Teamleader (f/m/d) Regulatory Information Management Systems (RIMS)

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Date: 30-Jun-2022

Location: Bad Vilbel, HE, DE, 61118

Company: STADA Arzneimittel AG

At STADA we pursue our purpose “Caring for people‘s health as a trusted partner” worldwide. Originally founded by pharmacists, we are a leading manufacturer of high-quality pharmaceuticals. More than 12,300 employees around the globe live our values Integrity, Entrepreneurship, Agility and One STADA to achieve ambitious goals and shape the successful future of STADA.

 

Our global Headquarter, STADA Arzneimittel AG, is located in Bad Vilbel near Frankfurt am Main. To strengthen our Regulatory Operations team we are looking for a


Teamleader (f/m/d) Regulatory Information Management Systems (RIMS) 

[[cust_cityPosting]] | Deutschland (DE) | Full-time | [[cust_limitationNew]] 

 

Your responsibilities:

 

  • Functional lead of a team in Regulatory Operations
  • Be a business analyst and subject matter expert to identify and document RIM related user requirements and use cases in collaboration with cross-functional stakeholders
  • Develop procedure documents or best practices for RIM, implementing and managing RIM governance
  • Be a business partner to provide application support for future and existing RIM systems
  • Be part and responsible of system validation activities by developing and executing test scripts for RIM systems and liaise with RIM system and service vendors
  • Collaborate with GIS and key business stakeholders
  • Be responsible for RIM technology solution identification, insights into new regulations, requirements, guidance and specifications relevant to RIM technology
  • Monitor, analyze and track new functionality of new RIM releases and implement in collaboration with GIS, vendors and cross-functional key business stakeholders
  • Assist in audit and inspection activities including retrieval of Regulatory Information
  • Strengthen our team with developing and execution of RIM-specific training on how to effectively access Regulatory information
  • Support and collaborate with the central master data and Data Science & Analytics groups with implementing data standards and reporting 
     

Your qualification:

 

  • University degree in a scientific discipline or equivalent
  • In-depth relevant experience and proven knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (e.g., EMA (must), FDA (desired), ICH, eCTD, IDMP, UDI)
  • Knowledge of pharmaceutical drug and device development, maintenance processes (Generics) and regulatory terminology
  • Advanced proficiency in Regulatory Affairs/Operations/information & Computer System Validations (Eudralex Vol 4, Annex 11&15 is necessary and 21 CFR Part and Annex 11 Regulations is preferred)
  • Knowledge of Software Development Life Cycle methodologies preferred
  • Experience of technical and SOP writing as well as proven knowledge and practical experience in European procedures (e.g. MRP/DCP, NP, CP)
  • Proven knowledge and practical experience with RIM technologies and a strong knowledge of categorization and classifying regulatory information
  • Expert knowledge of relationships between key components of Regulatory Information as well as a proven experience managing RIMS projects (e.g., RIM, EDMS, tracking & publishing systems)
  • Ability to lead, manage, and contribute to multiple ongoing projects simultaneously and contribute to improvement initiatives
  • Expereinced in functional team leadership
  • Experiences of xEVMPD, SPOR, TOM, CESP and related processes and guidelines
  • Fluent in English, German language is a plus
  • Ability to work in an agile environment as an excellent communication, conceptual and analytical skills as well as being a collaborative team player

 

Are you looking for new challenges where you can make a difference for people’s health? We are looking for candidates with expert knowledge and an entrepreneurial spirit that enjoy working collaboratively in a global team. We would be pleased get to know you. Please use our online job portal to submit your application: jobs.stada.com