Celgene Associate Manager Regulatory Affairs in ZURICH, Switzerland

Description

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

Qualifications

PREREQUISITES

The educational requirements are preferably

  • Pharmacist or Life Science degree at an academic level

  • Experience in pharmaceutical industry with

2-5 years regulatory affairs experience in Switzerland

interacting with Swissmedic.

  • Working knowledge of the local drug regulations,

clinical trials regulations and relevant ICH guidelines.

  • Experience in working with eCTD dossiers.

  • Strong negotiation skills and project management competency.

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 written and verbal skills in German and English

• Good computer skills to include: MS Office incl. MS Project

• Strong identification with Celgene’s values

Associate Manager Regulatory Affairs

Location: ZURICH, Zurich, CH

Job ID: 17001679