TIEFENBACHER LABORATORIES hiring for Executive / Sr.Executive/ Asst.Manager in Regulatory Affairs department
We are excited to announce a fantastic career opportunity for an Executive, Sr. Executive & Asst. Manager in Regulatory Affairs-RIMS & Bioanalytical- QA/ QC, Join an organization renowned for its high repute and enjoy a workplace that prioritizes a healthy work-life balance.
WE ARE HIRING join our team
Open Position:
Executive / Sr.Executive/ Asst.Manager
Department:
Regulatory Affairs-RIMS
Experience: 4 to 8 Years
Qualification:
B.Pharmacy/ M.Pharmacy/ MSc/ Any relevant pharma
Job Description:
- Responsible contact person in the area of Regulatory Affairs for the RIM
- Direct supervision over the RIM activities, working with the Vendor and other stakeholders directly involved and, with colleagues responsible for other systems interfacing with the RIM
- Act as an Industry User Administrator in the EMA Account Management Portal for User Account Management and User Management for PLM (eAF) and in the future for ePI and various e-projects in the pipeline from EMA under the PLM/PMS umbrella
- Responsibility for the support and data management of our EVMPD data as well as the implementation of IDMP in the company including stakeholder engagement (regulatory authorities, industry working groups, and technology vendors) and active participation in relevant forums and EMA webinars
- Regular monitoring and assessment of compliance with IDMP requirements to ensure ongoing adherence to IDMP standards
- Support of the department in all “electronic” issues related to regulatory affairs and pharmacovigilance
- Training and Education for RIMS User involving conduction of workshops, creation of training materials, and information management system training sessions.
Location: Hyderabad
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