Structure Therapeutics
Senior Director, Regulatory Affairs
Structure Therapeutics, South San Francisco, California, us, 94083
Structure Therapeutics develops life-changing medicines for patients using advanced structure-based and computational drug discovery technology. The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical-stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.
Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company has completed an initial public offering (IPO) in February of 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location. #LIHybrid
Position:
The Senior Director, Regulatory Affairs is a key leadership position responsible for developing and executing regulatory strategies and operations necessary to guide the company's products through development, approval, and post-approval phases. The position will lead the development of regulatory documentation and direct regulatory interactions with global authorities for all development programs as well as initial regulatory efforts on pipeline programs.
Reporting to SVP, Regulatory Affairs and Quality Assurance, the role requires a seasoned regulatory professional with a deep understanding of the biotechnology industry, a proven track record of successful regulatory submissions, and the ability to lead a high-performing team. This will be an individual contributor role. This is a hybrid role that will require 3 days in the office (2 core days, 1 flex day).
Essential Duties and responsibilities:
Accountable for regulatory strategy and providing regulatory guidance to cross-functional teams and functional areas for project(s) assigned, i.e. from product/indication nomination through early to late-stage clinical development.Ensure clinical programs are developed and implemented in compliance with regulatory requirements. Provide relevant regulatory support.Plan and manage preparation and filing of global regulatory submissions (clinical, nonclinical, CMC) for assigned product(s)/program(s) including US IND as well as expedited programs such as Fast Track, Breakthrough, Orphan Drug Designation. Collect and collate data required for regulatory submissions.Interpret and explain global regulatory agency communications to cross-functional teams and functional areas to ensure accurate functional area responses to agency requests and comments.Stay current on changing regulatory environment and industry-standard expectations, advise cross-functional teams and functional areas on new and changing regulations and guidance that may impact ongoing development programs.Provide regulatory support to functional areas as they implement new or changed operating procedures for ongoing programs.Develops and manages a functional budget and maintains it within financial goals; reviews and approves invoices against approved budget.Lead regulatory input into preparing standalone clinical documents such as investigator's brochures, clinical study protocols, patient-informed consent forms, and clinical study reports.Ensure regulatory submission documents and correspondence are of the highest quality in content, organization, clarity of writing, and accuracy; ensure submission-readiness of all regulatory documents related to the project.Develops systems and processes for regulatory operations, collaborating with vendors as needed, to assure compliant, scientifically valid submissions, globally.Manages and maintains all regulatory submissions, archives, and requirements.Support the implementation of a Quality Management System, working with relevant functional lines to ensure delivery of documents for regulatory submission.Prepare status reports, conduct meetings to follow-up issues.Collaborate directly with external vendors for all stand-alone document publishing needs and publishing and compilation of eCTD submissions.Other duties as assigned.Core Competencies, Knowledge, and Skill Requirements:
Good knowledge and understanding of ICH, GMP, GCP and GLP guidelines. Support functional lines to ensure regulatory operations activities comply with regulatory expectations.Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.Ability to thrive in a fast-paced, entrepreneurial environment with busy, high performing colleagues.Ability to function at a high level in a team setting, adapting to changing environment as needed.Ability to proactively identify risks and provide risk mitigation efforts.Recognized by former colleagues, customers, managers, and/or direct reports for attributes congruent with Structure TX values. Excitement about the vision and mission of Structure TX.Ability to comprehend a situation by breaking it down into its components and identifying key or underlying complex issues.Systematically organizes and compares the various aspects of a problem or situation and determines cause-and-effect relationships and able to define and summarize actionable recommendations.Dedication to enabling translation of preclinical research into impactful human therapies.Ability to understand the audience needs across all forms of communication (phone, in-person, email, and documents) and to convey the information concisely and in an engaging manner.Self-motivation to initiate strategic independent and collaborative work assignment(s); raises hand to assist coworkers proactively.Able to reprioritize as competing interests arise and to operate successfully in an environment with a developing structure.Strong commitment to ensure quality and timely deliverables while maintaining and building relationships with coworkers, managers, vendors, and clients.REQUIREMENTS:
Education
BA or BS in a scientific discipline required. PhD or PharmD strongly preferred.Experience
10-12+ years of experience in regulatory affairs within the biotech or pharmaceutical industry, including direct experience interacting with the US FDATravel
Up to 10-20%
The target salary range for this full-time role is $250,000 to $300,000 + bonus + equity + benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education, and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.
Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company has completed an initial public offering (IPO) in February of 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location. #LIHybrid
Position:
The Senior Director, Regulatory Affairs is a key leadership position responsible for developing and executing regulatory strategies and operations necessary to guide the company's products through development, approval, and post-approval phases. The position will lead the development of regulatory documentation and direct regulatory interactions with global authorities for all development programs as well as initial regulatory efforts on pipeline programs.
Reporting to SVP, Regulatory Affairs and Quality Assurance, the role requires a seasoned regulatory professional with a deep understanding of the biotechnology industry, a proven track record of successful regulatory submissions, and the ability to lead a high-performing team. This will be an individual contributor role. This is a hybrid role that will require 3 days in the office (2 core days, 1 flex day).
Essential Duties and responsibilities:
Accountable for regulatory strategy and providing regulatory guidance to cross-functional teams and functional areas for project(s) assigned, i.e. from product/indication nomination through early to late-stage clinical development.Ensure clinical programs are developed and implemented in compliance with regulatory requirements. Provide relevant regulatory support.Plan and manage preparation and filing of global regulatory submissions (clinical, nonclinical, CMC) for assigned product(s)/program(s) including US IND as well as expedited programs such as Fast Track, Breakthrough, Orphan Drug Designation. Collect and collate data required for regulatory submissions.Interpret and explain global regulatory agency communications to cross-functional teams and functional areas to ensure accurate functional area responses to agency requests and comments.Stay current on changing regulatory environment and industry-standard expectations, advise cross-functional teams and functional areas on new and changing regulations and guidance that may impact ongoing development programs.Provide regulatory support to functional areas as they implement new or changed operating procedures for ongoing programs.Develops and manages a functional budget and maintains it within financial goals; reviews and approves invoices against approved budget.Lead regulatory input into preparing standalone clinical documents such as investigator's brochures, clinical study protocols, patient-informed consent forms, and clinical study reports.Ensure regulatory submission documents and correspondence are of the highest quality in content, organization, clarity of writing, and accuracy; ensure submission-readiness of all regulatory documents related to the project.Develops systems and processes for regulatory operations, collaborating with vendors as needed, to assure compliant, scientifically valid submissions, globally.Manages and maintains all regulatory submissions, archives, and requirements.Support the implementation of a Quality Management System, working with relevant functional lines to ensure delivery of documents for regulatory submission.Prepare status reports, conduct meetings to follow-up issues.Collaborate directly with external vendors for all stand-alone document publishing needs and publishing and compilation of eCTD submissions.Other duties as assigned.Core Competencies, Knowledge, and Skill Requirements:
Good knowledge and understanding of ICH, GMP, GCP and GLP guidelines. Support functional lines to ensure regulatory operations activities comply with regulatory expectations.Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.Ability to thrive in a fast-paced, entrepreneurial environment with busy, high performing colleagues.Ability to function at a high level in a team setting, adapting to changing environment as needed.Ability to proactively identify risks and provide risk mitigation efforts.Recognized by former colleagues, customers, managers, and/or direct reports for attributes congruent with Structure TX values. Excitement about the vision and mission of Structure TX.Ability to comprehend a situation by breaking it down into its components and identifying key or underlying complex issues.Systematically organizes and compares the various aspects of a problem or situation and determines cause-and-effect relationships and able to define and summarize actionable recommendations.Dedication to enabling translation of preclinical research into impactful human therapies.Ability to understand the audience needs across all forms of communication (phone, in-person, email, and documents) and to convey the information concisely and in an engaging manner.Self-motivation to initiate strategic independent and collaborative work assignment(s); raises hand to assist coworkers proactively.Able to reprioritize as competing interests arise and to operate successfully in an environment with a developing structure.Strong commitment to ensure quality and timely deliverables while maintaining and building relationships with coworkers, managers, vendors, and clients.REQUIREMENTS:
Education
BA or BS in a scientific discipline required. PhD or PharmD strongly preferred.Experience
10-12+ years of experience in regulatory affairs within the biotech or pharmaceutical industry, including direct experience interacting with the US FDATravel
Up to 10-20%
The target salary range for this full-time role is $250,000 to $300,000 + bonus + equity + benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education, and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.