Director Regulatory CMC
vor 16 Stunden
Join our organization as aDirector, Global Regulatory Affairs CMCwhere you will be responsible for developing and executing regulatory CMC strategies for lifecycle management. You will drive global strategy across the existing portfolio, lead a team, and ensure effective delivery in a complex matrix environment. Reporting to the Head of Global Regulatory Affairs CMC you will partner broadly across the organization to influence priorities and strengthen communication and decision-making processes. This is a leadership role and part of the SLT.How you will contributeIndependently manage regulatory submissions for assigned compounds, including global marketing applications and post-approval lifecycle activities.Evaluate change proposals for global regulatory impact and plan global variations and amendments.Serve as a member of global teams, providing expert interpretation of applicable EMA/FDA/ICH/WHO/global regulations to ensure CMC compliance.Lead team members responsible for establishing CMC content requirements (data and documentation) for regulatory submissions and review content for compliance with these requirements.Ensure project teams, line management, and key stakeholders are informed of developments that may impact regulatory success, exercising sound judgement and communicating in a timely and professional manner. Provide solutions to prevent recurrence of issues.Interact directly with international Health Authorities; participate in and facilitate agency meetings.Stay current with evolving regulatory CMC requirements, apply this knowledge to assigned projects, and share learnings to support team development.Maintain constructive relationships with internal colleagues, external partners, and Health Authority representatives.What you bringBS/BA degree in a scientific discipline; an advanced degree is preferred.15+ years of pharmaceutical regulatory CMC experience, including experience as a Regulatory CMC product lead, or equivalent experience in related functions (e.g., Pharmaceutical Development, Analytical Development, Manufacturing, Quality Assurance).Experience with active pharmaceutical ingredients/drug substances, small molecules.Expertise in developing alternative regulatory strategies based on global guidance and regulations.Proven experience leading interactions with Regulatory Agencies for CMC submissions and product development meetings; international experience preferred.Strong understanding of scientific principles and global regulatory CMC requirements relevant to drug development and post-market support, with the ability to apply this knowledge across lifecycle management.Ability to provide sound regulatory advice and make reasoned decisions in areas with limited or ambiguous regulatory guidance.Demonstrated leadership, problem-solving ability, flexibility, and strong collaboration skills.Ability to think strategically at an enterprise level and influence stakeholders across a complex matrix environment.Sound judgement in escalating and communicating actual or potential issues, and in presenting solutions.Ability to build and maintain a team environment that inspires and enables progress.Expertise in CTD authoring and/or review throughout the product lifecycle, with a solid understanding of global submission complexities.
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Director, Regulatory Affairs CMC Europe
vor 16 Stunden
Eastern Switzerland Cytokinetics VollzeitCytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of...
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Senior Manager Regulatory Affairs CMC, EMEA
vor 16 Stunden
Eastern Switzerland Ultragenyx Pharmaceutical VollzeitWhy Join Us?Be a hero for our rare disease patientsAt Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go –...
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Director – Quality GMP Small Molecules
vor 16 Stunden
Eastern Switzerland Monte Rosa Therapeutics VollzeitOverviewMonte Rosa Therapeutics. looking for a Director Quality GMP with quality expertise to support all GMP/GDP quality aspects of externally produced supply of drug substance and drug product for novel molecular glue degrader (MGD) programs, making a difference for our patients every day. Responsible for oversight of phase-appropriate Monte Rosa Quality...
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Senior Director, Clinical Scientist
vor 16 Stunden
Switzerland Summit Therapeutics, Inc. VollzeitOverview Of RoleThe Senior Director, Clinical Scientist is responsible for leading/contributing to study design and execution of clinical studies in hematology/oncology. As a leader within the clinical organization, this individual will be partnering with clinical operations, translational, and other matrix team members to design and refine clinical plans,...
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Director, Nautical Operations Marine
vor 3 Wochen
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SPM Group Lead
vor 16 Stunden
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Basel, Switzerland; United Arab Emirates; United Kingdom - Remote Ultragenyx Pharmaceutical VollzeitWhy Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't...
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Associate Director, Distribution Quality
vor 16 Stunden
Switzerland BeiGene VollzeitBeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General Description: This position reports to the...
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Regional Clinical Compliance Director/Senior Director
vor 16 Stunden
Switzerland BeiGene VollzeitBeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General Description:The Regional Clinical Compliance...
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Director, Hotel Operations
vor 3 Wochen
Switzerland Royal Caribbean Group VollzeitJourney with us! Combine your career goals and sense of adventure by joining our incredible team of employees at Royal Caribbean Group. We are proud to offer a competitive compensation and benefits package, and excellent career development opportunities, each offering unique ways to explore the world. We are proud to be the vacation-industry leader with...
