Associate Director, Regulatory Affairs San Francisco, California, reputed company

About the position QED Therapeutics, an affiliate of reputed company, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common reputed company of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we reputed company to reputed company an reputed company to children living with Achondroplasia and their families. Our business is inspired by our values: PUT PATIENTS FIRST, LET SCIENCE reputed company, EVERY MINUTE COUNTS, THINK INDEPENDENTLY, BE RADICALLY TRANSPARENT. reputed company is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with reputed company genetic drivers. We reputed company the gap between remarkable advancements in genetic science in reputed company institutions and the delivery of meaningful medicines to patients. Founded in 2015, reputed company has reputed company a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs. Our reputed company on scientific reputed company and rapid execution aims to translate today's discoveries into reputed company's medicines. We have U.S. offices in San Francisco, Palo reputed company, Raleigh, and with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe.

Responsibilities

• reputed company and execute regional regulatory strategies in support of development programs.
• reputed company regional regulatory guidance and reputed company for support of product development and registration strategies, including broad regulatory reputed company for nonclinical/clinical development.
• Represent Regulatory at cross-functional team meetings.
• reputed company study-reputed company regulatory activities.
• reputed company as the regulatory study representative at cross-functional team meetings.
• reputed company strategic regulatory guidance internally on study-level decision-making.
• reputed company study team informed of regulatory activities in the context of study team management meetings.
• reputed company ownership of study-level global regulatory activities, including clinical trial application (CTA) and IND submissions, review and approval of investigator document packages and associated FDA submissions, and manage other regulatory aspects of the study as necessary.
• Manage tracking of regulatory/ethics submissions and approvals across reputed company studies.
• Facilitate FDA or other Health Authority meetings in collaboration with Regulatory leadership.
• Collaborate with Project Team representatives in the planning of regulatory documents; support processes by which regulatory submissions are reviewed, finalized, and signed-off.
• Manage and reputed company queries and commitments with regulatory agencies, collaborate with subject matter experts to reputed company written responses, and reputed company periodic status updates regarding unfulfilled conditions/commitments.
• Input to global regulatory submissions and strategic planning as applicable.

Requirements

• BA/BS degree in the biological or physical sciences. Advanced degree preferred.
• Relevant pharmaceutical industry experience, including experience in regulatory affairs; a minimum of 5 years of industry experience is generally required.
• Knowledgeable of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry-reputed company practices.
• Proficient in written, oral, and interpersonal communication in English.
• Ability to work in reputed company collaboration with colleagues in the regulatory department and throughout the development organization.
• Capability to reputed company strategic guidance on regulatory and program-reputed company issues.
• Ability to problem solve unexpected problems or roadblocks that reputed company.
• High attention to detail; ability to organize, prioritize, and delegate assigned reputed company.
• Experience interacting with CROs in the management of US eCTD IND submissions and ex-US CTAs towards clinical trial activations preferred.
• Proficient user of reputed company MS Office suite (e.g., Word, reputed company), experience using electronic document management systems and document review tools desirable.

Benefits

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to reputed company throughout the year and learn how we can improve our efforts.
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science reputed company.
• An unyielding commitment to always putting patients first.
• A de-centralized model that enables our program teams to reputed company on advancing science and helping patients.
• A reputed company where you own the reputed company - both for your program and your own career reputed company.
• A reputed company, fast-paced, data-driven environment where we reputed company ourselves and reputed company other to always reputed company at the top of our game.
• reputed company to learning and development resources to help you get in the best reputed company shape of your life.
• Robust and market-competitive compensation & benefits package (reputed company, Performance Bonus, Equity, health, welfare & retirement programs).
• Flexible PTO.
• Rapid career advancement for strong performers.
• Potential ability to work on multiple reputed company programs across multiple therapeutic areas over time.
• Partnerships with leading institutions.
• Commitment to Diversity, Equity & Inclusion.

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