Team Leader Regulatory IM&S Technical Services (m/f)

SANDOZ
Division SANDOZ
Geschäftseinheit Product Dev SZ
Standort Holzkirchen (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 251309BR


Stellenbeschreibung

• Take leadership and ensure that the Regulatory Submission Publishing, Data- Management, Reporting, Document Processing and Structured Data Submission function deliverables are provided in high quality, in compliance with Health Authority requirements and according to given timelines
• Act as the main contact for technical aspects during the submission preparation and execution phase of development and initial submission projects. Receive and resolve or mitigate issues. Implement actions to prevent that issues happen again
• Ensure timely updates of registration and submission data into the Regulatory Information Management databases and verify that the data is kept compliant
• Ensure timely and efficient processing of regulatory, submission-relevant documents like M1, eApplication Form, COPPs, GMP Certificates
• Collaborate closely with the RA IM&S leadership team to facilitate a highly performing IM&S organization which supports global Regulatory Affairs with the optimum efficiency.
• Monitor the functional KPIs and targets. Escalate deviations and support appropriate mitigation actions when targets are not on track and follow up on action plan.
• Select, recruit, develop, manage, coach, coordinate and appraise the performance of the reports and ensure high quality performance management across Regulatory IM&S
• Act as a service provider and strategy partner for customers in Regulatory and stakeholders outside of Regulatory. Build up a communication network with the stakeholder community
• Inform IM&S LT about the progress of ongoing activities and provide performance reports on a regular basis
• In cooperation with IM&S LT and together with your teams strive for excellence and support initiatives like knowledge transfer between sites and sub-functions to develop and grow together to a globally acting support function



Research & Development


Mindestanforderungen

• University or College Degree in any field or life science with relevant industry experience or comparable degree
• At a minimum 5 years’ experience in the Pharmaceutical area, specifically in Regulatory Operations
• Proven experience in line management and /or project management leadership
• Strong organizational, planning, resource and international project management skills
• Proven experience in either one of the following areas: Regulatory submission publishing, electronic document management, structured data submissions, regulatory information management
• Knowledge of Regulatory guidelines for the areas mentioned above
• Organizational awareness, including significant experience working cross-functionally and in global teams.
• Ability to work independently, under pressure, demonstrating initiative and flexibility
• High level understanding of Regulatory quality, standards and policies.
• Attention to detail and quality focused
• Ability to mentor, coach associates
• Team-minded
• Good communication in English (oral and written).

We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples’ lives. We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.
Novartis stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.



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