Location: Switzerland - Meyrin/Geneva
Function: Regulatory Affairs
Company: OM Pharma
We are looking for a Regulatory Affairs CMC Manager for our OM Pharma site in Geneva to coordinate CMC activities for products under responsibility. You will report to the Head of Regulatory Affairs Infectious Diseases and your responsibilities will include, but not be limited to:
- Define and drive CMC regulatory strategy for ID/OTX projects (marketed products), conduct risk assessments and set-up mitigation plans
- Identify required content to ensure compliance with regulatory standards and review CMC documents from technical departments
- Author high-quality CMC documents in the frame of renewals, variations and life cycle management activities
- Liaise with Therapeutic Areas, International, Submission and Regulatory Operations groups to ensure appropriate planning and timely preparation of CMC-related submissions
- Manage answers to questions from Health Authorities related to CMC topics
- 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
- Provide required support to audits/inspections from partners and Health Authorities
- Represent Regulatory CMC in cross-functional project teams
- Ensure alignment with Global CMC team and contribute to the improvement of departmental and cross-functional processes
- Provide guidance and mentor junior staff
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. Furthermore, your profile meets the following criteria:
- Scientific background
- At least 7 years of work experience in Regulatory Affairs CMC, with proven expertise in Biologics
- Good knowledge and appropriate interpretation of guidelines, directives etc
- Experience in projects management : strategic thinking and acting, entrepreneurship skills
- Leadership qualities, diplomacy and respectful behavior
- Strong adaptability, excellent communication and negotiation skills
- Fluent in English and French (good command of both, written and spoken language is mandatory)
You describe yourself as a solution oriented and flexible person who enjoys working in a dynamic environment. Your work is characterized by its accuracy, a proactive approach and by the ability to work under stress and to deal with tight deadlines.
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives. Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world. The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are.