Celgene Associate Manager Regulatory Affairs in Zurich, Switzerland

Description

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

  • Other activities

  • 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