ARAVAS INC

Compensation

Full Description

Note: we will begin interviewing for this role in January Role Description The Executive Director/VP Regulatory Affairs will work closely with the EVP of Regulatory affairs to drive all regulatory activities and create regulatory strategies related to all projects of the Company globally. This includes planning and support for all global regulatory activities, contact with regulatory bodies, and supervision of internal regulatory affairs staffs and external regulatory consultants. Regulatory Affairs will have regulatory leadership responsibility for the drug development pipeline projects through development phases and milestones and will oversee commercial drug regulatory requirements including support for the regulatory elements of MLR. The candidate will also help provide regulatory advice to Clinical Development, Clinical Operations, Chemistry and Manufacturing, Compliance and Quality, and Non-Clinical and other groups to ensure compliance with regulatory processes and regulatory requirements for various regulatory bodies around the world. This role can be filled either within the US or in Copenhagen, Denmark and at either an Executive Director or Vice President level. Core Responsibilities • Creates regulatory strategies, including timelines relevant to drive the development of all company products and projects in support of the EVP of Regulatory • Maintains contacts with relevant regulatory authorities • Oversees filing of all regulatory applications complying to the requirements of all regulatory bodies around the world in conjunction with the EVP of Regulatory • Responsible for contributing to the overseeing outsourced regulatory activities, including activities delegated to partner contract research organizations (CROs) or contract manufacturing (CDMOs) • Responsible for maintaining, updating, and staying compliant with all regulatory designations, such as orphan designation, breakthrough designation, fast-track designation, priority review designation, etc. • Provides input and supports Clinical Development, Clinical Operations, Global Technical Operations and Quality, and will work with these disciplines in a collaborative fashion • May serves as the regulatory lead of Company project teams and sub-teams as required • Serve as the co-lead with regulatory authorities in all relevant ex-NA countries. • 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. • Represent regulatory affairs to vendors, business partners, regulatory bodies, and executive leadership with or in the absence of the EVP, Regulatory Affairs as required. • Provide regulatory advice to multidisciplinary teams on the regulatory requirements to support clinical and nonclinical development, including preparation and maintenance of IND and CTA fillings • Ensure the company adheres to all regulatory requirements and policies • Responsible for regulatory commercial preparation, and Regulatory oversight of commercial activities including maintaining compliance with all filing requirements and promotional requirements • Monitor regulatory “intelligence” to stay up to date with policy changes, policy trends and actions as they might apply to Savara 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 5 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. • 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 • Knowledge of global regulatory legislations and guidelines and global regulatory systems for tracking and management of filings • Scientific understanding and knowledge involving the development of biologic products, small molecule products and drug-device combination products. Experience in respiratory disease drug development is desirable. • Specific training and certification in Regulatory Affairs are desirable • Ability to independently work with minimal supervision in a multi-disciplinary environment in a disciplined and structured way • Personal Attributes: high energy and passion for getting things done; abilities to build and maintain highly collaborative relationships; attention to details and analytical mindset; team player with a “we” mentality; ability to make judgement and decisions incorporating scientific matters and regulatory requirements in a data driven and pragmatic way Work Location and Travel This role can be filled either remotely within the US or in Copenhagen, Denmark and requires the ability to regularly attend meetings in a US Eastern Time Zone. Travel to Savara's US HQ outside of Philadelphia is required; other travel (including international) to vendor locations will be required. Compensation and Benefits Savara's approach is to provide comprehensive compensation and benefits that are competitive within the job market, offer opportunities to recognize excellence in performance, and are equitable and accessible for all staff. The compensation package for this role will include a base, bonus and equity in all locations. Within the US, the base range for this role is $275,000 to $335,000 and will be filled at either an Executive Director or Vice President level. Savara provides comprehensive US benefits including: • Medical, dental and vision coverage • FSA for health and dependent care and HSA • Paid time off and paid holidays, including a week-long winter shutdown • Paid parental leave • 401(k) with highly competitive match • Life, AD&D, STD and LTD insurance coverage 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.