Regulatory Affairs Specialist

Harvey Nash is looking for a Regulatory Affairs Specialist for a 4 month project in Switzerland.

The role is for a candidate to coordinate and submit marketing authorization applications and variations to Swiss medic, and to create and revise product labeling; in general to support regulatory activities.

You are responsible for

. Coordinating and submitting Marketing Authorization, license renewal, Product transfers and variation applications to Swissmedic. Collaborate with the Regulatory Affairs team
. Generating and submitting Periodic Safety Update Reports (PSURs/PBRERs) to Swissmedic
. Creating and revising (safety) labeling material/product information of medicinal products in collaboration with Marketing, Corporate, and the RA team
. Coordinating, preparing and submitting Clinical Trial Applications (including notification of changes) to Swissmedic and Ethics Committees
. Maintaining project/variation tracking lists and/or tools, and generate reports of submission activities
. Maintaining oversight and accuracy of registered information of each medicinal product; keeping public database of SPC/PI and internal product lists up-to-date with registered product/labeling information
. Providing responses to medical/safety/quality requests from various stakeholders; interrelating with respective Business Units and Medical Information
. Reviewing and approving promotional material, according to national and Corporate requirements as well as to approved product information
. Establishing and revising documents of Regulatory Affairs processes in the Quality Management System, and conduct local training
. Complying with national regulations and guidelines, legal, regulatory, quality (eg, ISO, GxP) requirements and company policies; ensure high ethical conduct

Requirements

. Minimum required: BS degree in pharmacy, medicine, biology, biochemistry, chemistry, or related disciplines; desirable: Master's degree in pharmacy, medicine, biology, biochemistry, chemistry, or related disciplines
. Fluent in German and English both spoken and written is a requirement; solid in French/Italian both spoken and written is a plus
. 2 years of experience in Regulatory Affairs and/or Quality Assurance in a regulated industry (pharma or medical devices) or health care
. Previous operational experience in surgical/medical devices and medicinal products
. Solid experience in submissions to health authorities, preferably Swissmedic
. Knowledge of GxP, ISO 13485, MDD (as applicable) and local quality regulatory requirements
. Solid experience leading people and cross-functional teams; project management
. Computer literacy with standard software platforms
. Marketing authorization applications, clinical trial applications, complaints handling

Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred) to (see below) For further details feel free to call me. I am looking forward to receiving your application.