Team Leader Regulatory Global Specialty/Biosimilar Development

Team Leader Regulatory Global Specialty/Biosimilar Development

Stada

Bad Vilbel, Germany

What you can expect:

• You strengthen roles and responsibilities for individual team members incl. performance reviews and development plans;
• You define and prioritize individual deliverables across the department, closely aligned with overarching department objectives;
• You define relevant KPIs for Regulatory department to assure consistent performance tracking;
• You oversee all regulatory activities in the context of due diligences, health authority interaction and dossier development and review;
• You are responsible for a close monitoring of new regulatory trends, guidance and guidelines and translation into potential impact assessment on STADA Specialty and Biosimilar business;
• You identify, develop and implement state-of-the art processes best-in-class tools;
• You are the representative in management boards as required, both internally but also with external, (co)-collaboration partners and the
• You are the go-to expert for all kind of global & loval Regulatory questions;
• You are deputy of Head Global Specialty Development and sparring partner for VP Global Speciality Development.

Who we are looking for:

• You hold a Master degree in Life Science and a Ph.D;
• You have 15+ years of experience in Pharmaceutical industry;
• You have 8 + years of experience in Regulatory affairs incl. global positions;
• You have proven track record of achieving drug approvals from different health authorities, in particular FDA, EMA, Swissmedic, additional experience with e.g. COFEPRIS, ANVISA, PMDA, NMPA, etc. is a plus;
• You are familiar with the broad coverage of regulatory topics from CMC, Clinical, Devices, labelling, pre-approval inspections, etc.;
• You have proven track record as team leader either in line or matrix setting;
• You bring a robust understanding of Biologics / recombinant molecules, ideally also Biosimilars;
• You are an experienced user of regulatory intelligence software, publishing tools and document management software (preparation of eCTDs);
• You bring strong verbally and written communication skills;
• You support the appreciative and cooperative working in a global and cross-functional environment with your strong teamwork skills;
• You are an entrepreneur with proactive and agile working style – resilient in facing ambiguity at the same time efficiently deploying project management skills;
• You are open-minded and curious to explore new ways of working;
• Your knowledge in English is excellent, any other language(s) is (are) a plus.

Apply Now

More Job Searches

Germany      Clinical Research      Manager and Executive      Regulatory Affairs      Stada