Head Regulatory Affairs - Brazil

Ort: Brazil - Sao Paulo

Funktion: Regulatory Affairs

Medha Khanna

Senior Talent Acquisition Manager

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Ihr Profil

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.

Key responsibilities

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

Requirements:

Minimum Requirements

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


Über uns

Die Vifor Pharma Gruppe ist ein globales Spezialitäten-Pharmaunternehmen. Sie hat sich zum Ziel gesetzt, globale Marktführerin in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu werden. Das Unternehmen ist der bevorzugte Partner für Pharmaprodukte und innovative, patientenorientierte Lösungen. Die Vifor Pharma Gruppe will Patienten mit schweren und chronischen Krankheiten auf der ganzen Welt dabei helfen, ein Leben in besserer Gesundheit zu führen. Das Unternehmen entwickelt, produziert und vermarktet pharmazeutische Produkte für eine optimale Patientenversorgung. Die Vifor Pharma Gruppe nimmt in allen ihren Kerngeschäften eine führende Position ein und besteht aus folgenden Unternehmen: Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma (ein gemeinsam mit Fresenius Medical Care geführtes Unternehmen); und OM Pharma.

Die Vifor Pharma Gruppe hat ihren Hauptsitz in der Schweiz und ist an der Schweizer Börse (SIX Swiss Exchange, VIFN, ISIN: CH0364749348) kotiert.

Weitere Informationen finden Sie auf www.viforpharma.com/career

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