Location: Switzerland - Glattbrugg/Zurich
Function: Regulatory Affairs
Company: Vifor Pharma
We are currently looking for an experienced Regulatory Affairs Manager with focus on the EurAsian Economic Union markets to join our team. You will be responsible of the creation and implementation of robust regulatory strategies based on the good knowledge and appropriate interpretation of guidelines, directives with the particular focus on EAEU legislation developments.
Based in our Headquarters in Glattbrugg/Zurich, you will report to the Regulatory Affairs International Senior Manager CEE&CIS and your responsibilities will include:
- Keeps up to date with the latest regulatory requirements with the focus on the regulatory strategy in EurAsian Economic Union.
- Acts as Single Point of Contact between Regulatory Affairs of the partner company, local regulatory representatives of Vifor Pharma and corporate or regional stakeholders
- Maintains the assigned Regulatory Databases according to internal guidelines
- Manages the response to Health Authority questions / requests for information
- Plans all regulatory activities with the assigned partner companies and ensures timely execution
- Ensures compliance of regulatory dossiers with legal requirements in close collaboration with other functions of Global Regulatory Affairs such as the Therapeutic Groups, Labelling, Ops and CMC
- Responsible for ensuring successful dispatch and submission of new marketing authorizations, life cycle management (variation filings, extension applications etc.) in the assigned territory
- Drive the approval process.
- Cooperation with local industry associations e.g. AIPM, regulatory intelligence and advocacy
- Support GMP inspections of manufacturing sites by competent authorities (i.e. EAEU, Russia, Belarus, Kazakhstan inspections)
- Manage product label information development in accordance with the regional requirements
- Cooperate with internal stakeholders such as Global Drug Safety, Quality and other departments to ensure compliance and alignment with agreed partner support levels
- Act as Deputy to the Line Manager
The successful candidate will bring a Degree in Life Sciences, Pharmaceutical Sciences or Medical and fulfill the following criteria:
- 4 to 6 years of experience in Regulatory Affairs in markets of the EurAsian Economic Union
- Good command of English and fluency in Russian (native speaker level would be an asset)
- Ability to analyze the regulatory requirements (particularly EAEU regulatory, quality and safety guidelines), perform comprehensive gap assessments and build effective regulatory strategies
- Project and matrix team management capabilities (direct/indirect people management experience is an advantage)
- Excellent communication and negotiation skills at all levels, and discretion in the handling of confidential information
- Experience with managing EAEU preparation projects, RU GMP inspection and regulatory activities oversight in CIS markets
- Command of Slovenian or any additional languages in the region
You are a mature regulatory professional, open to new projects and challenges, willing and capable to shape your environment, to setup and to improve work processes, and to influence internal and external stakeholders. Your excellent project management skills will ensure your success in this role.
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.