Head Regulatory Affairs - Brazil

Lieu: Brazil - Sao Paulo

Fonction: Regulatory Affairs

Medha Khanna

Senior Talent Acquisition Manager

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Votre 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


A propos de nous

Le groupe Vifor Pharma est une entreprise pharmaceutique internationale spécialisée. Son ambition est de devenir le leader mondial dans les domaines de la carence en fer, de la néphrologie et des traitements cardio-rénaux. L’entreprise est le partenaire de choix pour les médicaments et les solutions innovantes axées sur le patient. Le groupe Vifor Pharma aspire à aider les patients du monde entier atteints de maladies graves et chroniques à mener une vie meilleure et plus saine. La société développe, fabrique et commercialise des produits pharmaceutiques offrant des soins de précision aux patients. Le groupe Vifor Pharma occupe une position de premier plan dans toutes ses activités clés. Il se compose des entreprises suivantes: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (sa société commune avec Fresenius Medical Care); et OM Pharma.

Le groupe Vifor Pharma a son siège en Suisse et est coté à la Bourse suisse (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

Pour de plus amples informations, veuillez consulter www.viforpharma.com/career

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