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PLEASE READ: these jobs are testing jobs of Lever's testing environment - please do not apply for this job.

Lever was founded ten years ago to tackle the most strategic challenge that companies face: how to recruit and hire top talent. We’re building the next generation of hiring software that companies like Netflix, Yelp, Cirque du Soleil, Shopify, and Spotify rely on to grow their teams. We've rethought the talent acquisition paradigm and are the innovation leaders in our space and looking for the right people to join us as we scale. We’re extraordinarily proud of the company we’ve built so far (not to mention humbled to be recognized as the #1 place to work in San Francisco, as well as a top workplace in the entire United States). Our people are Lever’s biggest competitive advantage and we’ll continue investing in our “Leveroos” and people-first culture. 

The Director/Senior Director, Regulatory Affairs, is a regulatory leader with expert technical and tactical experience in regulatory strategy and will be responsible for overseeing the development and implementation of global regulatory strategies for development programs, in line with business objectives and in coordination with key stakeholders

The incumbent will play a major role in shaping cohesive regulatory strategy across the product portfolio and ensuring effective integration of broad regulatory ideas/tactics supporting corporate goals and product development strategies. Externally, this individual will interface with regulatory authorities and business partners regarding program development and registration strategies. This role will understand and translate regulatory, scientific, operational, and business knowledge into effective implementation plans and strategy.

Primary Job Responsibilities

• Serve as key regulatory team member with responsibility for providing strategic and operational regulatory direction and support on projects including, but not limited to, overall regulatory strategies, regulatory requirements for clinical studies, regulatory strategic development plans and risk assessments, critical issue management and leadership of health authority interactions.
• Provide regulatory guidance and strategy for support of product development and registration strategies, including broad regulatory oversight for nonclinical/clinical development
• Ensure high-quality and timely regulatory submissions (IND/CTA/NDA/MAA, as applicable) in compliance with all applicable regulatory requirements, and in alignment with corporate goals
• Act as the primary liaison with regulatory authorities
• Direct and assist internal staff and regulatory consultants, as required, to ensure compliance of drug development activities with global requirements
• Support due diligence and partnering activities, as needed
• Analyze and communicate current regulatory guidance and regulations, as well as industry and regulatory agency best practices and trends, to keep company informed on any relevant changes in the regulatory landscape
• Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise
• Responsible for assisting with the development and implementation of regulatory processes
• Recruits, develops, manages, and mentors regulatory professionals and helps create a supportive and growth-minded culture
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations

THE LEVER STORY

Lever builds modern recruiting software for teams to source, interview, and hire top talent. Our team strives to set a new bar for enterprise software with modern, well-designed, real-time apps. We participated in Y Combinator in summer 2012, and since then have reached our Series D, raising more than $120 million. As the applicant tracking system of choice for Netflix, Atlassian, KPMG, and McGraw-Hill Education, and thousands more leading companies, Lever means you hire the best by hiring together.

Lever is an equal opportunity employer. We are committed to providing reasonable accommodations and will work with you to meet your needs. If you are a person with a disability and require assistance during the application process, please don’t hesitate to reach out! We celebrate our inclusive work environment and welcome members of all backgrounds and perspectives. Learn more about our team culture and commitment to diversity and inclusion. 

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