Head of International Regulatory Affairs

Head of International Regulatory Affairs

Role Overview:

The primary responsibility of this role is to develop and implement regulatory strategies for product development and registration in all relevant ex-North America (NA) markets in alignment with global corporate objectives.

Core Responsibilities:

• Serve as the primary liaison with regulatory authorities in all relevant ex-NA countries.
• Prepare for and lead Health Authority meetings as necessary.
• Oversee the preparation, review, and submission of all relevant regulatory filings in ex-NA regions, including ensuring timely responses to regulatory queries.
• Monitor evolving regulatory requirements across ex-NA regions and proactively communicate impacts and opportunities to internal stakeholders.
• Ensure high-quality regulatory documentation and contribute to establishing scalable regulatory processes and systems.
• Identify and implement processes and tools as needed for regulatory activities.
• Review and evaluate procedures according to relevant guidelines, standards and policies.
• Manage regional regulatory consultants and vendors.
• Represent regulatory affairs to vendors, business partners, regulatory bodies, and executive leadership with or in the absence of the EVP, Regulatory Affairs as required.
• Partner closely with Clinical Development, Medical Affairs, CMC, Quality, Commercial, and external consultants to align regulatory plans with business goals and timelines.
• Other duties and projects as assigned.

Key Qualifications:

• Bachelor's degree in a life science or health-related field required; advanced degree (PharmD, PhD, or MSc) preferred.
• 12+ years of experience in regulatory affairs within the pharma or biotech industries, with at least 8 years of experience in ex-NA regions.
• Proven track record leading investigational and marketing applications and major agency interactions; experience with complex marketing applications a strong plus.
• Familiarity with rare diseases strongly preferred.
• Ability to operate strategically while executing operationally in a lean, fast-paced environment.
• Exceptional communication, attention to detail, leadership, and project management skills.
• Proactivity and ability to work with minimal supervision.
• Ability to challenge the status quo and identify better ways to work and achieve goals.
• Strong quality compass.
• Ability to make judgements and decisions incorporating both regulatory judgement and business acumen.
• Fluency in English.

Work Schedule and Location:

This role will be remote within the United States. Occasional travel to the corporate office outside of Philadelphia, PA and as needed - travel to vendor locations domestically and internationally will be required. The employee must be able to work a US eastern time schedule.

Comprehensive Benefits:

• Medical, dental, and vision coverage.
• Flexible Spending Accounts for health care and dependent care expenses.
• Paid time off and paid holidays, including Dec 24-Jan 1.
• Paid parental leave.
• 401k with highly competitive match.
• Life, AD&D, STD and LTD insurance coverage.

Compensation:

Savara’s compensation can include a base salary, bonus, and equity. This role will be filled either at an Executive Director or Vice President level and the base salary range is $265,000 to $325,000.

About Savara

Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. The company's lead program, molgramostim nebulizer solution, is in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Savara's management team has extensive experience in rare respiratory diseases and pulmonary medicine, advancing product candidates to approval and commercialization.