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GRLI-0, Senior Associate License Management
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.
Archive and store regulatory communications (internal or external)
Perform data entries and updates (e.g. RIMS)
Archive in eDMS/ local document repository Execute initiatives to ensure regulatory compliance, as required
Align with other functions (e.g. GPS) for compliance report requirements
Monitor and track submissions and approvals
Prepare and distribute status reports as required
To provide any other ad-hoc support to activities executed at REC, envisaging that:-Relevant training has been successfully completed upfront-The necessary regulatory, system, product or process knowledge has been provided-Skills and competencies required for the ad-hoc tasks completion are in line with the agreed REC skill setSuch additional allocation may be an element of individual development plans or a contribution to the business continuity of the organisation
Job specific Competencies & Skills
Management and Planning: Ability to execute assigned tasks with support from team lead/mentor. Adherence to agreed timelines and proactive communication of any risk for the same. Provide high quality deliverables as per standards. Fully trained in related systems and databases (APT, Trackers, RIMS, EDMS). Understands the contribution of own work to the organizations value chain and demonstrates creation of customer value. Shall anticipate opportunities and invest in learning about technologies in own area.
Communication and Collaboration: Excellent written and spoken English language. Demonstrates proficiency in day-to-day business communication. Demonstrates proficiency in compiling and delivering presentations to a target group of people within the own area of specialization/ project environment. Consistently takes an active role in networking activities within own area of specialization/ project environment. Focuses on facts and quality of work rather than origin of ideas (does not follow cultural stereotypes). Recognizes other’s point of view and makes sure that everyone is listened to and understood. Pursues active networking across disciplines/ areas, projects.
Systems and Applications: User has advanced skills with all standard MS office and business applications (word, excel, power point, MS project, outlook, skype, SharePoint). User has contributor level of experience with RIMS and EDMS RA application. Upon completion of a dedicated training, user can perform routine/ standard activities within the RA systems with no supervision required. The output of the user will usually undergo standard QC/spot check procedure.
Regulatory Expertise: Good knowledge about Regulatory Affairs and specifically post approval changes, regulatory dossier types and main regulatory procedures globally. Understanding of supportive documents necessary for the registration and LCM of pharmaceutical products (CPPs, GMP Certificates, MLs, AtO’s, AFs, CLs, PoA’s etc.) as well as legalization framework. Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request.
Pharma business acumen: Have a good understanding on how business operates and makes smart decisions trying to see the big picture without losing view of the details.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!