key performance indicators/metrics for critical Regulatory Affairs processes and output.
- Support the initiation and deployment of forecasting, budgeting and maintenance of health authority fees using reporting systems to ensure compliance with International requirements.
- Build and maintain relationships with relevant staff in and outside of the department.
- Monitor emerging health authority regulations and programs impacting RIM and other designated RA systems.
- Interact with industry groups to identify regulatory trends and policy that could impact current systems and processes and develop strategies to ensure compliance with new requirements.
- Support the initiation and deployment of forecasting, collection and maintenance of health authority fees using reporting systems to ensure compliance with domestic and International requirements.
- Implement, maintain and interpret key performance indicators/metrics for critical Regulatory Affairs processes.
Skills And Qualifications
- BA/BS in a related field and/or equivalent experience.
- Experience of Regulatory Information Management systems
- Understanding of emerging regulations such as XEVMPD, IDMP and UDI
- Knowledge and understanding of regional regulations and guidance and ICH guidelines pertaining to Regulatory Affairs and/or Regulatory Operations including IND, NDA, MAA, CTA etc.
- Familiarity with European Procedures (centralized, decentralized and mutual recognition).
- Some knowledge and experience of all submission types.
- Interpret and summarize information from multiple sources including regulations, health authority guidance's, and internal documents.
- Ability to multitask and prioritize under moderate workload with some supervision.
- Proficiency in Microsoft Office suite.
- Proficiency in document management systems.
- Sense of personal responsibility and accountability.
- Understanding of drug development processes.
- Excellent verbal and written communication skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Tudor Carr at (+1) 617-545-5919 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
ProClinical is advertising a vacancy for a Regulatory Executive Senior position
£0.00 - £100000.00 per annum
ProClinical is partnering with an international biopharmaceutical company to advertise a vacancy for a Director, Regulatory Affairs position
ProClinical is advertising a vacancy for a Regulatory Affairs Lead, EMEA
€0.00 - €450 per day
Wavre, Walloon Brabant
ProClinical is currently recruiting for an RA Compliance Expert Transition Team position