Head Global 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 245646BR


Stellenbeschreibung

• Collaborate closely with the Regulatory and Regulatory Information Management and Systems (IM&S) leadership team to facilitate a highly performing IM&S organization which supports Global Regulatory Affairs with the optimum efficiency
• Leads the Regulatory Submission Publishing, Data- Management, Reporting, Document Processing and Structured Data Submission function and ensure high quality and Health Authority compliant and timely deliverables
• Interacts with various Regulatory and Development functions during the submission preparation phase of an initial marketing authorization application.
• In cooperation with IM&S Business Process Excellence ensure a strategy and support building and implementing a tool to plan submission publishing activities globally
• In the area of competence offer strategic and operational expertise to project teams to ensure the timely, and compliant preparation and execution of submissions to Health Authorities
• Ensure business support for high quality, timely and efficient processing of regulatory, submission-relevant documents like M1, eApplication Form, COPPs, GMP Certificates
• Define the functional KPIs and targets according to the overall Regulatory objectives. Determine appropriate actions when targets are not on track and follow up on action plan
• Select, recruit, develop, manage, coach, coordinate and appraise the performance of direct/indirect reports and ensure high quality performance management across the function
• Be ahead of new health authority requirements and lead the function through the implementation of these requirements, e.g. in case of eCTD transition projects for additional countries or regions
• May communicate with Health Authorities during the submission procedure and act as the contact for technical questions such as eCTD lifecycle, submission format and submission technical validation



Research & Development


Mindestanforderungen

• University or College Degree in any field or life science with relevant industry experience
• Broad experience (approx. 10+ years) in the Pharmaceutical area, specifically in Regulatory Operations
• At least 5 years line management and proven global team leadership experience
• Strong organizational, planning, resource and international project management skills
• Extensive knowledge in the field of Regulatory guidelines for electronic submission publishing, structured data submissions like XEVMPD and SPOR / IDMP, document management
• 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
• Strong interpersonal and communication skills, and ability to operate effectively in an international environment
• Superior people management skills with demonstrated positive leadership, innovative and collaborative behaviors
• 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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