Location: Switzerland - Meyrin/Geneva
Function: Regulatory Affairs
Company: OM Pharma
We are looking for a Regulatory Affairs Manager starting from October2018 for our OM Pharma site in Geneva to support regulatory affairs activities of the OM pharma portfolio. Your main responsabilities are the following:
- Manage successful submissions for new marketing authorisations, renewals, variations and line extensions for various regions worldwide .Coordinate the responses to Q&A and ensure they are handled in a timely manner and in line with the approved product strategy
- Responsibility for the designated regulatory projects with respective deadlines and forecasted budget, from regulatory assessment to strategy implementation
- Collaboration with the CMC, International and submission groups to ensure appropriate planning and timely execution of the regulatory activities
- Ensure compliance of dossiers with legislation and with the general requirements in respective regions
- Support regarding preparation and handling of Aggregate Safety Reports (PBRER, RMP…) according to internal procedures
- Interact with Regulatory authorities, partners and consultants
- Interface with other departments on a national and international level
- Ensure that changes are documented in accordance with internal procedures and are communicated in a timely manner to the Health Authorities
- Ensure tracking tools and regulatory databases are maintained up to date
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 or Medical degree (pharmacy, chemistry or, biochemistry)
- At least 5 years’ experience in Regulatory Affairs worldwide in within a pharmaceutical company
- Fluent in English and French both written and spoken
- Strategic thinking and acting, strong analytical and entrepreneurship skills
You describe yourself as a solution oriented and flexible person who enjoys working in an intercultural 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. Thanks to you strong communication and negotiation skills, you are able to lead projects successfully and to interact with senior stakeholders from different departments.
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.