- Excellent opportunity for your professional development.
- Opportunity to integrate a project with excellent growth possibilities.
Sobre o nosso cliente
International pharmaceutical company.
- 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.
- 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.
Excellent opportunity for your professional development.