STADA Arzneimittel AG
Senior Director Regulatory Global Specialty / Biosimilar Development (f/m/d)
STADA Arzneimittel AG, New Bremen, Ohio, United States
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"Caring for People\'s Health as a Trusted Partner" - This purpose 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) What you can expect As Senior Director Regulatory Global Specialty / Biosimilar Development (f/m/d), you will oversee all regulatory aspects of the department, act as deputy to the Head of Global Specialty Development, and lead your team to drive strategic direction and ensure the successful execution of projects.
You define clear roles and responsibilities and develop individual team members
You prioritize and align individual deliverables across the department with overarching objectives
You define relevant KPIs for the Regulatory department to consistently track performance
You oversee all regulatory activities, including contribution to due diligences
You prepare for and participate in all regulatory interactions with health authorities
You ensure the timely and high-quality delivery of all regulatory documents for new applications and life cycle management activities (post-approval variations/submissions, lifecycle management)
You closely monitor new regulatory trends, guidance, and guidelines, translating them into impact assessments for Specialty and Biosimilar business
You implement best-in-class tools and state-of-the-art processes to support the department
You act as a sparring partner for the VP Global Specialty Development in strategic discussions on Specialty & Biosimilar assets
You serve as the go‑to expert for all global and local regulatory questions
Who we are looking for
You have a Master or PhD in Life Science
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
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 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
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 group accident insurance or supplementary pension scheme
We look forward to receiving your application via ourcareer 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 . We will consider requests to work part‑time on an individual basis. Please contact us in advance by e-mail (recruiting@stada.de .) and let us know how many hours per week you would like to work.
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.
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"Caring for People\'s Health as a Trusted Partner" - This purpose 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) What you can expect As Senior Director Regulatory Global Specialty / Biosimilar Development (f/m/d), you will oversee all regulatory aspects of the department, act as deputy to the Head of Global Specialty Development, and lead your team to drive strategic direction and ensure the successful execution of projects.
You define clear roles and responsibilities and develop individual team members
You prioritize and align individual deliverables across the department with overarching objectives
You define relevant KPIs for the Regulatory department to consistently track performance
You oversee all regulatory activities, including contribution to due diligences
You prepare for and participate in all regulatory interactions with health authorities
You ensure the timely and high-quality delivery of all regulatory documents for new applications and life cycle management activities (post-approval variations/submissions, lifecycle management)
You closely monitor new regulatory trends, guidance, and guidelines, translating them into impact assessments for Specialty and Biosimilar business
You implement best-in-class tools and state-of-the-art processes to support the department
You act as a sparring partner for the VP Global Specialty Development in strategic discussions on Specialty & Biosimilar assets
You serve as the go‑to expert for all global and local regulatory questions
Who we are looking for
You have a Master or PhD in Life Science
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
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 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
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 group accident insurance or supplementary pension scheme
We look forward to receiving your application via ourcareer 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 . We will consider requests to work part‑time on an individual basis. Please contact us in advance by e-mail (recruiting@stada.de .) and let us know how many hours per week you would like to work.
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.
#J-18808-Ljbffr