Location: Switzerland - Glattbrugg/Zurich
Function: Regulatory Affairs
Company: Vifor Pharma
We are currently looking for an experienced Regulatory Affairs Manager with focus on the Latin America markets to join our team. You will be responsible for the creation and implementation of robust regulatory strategies for the assigned portfolio based on the good knowledge and appropriate interpretation of guidelines and directives. Based in our Operational Headquarters in Glattbrugg, you will report to Head of Regulatory Affairs Partner Business Central & Eastern Europe & Latin America and your responsibilities will include:
- Keep up to date with the latest regulatory requirements in Latin America
- Create robust regulatory strategies based on the good knowledge and appropriate interpretation of the relevant guidelines and directives
- Act as single point of contact between Regulatory Affairs of the partner company, regional regulatory representatives of Vifor Pharma Group and corporate or regional stakeholders
- Plan all regulatory activities with the Regional Regulatory Affairs, partner companies and other Global Regulatory Affairs functions and ensure timely execution
- Be accountable for successful dispatch and submission of new marketing authorisations, and for effective and compliant regulatory life cycle management (variation, extension applications etc.) for the assigned portfolio in the region
- Ensure compliance of regulatory dossiers with legal requirements in close collaboration with other functions of Global Regulatory Affairs such as the Therapeutic Groups, Labelling, Operations and CMC
- Drive the approval process
- Maintain the assigned Regulatory Databases according to internal guidelines
- Manage the preparation of the responses to Health Authority questions / requests for information
- Manage product labelling information updates in accordance with the company and 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
The successful candidate will bring a degree in Life Sciences, Pharmaceutical Sciences or equivalent and fulfil the following criteria:
- Minimum 5 years of experience in Regulatory Affairs
- Ability to analyse the regulatory requirements (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 and experience in the global roles/matrix teams is an advantage)
- Excellent communication and negotiation skills at all levels, and discretion in the handling of confidential information
- Successful track records of new products registration in LATAM region, exposure to orphan products, experience with RA Labelling and regulatory information management systems implementation/key user exposure would be considered as a plus
- Business fluency in English. Command of regional (Spanish, Portuguese) and/or manufacturing sites (German) languages is an advantage
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. You are a strategic thinker with good analytical skills and result-oriented mindset. Your excellent project management skills will ensure your success in this role. You act as a role model for others in line with Vifor Pharma values.
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.