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Sr. Director, Regulatory Operations - South San Francisco, United States - Structure Therapeutics
Description
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.
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.
Position Summary
The Senior Director of Regulatory Operations will be responsible for carrying out the planning, scheduling, and coordination of submission obligations, in collaboration with Regulatory colleagues, those from other functional areas, and outside vendors.
Director of Regulatory Operations owns the interface between Regulatory Operations vendors, including definition, planning, implementation of the collaboration, as well as day-to-day vendor oversight and budget management.
In addition, the Senior Director of Regulatory Operations is expected to share his/her knowledge and experience with other functional areas as well, in the spirit of continuous improvement.
Essential Duties and responsibilities
Manage assigned projects and closely collaborate with personnel from the Regulatory and other departments (as with vendors), to coordinate and implement high quality submission output.
Using project management and planning tools as required, work to ensure assembly of all submissions are planned, coordinated, and delivered on time, and adhere to company and agency standards.
Identify appropriate resources/business strategies needed to support submission publishing activities.Collaborate as a member of project teams, meeting regularly to identify and resolve open issues and to assess quality, delivery, and effectiveness, while developing opportunities for regulatory submission process improvement.
Maintain the submission-tracking process in support of short and long-term submission and resource planning.Maintain the company's Regulatory Archive up-to-date and Diligence ready.
Initiate, author and/or collaborate on Standard Operating Procedures, Work Instructions, and Workflows for the Regulatory Operations function; ensure that Company's practices are in conformance with the latest health authority and industry submission standards
Manage the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents to ensure that said documents meet requirements as 'Approved for Submission'
Proactively plan for short-, mid- and long-term Regulatory Operations resources, and strategically plan for a fit-for-purpose team that will grow with the Company
Interact and/or negotiate with the FDA and other regulatory agency in interpreting and implementing electronic standards related to eCTD and other submission formats.
Source, manage and disseminate Regulatory Guidance pertinent to submission standard cross-functionallyPerform other related duties as assigned activities.
REQUIREMENTS
Education
Minimum bachelor's degree in Life Sciences or relevant field. Masters or equivalent is a plus.
Experience
10 to 12+ years' experience working in a regulated, life science environment (pharmaceutical, biotechnology, consumer health)
Advanced working knowledge of eCTD publishing systems, and relevant publishing tools.
Extensive knowledge of North American/Global submission standards (FDA, Health Canada, PMDA, CDE, EMA, ICH, GXP, eCTD, etc.), and industry trends for dossier preparation (i.e.
IND/CTA/NDA/MAA/NDS).Significant track record in leading regulatory operations staff through major global submissions (NDA, MAA etc)
Proven experience in selection, implementation and use of the appropriate Regulatory Operations systems, vendors, and procedures.
Demonstrated experience in project management and a clear understanding of US and ex-US requirements regarding submission content and format. The ability to multitask and manage multiple and changing priorities. A proven ability to work under pressure and adhere to deadlines
Computer proficiency in Microsoft Office, including Word, Excel, PowerPoint, Project, and Documentum technology.
Self-motivated, flexible, and creative leader, able to prioritize, multi-task and work in a fast-paced and demanding environment
Superior communication skills:
oral, written, with proven negotiation skills, and strong time-management. A critical and logical thinker with the ability to analyze problems, identify alternative solutions and implement recommendations for resolution.
Sound understanding of information management concepts and tools needed to carry-out Regulatory Operations priorities, and a practical understanding of evolving technologies in support of all business areas.
Advanced knowledge of pharmaceutical development (CMC, Nonclinical, Clinical research), with the ability to understand and interpret data/information and its practical application.
Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
Experience working with external vendorsNDA submission experience in a supportive role required, in a lead role preferred
Travel
10-20%
The target salary range for this full-time role is $250,000 - $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.
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Sr. Director, Regulatory Operations professionals in South San Francisco
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