Regulatory Affairs RIMS Officer (M/F)

Job description

Nestlé Skin Health is a global leader in improving the quality of life by delivering innovative medical solutions for the health of skin, hair and nails throughout people's lives. Nestle Skin Health aims to meet the needs of healthcare professionals and consumers through constant innovation in technology and products to protect and improve the health of the skin and treat skin diseases.

Nestlé Skin Health is a subsidiary of Nestlé.

For our Global SIG Rx organisation, we are currently looking for:

Regulatory Affairs RIMS Officer (M/F)

Based in the Lausanne region of Switzerland, in an innovative and dynamic environment, you will be attached to the Head of Regulatory Affairs Document Submission and will:

Manage Regulatory Information Management System (RIMS) for all NSH products (all SIGs). Manage Rx SIG operational needs and support the coordinators for A&C and Consumer SIGs. Coordinate with IT support and/or service providers as needed.

Activities and responsibilities :

Main responsibilities:

· Manage RIMS application in compliance with regulatory requirements.
· Interface with Coordinators from Consumer and A&C SIGs to support function for all products.
· Propose/animate/manage evolution of application to improve efficiency and to ensure continued regulatory compliance.
· Manage training support for new users.
· Monitor data entry compliance. Propose/manage corrective action plans, if necessary.

Quality :

· Write SOPs, forms, etc. to describe the day-to-day operations of function.
· Propose/implement process improvements

Regulatory :

· Monitor internal and professional communications concerning relevent regulations (ICH, FDA, EMA …)
· Propose/particpate in steps required to maintain regulatory compliance

Expected qualifications :

· BSc, MSc in scientific, IT or administrative discipline or equivalent experience
· 5 years experience Pharmaceutical Industry
· 2 years in similar role
· Experience of managing service providers.
· Fluent in English

Location: Lausanne Region, Switzerland.

Date: As of Q2 2018