Senior Vice President, Regulatory Affairs
Seattle, WA or Remote
Regulatory – Regulatory /
Full time /
Alpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!
The Sr. Vice President, Regulatory Affairs reports to the Chief Medical Officer and is responsible for contributing to the global company regulatory strategy and working closely with cross functional leaders in all regulatory interactions and activities for the development of Alpine’s therapeutic candidates. The position includes responsibility for the development and refinement of regulatory strategy working in collaboration with the executive team, to ensure compliance with applicable global regulations, standards, and clinical practice guidelines. This position is responsible for providing regulatory oversight for the management of clinical trial applications and filings, and will work closely with various partners, consultants, CROs, and local and global health authorities to ensure rapid review and approval of global clinical trial applications, and other applicable regulatory filings.
The Sr. Vice President, Regulatory Affairs is one of the most important positions at Alpine Immune Sciences. She/he must be able to provide sound strategic regulatory guidance, communicate clearly (in verbal and written form), and display exemplary organizational, regulatory and leadership skills, including team mentorship. In addition, the successful candidate will create a successful team culture and build the team over time to deliver exceptional results and ensure long-term success.
Duties and responsibilities
• Lead the development of regulatory strategies and objectives that result in the successful registration and post-approval commercialization of the company’s product candidates.
• Develop and implement operational plans to achieve internally approved regulatory objectives.
• Serve as primary regulatory agency contact at the FDA and directly or with contract regulatory support,withtheNMPA/CDE,EMA,PMDAandotheragenciestoachievecompanyregulatory objectives.
• Serve as key point of contact for managing and directing regulatory inspections.
• Keep peers and executives apprised of expected changes to the regulatory landscape affecting existing and future products and provide strategic and tactical direction to drive cross-functional consistency in regulatory approach and planning.
• Facilitate strategies for the approval of products across geographies either by Alpine Immune Sciences or its partners
• Developanddesignrobustregulatoryprocessesandprocedures,andbudgetforecastingbasedon expert understanding and experience.
• Partner with and support across Clinical Development, CMC, Quality, Project Management, Research and Discovery, Translational Medicine, Business Development, Safety/PV, Data Sciences and other areas including the review and submission of clinical protocols and regulatory documents, publications, investor relations/legal public disclosures.
• Provide Business Development with guidance and critical evaluation of potential product opportunities, in support of strategic partnering and licensing activities.
• Provide regulatory review and approval of product labeling, promotional claims, and advertising to ensure compliance with corporate policy, and US laws and regulations.
• Direct long and short-term regulatory departmental planning including structure, headcount, budgeting, training, and systems requirements.
• Manage internal regulatory procedures to ensure compliance.
• Manage external regulatory vendor and platform service team members and providers.
• Hire, onboard and manage regulatory professionals as the organization grows.
• Ability to travel to headquarters in Seattle and other business travela s needed.
• Other duties as assigned.
• Mentor and help develop the strategic and technical expertise of more junior Regulatory colleagues within the Alpine organization.
• BS/BA degree (or equivalent) in a relevant scientific field required, with an advanced degree preferred.
• 20 years of experience in biotechnology or pharmaceutical industry with hands on experience and knowledge of the drug development process and regulatory submission and approval process required.
• 15 years of experience working in a regulatory affairs function, in roles of increased responsibility.
• Strong vendor management experience.
• In-depth knowledge of FDA and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required.
• Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
• Prior global regulatory experience required.
• Therapeutic area experience in autoimmune diseases/inflammation/immunology is very much desired.
• Experience writing and developing SOPs.
• Demonstrated ability to: develop/maintain strong working relationships with cross-functional teams, participate in and/or lead multifunctional teams, handle and prioritize multiple projects and work independently.
• Detail-oriented while also retaining the ability to see the big picture.
• Flexible with demonstrated ability to work in a fast-paced, timeline-driven environment.
• Effective technical/analytical skills to identify and solve problems independently.
• Proven ability to manage multiple projects, identify and resolve regulatory issues as they arise.
• Proven ability to effectively collaborate with internal team and external collaborators.
• Will work tirelessly to foster an environment of transparency and direct dialogue.
At Alpine we engage equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. This position is a Professional level position up with a compensation range of $250,000 to $350,000. We take care of our employees with a competitive benefits package that includes stock options, annual bonus, premium medical, dental, and vision coverage for employees and their dependents, as well as life and disability benefits, FSA, and 401(k) plans. We believe quality time outside the office is vital to our employees’ satisfaction at work, so our flexible PTO plan of 160 hours, generous holiday time (generally 12 days), and parental benefits encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).
Alpinists share a passion for meaningful work and are committed to solving the most complex problems in immunology to create new therapies for patients. We believe in innovative thinking, collaboration, flexibility, bias for action, and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment with a state-of-the-art lab and office spaces with truly inspiring views, and an open design to facilitate teamwork.
Our treasured culture has been shaped by our diverse team who truly enjoys working and playing together. We nurture Alpine’s culture in many ways, including all-company social events and happy hours, lunch-and-learn and education opportunities, interest groups like book club and movie nights, peer-to-peer recognition programs, a robust wellness program to help support physical, mental, and emotional health, and more.
Alpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Our office and lab are located in the blossoming biotech neighborhood of Eastlake in Seattle. Alpinists enjoy the flexibility to work onsite, remotely, or a hybrid schedule, with evolving options as we prioritize keeping Alpinists safe and healthy. Onsite employees enjoy an open-office layout with comfortable huddle rooms and Zoom Room-enabled conference rooms, a spacious breakroom and kitchen with a coffee bar and snacks, and rooftop access to enjoy gorgeous views of Lake Union and Gas Works Park.
Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!