BridgeBio Pharma
Senior Director, Market Access, Europe Central Region(m/w/x)
Full-timeWith HomeofficeSenior
München, Zug
New Job?Nejo!
Your personal AI career agent
CYCytokinetics
Director, Regulatory Affairs, Europe(m/w/x)
Zug
Full-timeFreelanceWith Home OfficeSenior
Nejo AI Summary
Leading European regulatory strategy and MAA submissions for cardiovascular biopharmaceuticals. 10+ years of European regulatory expertise required. Collaboration with global teams and cross-functional departments.
Requirements
- Minimum 10 years relevant experience
- Expertise in European regulatory regulations
- Bachelor of Science in scientific discipline
- Pharm D or PhD preferred
- Fluency in English
- Other key EU market languages advantage
- Leading MAA through EMA centralized procedure
- Leading MAA through national agencies
- Experience in international markets advantageous
- Leading regulatory agency interactions
- Participating in regulatory agency interactions
- Solid foundation in science
- Strong team player
- Engaged, hands-on professional
- Collaborative and independent work
- Excellent verbal communication skills
- Excellent written communication skills
- Excellent planning skills
- Excellent organization skills
- Excellent time management skills
- Ability to support multiple projects
- Ability to prioritize multiple projects
- Strong interpersonal capabilities
- Ability to build networks
- Ability to maintain networks
- Sense of urgency
- Identifies challenges and problems
- Initiative to identify solutions
Tasks
- Develop and execute regulatory strategies for European programs
- Lead submission of Marketing Authorization Applications for Cytokinetics products
- Implement post-marketing requirements for European products
- Collaborate with the Global Regulatory Lead and Global Regulatory Team
- Work cross-functionally with Clinical Research, Medical Affairs, Drug Safety, Quality, Market Access, and country operations
- Maintain awareness of the European regulatory environment
- Communicate the impact of regulatory changes on business and product development
- Develop a robust European strategy for specific products
- Contribute to and execute filing plans for Europe
- Ensure high-quality regulatory submissions are timely and meet Cytokinetics requirements
- Review and provide strategic input on EU CTR submissions and queries
- Provide direction on regional and local regulatory mechanisms
- Contribute to EMA and national agencies interactions and preparations
- Stay informed about new and developing legislation and regulatory policies
- Discuss implications of regulatory changes with the business
- Provide regulatory input to market access strategy and HTA plans
- Ensure all post-marketing requirements and maintenance activities are met
- Work with the Quality department on European regulatory procedures
Work Experience
- 10 years
Education
- Compulsory education
Languages
- English – Fluent
- German – Basic
- French – Basic
- Spanish – Basic
- Italian – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Cytokinetics 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.
Not a perfect match?
- Alnylam Pharmaceuticals
Associate Director, Marketing - International TTR BU(m/w/x)
Full-timeWith HomeofficeSeniorZug - AbbVie
Affiliate Safety Representative (ASR)(m/w/x)
Full-timeWith HomeofficeExperiencedCham - Apellis Pharmaceuticals, Inc.
Senior Manager, Drug Substance MSAT(m/w/x)
Full-timeWith HomeofficeSeniorZug - Alexion, AstraZeneca Rare Diseases
Rare Disease Partner Hematology/Nephrology(m/w/x)
Full-timeWith HomeofficeExperiencedBaar
CYCytokinetics
Director, Regulatory Affairs, Europe(m/w/x)
Zug
Full-timeFreelanceWith Home OfficeSenior
Nejo AI Summary
Leading European regulatory strategy and MAA submissions for cardiovascular biopharmaceuticals. 10+ years of European regulatory expertise required. Collaboration with global teams and cross-functional departments.
Requirements
- Minimum 10 years relevant experience
- Expertise in European regulatory regulations
- Bachelor of Science in scientific discipline
- Pharm D or PhD preferred
- Fluency in English
- Other key EU market languages advantage
- Leading MAA through EMA centralized procedure
- Leading MAA through national agencies
- Experience in international markets advantageous
- Leading regulatory agency interactions
- Participating in regulatory agency interactions
- Solid foundation in science
- Strong team player
- Engaged, hands-on professional
- Collaborative and independent work
- Excellent verbal communication skills
- Excellent written communication skills
- Excellent planning skills
- Excellent organization skills
- Excellent time management skills
- Ability to support multiple projects
- Ability to prioritize multiple projects
- Strong interpersonal capabilities
- Ability to build networks
- Ability to maintain networks
- Sense of urgency
- Identifies challenges and problems
- Initiative to identify solutions
Tasks
- Develop and execute regulatory strategies for European programs
- Lead submission of Marketing Authorization Applications for Cytokinetics products
- Implement post-marketing requirements for European products
- Collaborate with the Global Regulatory Lead and Global Regulatory Team
- Work cross-functionally with Clinical Research, Medical Affairs, Drug Safety, Quality, Market Access, and country operations
- Maintain awareness of the European regulatory environment
- Communicate the impact of regulatory changes on business and product development
- Develop a robust European strategy for specific products
- Contribute to and execute filing plans for Europe
- Ensure high-quality regulatory submissions are timely and meet Cytokinetics requirements
- Review and provide strategic input on EU CTR submissions and queries
- Provide direction on regional and local regulatory mechanisms
- Contribute to EMA and national agencies interactions and preparations
- Stay informed about new and developing legislation and regulatory policies
- Discuss implications of regulatory changes with the business
- Provide regulatory input to market access strategy and HTA plans
- Ensure all post-marketing requirements and maintenance activities are met
- Work with the Quality department on European regulatory procedures
Work Experience
- 10 years
Education
- Compulsory education
Languages
- English – Fluent
- German – Basic
- French – Basic
- Spanish – Basic
- Italian – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Cytokinetics 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
Cytokinetics
Industry
Pharmaceuticals
Description
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on developing first-in-class muscle activators and inhibitors.
Not a perfect match?
- BridgeBio Pharma
Senior Director, Market Access, Europe Central Region(m/w/x)
Full-timeWith HomeofficeSeniorMünchen, Zug - Alnylam Pharmaceuticals
Associate Director, Marketing - International TTR BU(m/w/x)
Full-timeWith HomeofficeSeniorZug - AbbVie
Affiliate Safety Representative (ASR)(m/w/x)
Full-timeWith HomeofficeExperiencedCham - Apellis Pharmaceuticals, Inc.
Senior Manager, Drug Substance MSAT(m/w/x)
Full-timeWith HomeofficeSeniorZug - Alexion, AstraZeneca Rare Diseases
Rare Disease Partner Hematology/Nephrology(m/w/x)
Full-timeWith HomeofficeExperiencedBaar