Celgene Associate Manager Regulatory Affairs in Zurich, Switzerland
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Responsibilities include, but are not limited to:
Responsible for the maintenance of current MAA’s for the assigned products
acts as main contact towards Swiss HA for the assigned products
meeting time schedules and demands of authorities for updates, variations, periodic regulatory reports (e.g. PSURs), renewal of valid registrations
Defines the regulatory strategy for Celgene products in Switzerland with the support of the Local Regulatory Affairs lead
develops submission strategies for NAS application and major variations
monitors changes in guidelines and flags chances and risks to the team
Close collaboration with the European Regulatory Head Quarter and Reg. Operation
defines content and timelines for submission
gives guidance to global project teams on Swiss regulations
assures proper timeline management according to CH requirements
Represents Regulatory Affairs within the local, interdisciplinary Disease Teams for the assigned portfolio
drives strategic development from a regulatory affairs perspective
Builds strong knowledge and network in the relevant disease area’s
Engages in inter-department projects
Supports and collaborates with local RMP responsible person
Supports audits and inspections
Skills / Knowledge Required:
Excellent project planning, administrative and organizational skills; attention to detail and timelines
Ability to prioritize tasks, to work on multiple tasks in parallel and under time pressure
Flexible and adaptable to changing project priorities and work assignments
Strong negotiation skills.
Strong written and verbal skills in German and English
Good computer skills to include: MS Office incl. MS Project
Strong identification with Celgene’s values
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE