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Team Lead CH RA LCM&E Nutritionals & Digestive Health

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Team Lead CH RA LCM&E Nutritionals & Digestive Health

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change

 

Team Lead CH RA LCM&E Nutritionals & Digestive Health

 

Position purpose:

  • RA Responsibility for the post approval lifecycle management and expansion (LCM&E) activities for the combined Bayer marketed Product Portfolio of Nutritionals, Digestive Health
  • Responsible for quality and timely new and LCM submission and approval in all countries after hand over from the Strategy team as well as ensuring that all registration data are entered into the proper data management systems for covered activities
  • Responsible for ensuring that, product dossiers are properly prepared, maintained, and accessible
  • Overall responsibility for creation and implementation of appropriate regulatory strategies to Health Authorities for the assigned product portfolio in close cooperation with the respective technical (Operations, QA) and global, regional and local Regulatory Affairs (RA) functions, to ensure timely submission and first cycle approval for the products under the Therapeutic Area of responsibility

Major tasks and responsibilities:

  • Line Management / Mentoring for assigned group of Managers, Senior Managers, and Specialists and responsibility for close alignment of LCM activities across the TA-groups
  • Proposes and implements standards concerning CMC, maintenance and life-cycle development in close co-operation with global, regional, and local RA functions
  • Responsibility for achieving assigned global regulatory affairs project objectives for assigned products and product portfolio
  • Ensure compliance of assigned Products and LCM regulatory documentation for the products
  • Ensures and manages the preparation of registration dossiers related to assigned products and proactively identifies and tracks regulatory activities and /or issues and risks and brings these to the attention of RA CH management as necessary

Qualifications:

  • A graduate degree in the life sciences (Ph.D., M.D., PharmD., or MS) or equivalent combination of education and experience
  • Experience to include Ph.D., M.D., or PharmD with a minimum of 8 years of Regulatory experience; or MS with a minimum of 10 years of Regulatory experience, or a Bachelor's degree with at least 14 years' of regulatory experience
  • Strong management and leadership skills, as incumbent has to lead and oversee a group of managers as well as to lead multidisciplinary teams. Demonstrated cross-functional communication, interpersonal, influence, and negotiation skills
  • Deep understanding of Regulatory Business Tasks, preferably from a regional/country perspective
  • Ability to focus on multiple issues at one time, and to organize and direct diverse activities in a changing environment often under time pressure
  • Ability to work within a global team framework and a multi- cultural environment. As jobholder has to work directly with different hierarchical levels within BCC, ability to establish relations
  • Excellent oral and written communication skills

 

Location:

 

Division:

Consumer Health

 

Reference Code:

48987

Zrich, CH-ZH / Basel / Zürich / Basel, CH-BS

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