Regulatory Operations Specialist

Acino Pharma

Key Responsibilities:

• Acts as a helpdesk for eDMS and RIMS user`s requests and handles user access.
• eDMS and RIMS system administration: related objects, dashboards, system audit reports creation; user testing, maintenance of technical/ non-technical documentation related to changes in the systems.
• Partner with regulatory teams on the creation/revision of records, objects, activities, etc. in the Regulatory Information Management (RIM) system for global and regional portfolio.
• Supports the evaluation of data quality issues through the review/analysis of system generated compliance reports. Participate in data cleansing operations to facilitate appropriate and timely access to data for key systems (eDMS and RIMS).
• Performs data stewardship in line with IDMP standards for the initial marketing authorization applications.
• Responsible for dossiers compilation for initial marketing authorization applications, eCTD dossier conversion and migration of regulatory dossiers to the controlled environment.
• Participates in data and dossiers migration activities for M&A.
• Contributes to the development and implementation of departmental Standard Operating Procedures (SOPs), Working Instructions (WI), user manuals, and data standards.
• Monitors legislation related to data standards and dossiers formats, such as CTD, eCTD, IDMP, eSubmissions, and new trends related to publishing, and databases to ensure compliance of RIMS & eDMS to the requirements from regulatory agencies. Continued oversight of EU SPOR data in RIMS with specific focus on standardize Organizations (OMS) and Substances (SMS) processes and maintenance of Referential (RMS) lists.
• Participates in defined tasks of IT projects related to RIMS & eDMS development and enhancement.
• Responsible for user testing and maintenance of e-learning for RIMS & eDMS, trainer led training.
• Responsible for generation and visualization of system reports.
• The employee will perform other tasks under the direction of the Manager within the agreed type of work.
• Adhere to ACINO legacy internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at pharmacovigilance training.
• Forward all of received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.
• All training to be completed as per training plan.

Key Skills:

• Must possess knowledge in data entry and data management in GxP environment and CTD/eCTD dossier structure. Must possess basic knowledge in Regulatory Affairs.
• Must understand ISO IDMP (Identification of Medicinal Products) data standards.
• Must have ability to multi-task and manage multiple projects and deadlines. Ability to understand complex IT tools and software. Ability to read and interpret complex business and/or technical documents. Ability to work in an international, cross functional team environment. Must possess excellent attention to detail and propensity to learn. Must be proficient in Microsoft Word, Excel and other Microsoft Office Applications.
• Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with managers or directors and communicate ambiguous concepts. Ability to present to groups across the organization.

Qualification & Experience:

• Minimum of a bachelor s degree in business or sciences (or equivalent).
• 1-5 years experience in Regulatory Operations or Regulatory Affairs. Other pharmaceutical experience (e.g. Research & Development, Quality Assurance/Compliance) will be considered.
• Hands-on experience with Regulatory Information Management and Submission Management Systems.
• Experience in working with EMA (European Medicinal Agency) SPOR (Substances, Products, Organizations, References) Management Services is preferred.
• Proficiency in speaking, comprehending, reading and writing English is required.