The Team Lead will manage the Regulatory Information Management & Systems Technical Services team. Responsible to support an efficient and globally harmonized service model and ensure timely, high quality and compliance deliverables according to given timelines.
The service model includes but is not limited to submission resource planning, submission publishing, document processing and data entry.
Your responsibilities :
Your responsibilities include, but are not limited to :
Take leadership and ensure that the Regulatory submission publishing, document processing and data entry function deliverables are provided in high quality, in compliance with Health Authority requirements and according to given timelines.
Act as the main contact during the submission preparation and execution phase of product development and initial submission projects.
Receive and resolve or mitigate is-sues. Implement actions to prevent that issues happen again Act as a service provider 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 re-ports on a regular basis.
Ensure timely updates of submission data in 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 re-ports and ensure high quality performance management across Regulatory IM&S In cooperation with IM&S LT and together with your team strive for excellence and sup-port initiatives like knowledge transfer between sites and sub-functions to develop and grow together to a globally acting support function
What you’ll bring to the role :
University or College Degree in any field or life science with relevant industry experience or comparable degree Good communication in English (oral and written).
At a minimum 10 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 the Regulatory submission publishing, area.
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 and to coordinate interactions with internal and external partners.
Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic.
1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking : how can we continue to pioneer access in an ever-more digital and global world?
The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.
Join us, and help reimagine access to medicine.