Director/Senior Director, Regulatory Affairs
Alpine Immune Sciences is applying our platform discovery technology to bring innovative new therapies to people living with serious or life-threatening illnesses or conditions, such as cancer and autoimmune/inflammatory diseases. Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!
The Director/Senior Director, Regulatory Affairs reports to the Vice President of Regulatory Affairs and is responsible for contributing to Alpine’s global 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 senior management, 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.
Key Responsibilities:
- Serve as the global regulatory lead for select development programs.
- Provide strategic and operational input, guidance, and oversight to project development teams to assure that regulatory submissions and all aspects of regulatory compliance support R&D objectives.
- Serve as functional regulatory lead in health authority interactions, manage all correspondence with health authorities and the RA coordination with partner companies and vendors.
- Provide leadership and direction in the development of nonclinical and clinical regulatory documents including INDs, CTAs, BLAs, and MAAs. This may involve writing relevant sections of documents.
- Perform critical review of submission documents to ensure compliance with regulatory requirements.
- Create and maintain Regulatory Development plans and provide strategic input in product development planning.
- Identify and communicate to senior management about potential regulatory issues; propose risk mitigation strategies
- Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
- Leads continuous improvement efforts on existing department processes and strategies, providing recommendations in areas of expertise.
- Mentor and help develop the strategic and technical expertise of Regulatory colleagues within the Alpine organization.
Qualifications:
- BS/BA degree (or equivalent) in a relevant scientific field required, with an advanced degree preferred.
- 10+ years of experience working in a regulatory affairs function, in roles of increased responsibility, with at least 5 years’ experience in a management/supervisory role.
- 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 managing complex negotiations with Regulatory Authorities.
- Prior global regulatory experience required.
- Therapeutic area experience in autoimmune diseases is desired.
- Experience writing and developing SOPs.
- Demonstrated ability to: develop/maintain strong working relationships with cross-functional teams, participate on 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.
- Strong written and oral communication skills.
- Will work tirelessly to foster an environment of transparency and direct dialogue.
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.
We take care of our employees with competitive benefits package which includes premium medical, dental, and vision coverage for employees and their dependents, wellness programs, FSA and 401(k) plans. We believe that quality time outside the office is vital to our employees’ satisfaction at work. That’s why our flexible PTO plan encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).
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.
As a condition of employment, Alpine requires that employees are up to date with COVID-19 vaccination. In order to be considered up to date, employees must have completed a primary series of a SARS-CoV-2 vaccine, followed by a booster dose, as recommended by the CDC. Employees can submit requests for medical or religious exemption so that Alpine can consider possible accommodations.
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 during the COVID pandemic. 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!