Senior Regulatory Affairs Analyst

São Paulo Permanente View Job Description
The Senior Regulatory Affairs Analyst is responsible for managing regulatory submissions and ensuring compliance with local and international regulations. This role requires expertise in regulatory processes, biological drugs, project management, attention to detail, and effective interaction with regulatory bodies.

Atualizada 13/03/2025

  • Reside in sao paulo
  • Fluent English

Sobre nosso cliente

Multinational company focused on commitment to public health, quality, and innovation. It operates in both the public and private healthcare sectors in Brazil.

Descrição

* Prepare and submit regulatory documents for new product registrations, modifications, and renewals, ensuring compliance with ANVISA and other
international authorities.
* Assist in developing regulatory strategies for biological drugs, ensuring alignment with regulatory requirements.
* Support project management activities, ensuring timely delivery of regulatory submissions and approvals.
* Monitor regulatory changes and assess their impact on the company's products.
* Communicate with regulatory authorities (ANVISA, FDA, EMA) during approval processes and audits.
* Maintain and update regulatory documentation for compliance.
* Collaborate with cross-functional teams (R&D, QA) to ensure regulatory requirements are met.

Perfil desejável

* Bachelor's degree in Pharmacy, Chemistry, Biomedicine, or related fields. Postgraduate qualifications in Regulatory Affairs are a plus.
* Experience in Regulatory Affairs, particularly with biological drugs, in the pharmaceutical industry.
* Strong knowledge of regulatory guidelines, approval processes, and project management principles.
* Proficiency in English (written and spoken - fluent).

O que está sendo ofertado

* Competitive salary - PJ
* Company benefits.

Contato
Stephanie Jeronymo
Referência da Vaga
JN-032025-6690153

Resumo da vaga

Setor
Saúde & Life Sciences
Subsetor
Life Sciences
Indústria
Healthcare / Pharmaceutical
Localização
São Paulo
Tipo de contratação
Permanente
Nome do consultor
Stephanie Jeronymo
Referência da vaga
JN-032025-6690153