STADA Arzneimittel AG
61118 Bad Vilbel - Deutschland
Director Regulatory Affairs (Pharma/Life Science)
Arbeit
Vollzeit
ab 15.01.2026
Beschreibung
STADA Arzneimittel GmbH
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 departme... weiter lesen
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 departme... weiter lesen
STADA Arzneimittel GmbH
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 represent Global Specialty/Biosimilar development in management boards
* 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 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 represent Global Specialty/Biosimilar development in management boards
* 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
Ref-Nr.: 8720608
Aktualisiert:
15.01.2026
Quelle: Bundesagentur für Arbeit
weitere Infos Rechtliche Hinweise zur Nutzung
Ob die Stelle noch verfügbar ist und weitere Informationen findest du direkt auf der Website der Bundesagentur für Arbeit. Bitte beachte: OPROMA ist nicht der Anbieter dieser Stelle und kann keine Auskünfte geben.
weitere Infos Rechtliche Hinweise zur Nutzung
Ob die Stelle noch verfügbar ist und weitere Informationen findest du direkt auf der Website der Bundesagentur für Arbeit. Bitte beachte: OPROMA ist nicht der Anbieter dieser Stelle und kann keine Auskünfte geben.
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