"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 13,000 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:   

Team Leader Regulatory Global Specialty / Biosimilar Development (f/m/d)   

Bad Vilbel | Deutschland (DE) | Full-time | Permanent 

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.

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
• Flexible working hours and mobile working up to 2 days per week (depending on the job profile)
• Job ticket for the RMV region and Job Bike
• Childcare allowance
• Health-promoting offers such as Wellpass or the STADA Gym (free of charge)
• Numerous additional benefits such as "future payment", group accident insurance, supplementary pension scheme, and chemical industry pension fund
• And much more...

We look forward to receiving your application via our career portal. At jobs.stada.com you will also find numerous other job opportunities, as we are always looking for motivated talents who can strengthen our team with their expertise and personality. Do you have further questions? Then please reach out to recruiting@stada.de

Would you like to find out more about our STADA values? Find out in just 2 minutes with our value game 

STADA Group promotes its diverse culture, regardless of gender, age, social or ethnic origin, disabilities, religion, ideology or sexual orientation. We use the strength of this diversity to develop creative ideas, expand our experience and increase innovative strength. Our focus is on equal opportunities, respectful cooperation and the promotion of an inclusive working environment.