Regulatory Affairs CMC Manager / Specialist (limited) - Geneva
We are looking for a Regulatory Affairs CMC Specialist for our OM Pharma site in Geneva to support CMC activities for products of the portfolio. You will report to the Regulatory Center of Excellence Team Lead and your responsibilities will include, but not be limited to:
- Liaise with EU/CH/US and International regions as well as Regulatory Operations groups to ensure appropriate planning and timely preparation of CMC-related submissions
- Collect CMC documentation for life cycle management activities, e.g. renewals and variations
- Author high-quality CMC documents
- Manage answers to questions from Health Authorities related to CMC topics
- Evaluate change controls and coordinate assessment of worldwide impact of proposed manufacturing changes, ensure the regulatory implications have been considered and provide regulatory strategy for optimal and timely implementation of these changes
- Populate and maintain regulatory documentation databases
Furthermore, your profile meets the following criteria:
- Scientific background (University degree in chemistry, biology or pharmacy)
- From 2 to 5 years of work experience in Regulatory Affairs CMC, expertise in Biologics is an asset
- Good knowledge and appropriate interpretation of guidelines, directives etc.
- Proven experience and knowledge in document management system
- Accuracy, self-assertion and creative work approach
- Strong adaptability and very good communication skills
- Fluent in English and French (good command of both, written and spoken language is mandatory)
We are looking for a customer and service-oriented person who brings experience in working with a wide variety of stakeholders across diverse teams both internally and with external partner companies.
You describe yourself as a solution-oriented, autonomous and flexible person who enjoys working in a dynamic environment. You are an open minded character with a strong team spirit and have the the ability to work under stress and to deal with tight deadlines.