Due to expansion of our product portfolio and growth in our LATAM region, Vifor Pharma has an opportunity for an experienced regulatory professional to join our affiliate in Brazil as the Head of Regulatory Affairs. The Head of Regulatory Affairs Brazil role will be on the leadership team of the General Manager for Brazil.
Representing Vifor Global Regulatory in Brazil
Support the compilation, submission and maintenance of NDA, in alignment with RA International strategy
Supporting Global Regulatory Affairs in the development and monitoring of long & short-term product regulatory planning related to new registration and life cycle management in Brazil
Developing and evaluating registrations strategies to ensure effective achievement of regulatory/business objectives, approvals, and optimal labels.
Monitor national registration requirements through reviews of websites, publications, seminars, and similar sources, and communicate requirements to GRA and local staff.
Proactively addressing industry trends and opportunities, and key regulatory trends related to registration requirements supporting new product approval
Act as primary Vifor Regulatory affairs representative in front of the ANVISA
Coordinate and support the transition of the MA transfer to a new partner.
Develop advocacy, support Authority management with stakeholder mapping and proactively build and strengthen external stakeholder contacts (external experts, industry organizations, etc) in Brazil
Registered Pharmacist is preferred
University degree, preferably in pharmaceutical or health related field
Minimum 10 years in equivalent position in multinational companies in regulatory affairs in in the pharmaceutical industry (prescription drugs)
Proven, first-hand experience of working in a fast-paced team environment
Proven, first-hand experience of NDA submission in Brazil
Experience in working in a matrix organization and multidisciplinary team within the pharmaceutical industry
Familiarity with the global regulatory environment and GCP regulations
Able to influence regulatory policy shaping in Brazil in different spheres such as Federal Government, Estate and Municipalities
High familiar with CEMED processes and the ability to bridge price, registration and patient needs
High credibility with Brazilian authorities and Pharma associations
Have submitted minimum 10 products in the Brazilian market, with vast experience in launches)
Very good understanding on manufacturing, QQ and QA
Other Preferred Requirements
Experience in pharmacovigilance regulations and clinical development
Experience in Quality Assurance and the stablish of a company as importer and distributor at ANVISA Level
The Vifor Pharma Group is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care); and OM Pharma.
Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).
For more information, please visit www.viforpharma.com/career