Senior Director Regulatory Global Specialty / Biosimilar Development (f/m/d)

"Caring for People's Health as a Trusted Partner" - This mission motivates us at STADA every day to improve the health of people worldwide. With our wide range of generics, consumer health products and specialty pharmaceuticals, we offer patients, doctors and pharmacists a wide range of therapeutic options.

 

Around 11,700 employees live our values of Integrity, Entrepreneurship, Agility and One STADA. Together we are on an exciting growth journey and want to successfully shape the future of STADA. 

 

Do you want to become part of a dynamic, international team and grow with us? Then apply now as:   

 

Senior Director Regulatory Global Specialty / Biosimilar Development (f/m/d)   

Bad Vilbel | Germany (DE) | Full-time | Permanent | Portfolio & Product Development | Professionals 

 

What you can expect

 

• You define clear roles and responsibilities for individual team members
• You define and prioritize individual deliverables across the department, closely aligned with overarching department objectives
• You develop individuals and assure the overall team performance
• You are responsible for the definition of relevant KPIs for Regulatory department to assure consistent performance tracking
• You have the oversight of all regulatory activities incl. Contribution to due diligences if applicable and preparation of regulatory interactions and assurance of delivery of all regulatory documents
• You close monitoring of new regulatory trends, guidance and guidelines and translation into potential impact assessment on STADA Specialty and Biosimilar business
• You take care of the development and implementation on state-of-the art processes
• You are responsible for the identification and implementation of best-in-class tools to support the department and the team
• You are the go-to expert for all kind of global & local Regulatory questions Deputy • You are the Deputy of Head Global Specialty Development

 

Who we are looking for

 

• You have a Master in Life Science, Ph.D.
• You have 15+ years of experience in Pharmaceutical industry and 8 + years of experience in Regulatory affairs incl. global positions
• You have a 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 have a broad coverage of regulatory topics from CMC, Clinical, Devices, labelling, pre-approval inspections, etc.
• You have a proven track record as team leader either in line or matrix setting • You bring a Robust understanding of Biologics / recombinant molecules, ideally also Biosimilars with you
• You are an experienced user of regulatory intelligence software, publishing tools and document management software (preparation of eCTDs)
• You are a strong communicator, both verbally and in writing
• You are a team player, proven to be successfully working in global and cross-functional environments
• Your focus is 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
• You have excellent knowledge in English, any other language(s) as German are a plus

 

What we offer

 

• An open corporate culture with fast decision-making processes and a lot of potential for your personal development
• Individual development and training opportunities