Vaxcyte
Executive Director, Regulatory Affairs(m/w/x)
Full-timeFreelanceOn-siteSenior
Zug, Visp
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CYCytokinetics
Director, Regulatory Affairs CMC(m/w/x)
Zug
Full-timeOn-siteSenior
Nejo AI Summary
Developing global regulatory strategies for first-in-class muscle activators and inhibitors. 8+ years in biotech/pharma regulatory roles, with small molecule and cardiovascular experience required. Focus on late-stage drug development.
Requirements
- 10-12+ years of related work experience
- 8+ years in Regulatory Affairs CMC in Biotech/Pharmaceutical industry
- Experience in small molecule drug development
- Experience in cardiovascular therapeutic area
- Proven experience as primary RA-CMC contact to Health Authorities
- Bachelor’s degree in chemistry or related field
- Advanced degree preferred
- Excellent working knowledge of international regulatory requirements
- Solid working knowledge of core processes in small molecules
- Experience with eCTD requirements and electronic submissions
- Experience with international regulatory submissions
- Ability to work effectively across teams and functions
- Excellent oral and written communication skills
- Excellent organizational skills and attention to detail
Tasks
- Formulate CMC regulatory strategies based on current regulatory intelligence
- Collaborate with cross-functional project teams to develop CMC regulatory strategies
- Identify regulatory risks and represent the department in project teams
- Determine required documentation and manage delivery of approved technical documents
- Prepare, author, and maintain regulatory submission documents for global applications
- Evaluate manufacturing changes for potential product impact
- Review CMC documentation supporting regulatory submissions and communications
- Coordinate responses to queries from regulatory authorities focused on CMC
- Maintain knowledge of FDA/EMA regulations and ICH guidelines
- Ensure conformance to commitments made with regulatory agencies
- Provide regulatory advice to other functional areas
- Participate in regulatory due diligence activities
- Build and maintain relationships with internal and external business partners
- Develop collaborative relationships with other departments for effective communication
- Manage relationships with external vendors and regulatory health authorities
- Coordinate meetings and conferences with FDA, EMA, and other regulatory authorities
- Collaborate with regulatory colleagues to provide CMC expertise
- Develop and implement regulatory operating guidelines and strategies within the team
Work Experience
- 10 - 12 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
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.
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CYCytokinetics
Director, Regulatory Affairs CMC(m/w/x)
Zug
Full-timeOn-siteSenior
Nejo AI Summary
Developing global regulatory strategies for first-in-class muscle activators and inhibitors. 8+ years in biotech/pharma regulatory roles, with small molecule and cardiovascular experience required. Focus on late-stage drug development.
Requirements
- 10-12+ years of related work experience
- 8+ years in Regulatory Affairs CMC in Biotech/Pharmaceutical industry
- Experience in small molecule drug development
- Experience in cardiovascular therapeutic area
- Proven experience as primary RA-CMC contact to Health Authorities
- Bachelor’s degree in chemistry or related field
- Advanced degree preferred
- Excellent working knowledge of international regulatory requirements
- Solid working knowledge of core processes in small molecules
- Experience with eCTD requirements and electronic submissions
- Experience with international regulatory submissions
- Ability to work effectively across teams and functions
- Excellent oral and written communication skills
- Excellent organizational skills and attention to detail
Tasks
- Formulate CMC regulatory strategies based on current regulatory intelligence
- Collaborate with cross-functional project teams to develop CMC regulatory strategies
- Identify regulatory risks and represent the department in project teams
- Determine required documentation and manage delivery of approved technical documents
- Prepare, author, and maintain regulatory submission documents for global applications
- Evaluate manufacturing changes for potential product impact
- Review CMC documentation supporting regulatory submissions and communications
- Coordinate responses to queries from regulatory authorities focused on CMC
- Maintain knowledge of FDA/EMA regulations and ICH guidelines
- Ensure conformance to commitments made with regulatory agencies
- Provide regulatory advice to other functional areas
- Participate in regulatory due diligence activities
- Build and maintain relationships with internal and external business partners
- Develop collaborative relationships with other departments for effective communication
- Manage relationships with external vendors and regulatory health authorities
- Coordinate meetings and conferences with FDA, EMA, and other regulatory authorities
- Collaborate with regulatory colleagues to provide CMC expertise
- Develop and implement regulatory operating guidelines and strategies within the team
Work Experience
- 10 - 12 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
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.
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