Senior Regulatory Project Manager (M/F)

Lisboa Indefinido

Added 15/03/2021

  • Excellent opportunity for your professional development.
  • Opportunity to integrate a project with excellent growth possibilities.

Sobre o nosso cliente

International pharmaceutical company.

Descrição

Main Responsibilities:

  • Supports the Global Regulatory Strategist (GRS) in the development and implementation of the global regulatory strategy for assigned marketed global brands/development compounds;
  • Delivers smart tactical plans to properly execute agreed regulatory strategies in collaboration with the regulatory sub team (e.g. regulatory submission, dossiers submission, flagging risks, overseeing regulatory submission and procedure management.);
  • Works flexibly within and across regions to provide broad tactical support and to ensure the delivery of product team and business objectives;
  • Responsible to liaise with the relevant functional experts and participate in cross-functional teams as agreed in regulatory sub team;
  • Identifies and leads regulatory initiatives leading to process improvement and development of specialized expertise as needed (SOPs regulatory standards, BPDs etc.);
  • Serves as business partner for strategies for CoGs optimization and drives creation and updates of product information (as such regularly leads the Label Management Task Team (LMTT));
  • Monitors changes in regulatory guidelines and competitive landscape in the relevant territories and analyses & shares potential impact these changes;
  • Supports due diligence activities for in-licensing opportunities and other projects with high- quality regulatory assessments that allow proper valuation of these opportunities/projects.

Perfil ideal

Ideal Profile:

  • Academic training in Life Science (pharmacy, biology, chemistry or related discipline);
  • At least 5-10 years of experience in the pharmaceutical industry or health authority;
  • Regulatory experience in a global setting, main territorial focus: European Union/US and Latin
  • America, Experience in APAC beneficial;
  • Track record of having delivered competitive regulatory approvals in EU/US and/or Japan;
  • In-depth knowledge of relevant ICH/EU/US guidelines and regulations covering all aspects of
  • regulatory submission and procedure management;
  • Sound understanding of relevant scientific and/or technical aspects of drug development and
  • life cycle management;
  • Fluency in English, both written and spoken, German or Spanish are a plus.

Vantagens

Excellent opportunity for your professional development.

Pesquise mais Ofertas
Catarina Falcão
Quote job ref
JN-032021-2180276

Resumo da Função

Localização
Tipo de contrato
Nome do Consultor
Catarina Falcão
Referência da Oferta
JN-032021-2180276

Na Michael Page, acreditamos na Diversidade e Inclusão. Defendemos a igualdade de oportunidades sem discriminar por género, raça, ideia, religião, orientação sexual ou qualquer outro aspeto que possa ser considerado discriminatório ou de exclusão.