Senior Director, International Regulatory Affairs at Denali Therapeutics

Zürich, Zurich, Switzerland

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, NeuroscienceIndustries

Requirements

Bachelor’s degree required; advanced degree in life sciences or related discipline strongly preferred
12+ years of regulatory affairs experience in the pharmaceutical or biotechnology industry
At least 8+ years in international regulatory affairs
Direct experience with major international regulatory agencies (e.g., EMA, PMDA, Health Canada, TGA, Swissmedic)
Demonstrated success in leading global submissions, including CTAs and MAAs
Demonstrated success in developing international regulatory strategies for early- to late-stage development

Responsibilities

Developing and implementing international regulatory strategies for clinical development and commercial-stage products across Denali’s global portfolio
Leading the planning, preparation, and submission of regulatory applications including Clinical Trial Applications (CTAs), Marketing Authorization Applications (MAAs), Orphan Drug Designations, and other key filings to Health Authorities outside the United States
Serving as the primary liaison with global Health Authorities (e.g., EMA, MHRA, PMDA, Health Canada), including leading preparation for and participation in scientific advice meetings and regulatory interactions
Collaborating with cross-functional teams to support timely initiation and maintenance of global clinical trials and product registrations
Monitoring global regulatory developments, assessing impact on programs, and translating requirements into clear regulatory strategies and recommendations
Ensuring the quality, consistency, and compliance of international regulatory submissions and communications
Leading the development and maintenance of internal processes and tools for global regulatory activities, including policies, templates, and training initiatives
Partnering with regional affiliates, CROs, and local consultants to execute submissions and maintain compliance with local requirements
Supporting global labeling strategies and alignment with U.S. labeling, where applicable
Mentoring, developing, and managing international regulatory team members, and fostering a culture of collaboration, innovation, and excellence
Leading direct report(s) through annual goal setting, growth planning, adherence to company policies, maintaining training compliance, and providing ongoing feedback on growth, development, and areas of improvement

Skills

Key technologies and capabilities for this role

Regulatory AffairsEMAPMDAClinical Trial ApplicationsMarketing Authorization ApplicationsCTAsGlobal Regulatory StrategyDrug DevelopmentHealth Authority InteractionsRegulatory Submissions

Questions & Answers

Common questions about this position

What is the employment type for this Senior Director role?

The position is full-time.

What are the key responsibilities of the Senior Director, International Regulatory Affairs?

The role involves developing international regulatory strategies, leading submissions like CTAs and MAAs to agencies such as EMA and PMDA, serving as liaison with global Health Authorities, collaborating cross-functionally, monitoring regulatory developments, ensuring compliance, and partnering with affiliates and CROs.

What skills and experience are required for this position?

Candidates need to be highly motivated strategic regulatory professionals with global expertise in drug development and regulatory submissions, strong technical and operational regulatory acumen, a global mindset, and passion for advancing therapies for neurodegenerative diseases.

Does this role involve managing a team?

Yes, the role will oversee a team of international regulatory professionals.

What is the company culture like at Denali Therapeutics?

Denali is founded on collaboration among leading scientists, industry experts, and investors, with a deep commitment to degeneration biology, translational medicine, and delivering effective therapies for neurodegenerative diseases.

Denali Therapeutics

Develops treatments for neurodegenerative diseases

About Denali Therapeutics

Denali Therapeutics focuses on finding and developing treatments for neurodegenerative diseases like Alzheimer's, Parkinson's, and ALS, which involve the gradual loss of nerve cells and can lead to serious physical and mental challenges. The company uses scientific research to understand the biological pathways that lead to these diseases, aiming to create drugs that target specific molecules in the body to treat them. Denali stands out from its competitors by combining its own research efforts with partnerships with other biotech firms and pharmaceutical companies, allowing it to share risks and access new technologies. The goal of Denali Therapeutics is to create effective treatments that improve the lives of patients suffering from these debilitating conditions.

South San Francisco, CaliforniaHeadquarters

2015Year Founded

$337.5MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Risks

Failure in ALS trials raises concerns about pipeline efficacy.

Increased competition in ALS treatment could impact market share.

Discontinuation of programs due to toxicities highlights potential development challenges.

Differentiation

Denali focuses on neurodegenerative diseases like Alzheimer's, Parkinson's, and ALS.

The company employs a science-driven approach to translational medicine and clinical development.

Denali leverages partnerships to access new technologies and spread financial risk.

Upsides

Denali's $500 million financing strengthens its financial position for pipeline advancement.

Partnership with Biogen could accelerate Parkinson's treatment development.

Focus on blood-brain barrier technology shows promise in treating lysosomal storage diseases.

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