Senior Director/Executive Director, Regulatory Affairs ...

Description Please make sure you read the following details carefully before making any applications. Ventyx is a clinical-stage biopharmaceutical company focused on developing innovative oral medicines for patients living with autoimmune and inflammatory disorders. We believe our ability to efficiently discover and develop differentiated drug candidates will allow us to address important unmet medical needs with novel oral therapies that can shift inflammation and immunology markets from injectable to oral drugs. Our current pipeline includes internally discovered clinical programs targeting NLRP3, S1P1R and TYK2, positioning us to become a leader in the development of oral immunology therapies for peripheral and neuroinflammatory diseases. The Opportunity: Senior Director/Executive Director, Regulatory Affairs Strategy: The Senior Director / Executive Director, Regulatory Affairs will provide leadership in building a high performing global regulatory function for Ventyx Biosciences, Inc. This position reports to the SVP of Regulatory Affairs. What You Will Contribute: Provides breadth and depth of regulatory expertise and leadership to cross-functional product development teams. Participates as a standing member in various teams, dependent upon assigned projects and the associated programs, coordinates cross-functional contributions. Responsible to ensure all RA deliverables associated with each project or other assignment are completed within defined timelines and meet relevant regulatory and company guidelines. Oversees, coordinates, and delivers regulatory submissions and other relevant regulatory documentation. Serves as the primary RA representative on one or more global studies. Analyzes data, the regulatory environment, and business objectives to drive alignment on priorities. Directs, trains, and guides internal teams on interactions with regulatory authorities. Develops and drives regulatory risk management and contingency plans. Communicates plans to management, as appropriate. Provide strategic direction on current pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities. Additional duties assigned as needed. What We Seek: 14+ years of relevant experience in regulatory affairs or related functions in drug development BS/BA degree in life sciences discipline or highly related field required, advanced degree preferred Broad understanding of international regulations, processes, and issues in drug development Experience as a regulatory contributor for IND/CTA, NDA/MAA filings Confident and competent when interacting with varying levels of internal/external management, raises issues or challenges in a productive and mature manner, building strong positive relationships Strong negotiation skills: can effectively drive discussions and decisions toward desired end-results Strong writing skills with extremely high attention to detail Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target accomplishment Strong interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally Proven track record of effective decision-making: makes good business decisions and exercises sound judgment. Consistently and effectively balances decisions with imperatives for ethics and efficacy Broad and current knowledge of ICH, GCP, IRB/IEC and local regulatory authority drug research & development regulations Motivated to work in a fast-paced, high accountability environment Demonstrated agility to learn, and prioritize multiple responsibilities independently, remove barriers and drive projects to completion Ability to strike a balance between independent work and team interaction, be a team player in a cross-functional team Proficiency in Microsoft Office and other productivity tools with an aptitude to learn new software and systems What We Provide to You: The opportunity to make a difference in people's lives impacted by autoimmune and inflammatory diseases. Participate in a team of life science professionals who value science, data, high work ethic and a meritocracy; access to all levels of the organization to get work done with a sense of urgency. Competitive compensation and a comprehensive benefit package, including stock options. The anticipated annual base salary range for this role is $260,000 - $310,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, company needs, and market factors. Ventyx is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, LTD, time off, a retirement plan, and other voluntary benefits for employees. Ventyx is an equal opportunity employer and strives to maintain a work environment in which all individuals are treated with respect and dignity. Qualified applicants will receive consideration for employment without regard to race, age, ethnicity or national origin, color, religion, sex (including pregnancy, childbirth, breastfeeding or related medical conditions), gender identity, sexual orientation, disability or medical condition (including genetic information or characteristics or those of a family member), military service or veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations. #J-18808-Ljbffr

Created: 2025-01-01