STADA Arzneimittel AG
Senior Director Regulatory Global Specialty / Biosimilar Development(m/w/x)
Full-time/Part-timeWith HomeofficeSenior
Bad Vilbel
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STSTADA Arzneimittel AG
Senior Director Regulatory Global Specialty / Biosimilar Development(m/w/x)
Bad Vilbel
Full-timeWith Home OfficeSenior
Nejo AI Summary
Directing global regulatory strategy for specialty products in consumer healthcare. 15+ years pharmaceutical industry, 8+ years regulatory affairs, and team leadership experience required. Mobile working up to 2 days per week, plus RMV job ticket.
Requirements
- Master or PhD in Life Science
- 15+ years of experience in Pharmaceutical industry and 8+ years in Regulatory affairs
- Proven track record of achieving drug approvals from health authorities
- Broad coverage of regulatory topics from CMC, Clinical, Devices, labelling, pre-approval inspections
- Proven track record as team leader in line or matrix setting
- Robust understanding of Biologics, recombinant molecules, and ideally Biosimilars
- Experienced user of regulatory intelligence software, publishing tools, and document management software
- Team player in global and cross-functional environments
- Entrepreneurial with proactive and agile working style
- Open-minded and curious to explore new ways of working
- Excellent knowledge in English, any other language(s) like German are a plus
Tasks
- Oversee all regulatory aspects of the department
- Act as deputy to the Head of Global Specialty Development
- Lead the team to drive strategic direction
- Define clear roles and responsibilities for team members
- Align individual deliverables with departmental objectives
- Establish relevant KPIs to track regulatory performance
- Oversee regulatory activities, including due diligence contributions
- Prepare for and participate in regulatory interactions with health authorities
- Ensure timely delivery of high-quality regulatory documents for new applications
- Manage lifecycle activities for post-approval variations and submissions
- Monitor new regulatory trends and guidelines
- Translate regulatory trends into impact assessments for the business
- Implement best-in-class tools and processes for the department
- Act as a sparring partner for strategic discussions on Specialty & Biosimilar assets
- Represent Global Specialty/Biosimilar development in management boards
- Serve as the go-to expert for global and local regulatory questions
Work Experience
- 15 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- regulatory intelligence software
- publishing tools
- document management software
Benefits
Flexible Working
- Flexible working hours
- Mobile working up to 2 days per week
Informal Culture
- Open corporate culture
Learning & Development
- Individual development opportunities
Public Transport Subsidies
- Job ticket for RMV region
Company Bike
- Job Bike
Additional Allowances
- Childcare allowance
Healthcare & Fitness
- Health-promoting offers
Other Benefits
- Group accident insurance
Retirement Plans
- Supplementary pension scheme
Free or Subsidized Food
- Subsidized cafeteria
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of STADA Arzneimittel AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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STSTADA Arzneimittel AG
Senior Director Regulatory Global Specialty / Biosimilar Development(m/w/x)
Bad Vilbel
Full-timeWith Home OfficeSenior
Nejo AI Summary
Directing global regulatory strategy for specialty products in consumer healthcare. 15+ years pharmaceutical industry, 8+ years regulatory affairs, and team leadership experience required. Mobile working up to 2 days per week, plus RMV job ticket.
Requirements
- Master or PhD in Life Science
- 15+ years of experience in Pharmaceutical industry and 8+ years in Regulatory affairs
- Proven track record of achieving drug approvals from health authorities
- Broad coverage of regulatory topics from CMC, Clinical, Devices, labelling, pre-approval inspections
- Proven track record as team leader in line or matrix setting
- Robust understanding of Biologics, recombinant molecules, and ideally Biosimilars
- Experienced user of regulatory intelligence software, publishing tools, and document management software
- Team player in global and cross-functional environments
- Entrepreneurial with proactive and agile working style
- Open-minded and curious to explore new ways of working
- Excellent knowledge in English, any other language(s) like German are a plus
Tasks
- Oversee all regulatory aspects of the department
- Act as deputy to the Head of Global Specialty Development
- Lead the team to drive strategic direction
- Define clear roles and responsibilities for team members
- Align individual deliverables with departmental objectives
- Establish relevant KPIs to track regulatory performance
- Oversee regulatory activities, including due diligence contributions
- Prepare for and participate in regulatory interactions with health authorities
- Ensure timely delivery of high-quality regulatory documents for new applications
- Manage lifecycle activities for post-approval variations and submissions
- Monitor new regulatory trends and guidelines
- Translate regulatory trends into impact assessments for the business
- Implement best-in-class tools and processes for the department
- Act as a sparring partner for strategic discussions on Specialty & Biosimilar assets
- Represent Global Specialty/Biosimilar development in management boards
- Serve as the go-to expert for global and local regulatory questions
Work Experience
- 15 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- regulatory intelligence software
- publishing tools
- document management software
Benefits
Flexible Working
- Flexible working hours
- Mobile working up to 2 days per week
Informal Culture
- Open corporate culture
Learning & Development
- Individual development opportunities
Public Transport Subsidies
- Job ticket for RMV region
Company Bike
- Job Bike
Additional Allowances
- Childcare allowance
Healthcare & Fitness
- Health-promoting offers
Other Benefits
- Group accident insurance
Retirement Plans
- Supplementary pension scheme
Free or Subsidized Food
- Subsidized cafeteria
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of STADA Arzneimittel AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
STADA Arzneimittel AG
Industry
Pharmaceuticals
Description
Das Unternehmen ist auf Consumer Healthcare spezialisiert und bietet hochwertige Produkte zur Gesundheitsvorsorge an.
Not a perfect match?
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