The VP of Regulatory Affairs develops and implements regulatory and related strategies to gain regulatory approval in the US and global markets for the development and commercialization of BLADE Therapeutics’ products. Ensures adequate planning and accurate regulatory submissions for the earliest possible approvals of products, taking into account both U.S. and international regulatory requirements.
Strategic management and communication of regulatory strategy to internal and external stakeholders (FDA, EMEA, and TGA).
Coordinates and ensures internal/external resources are appropriate to ensure quality and timeliness of global regulatory submissions.
Assists in the selection and early development of programs by developing regulatory strategies and identifying regulatory regulatory risks.
Responsible for ensuring Regulatory Affairs has resources (staffing and facilities) to maintain documentation and forecasts future staffing requirements.
Ensures internal and/or external resources are adequate to provide Regulatory Affairs support for company projects. Interacts with senior level regulatory personnel at external partner companies, contract manufacturers and regulatory agencies.
Ensures resources are identified to support short- and long-term corporate goals and communicates impacts to Project Management/Managers and senior management.
Evaluates industry organizations and governmental agency initiatives and prepares company responses.
Resolves significant conflicts and disputes within and/or across departments. Negotiates win/win scenarios for organizational productivity and efficiency.
Reviews and manages overall departmental activities, ensuring alignment with company project timelines.
Manages departmental budget to plan, communicating major deviations and impacts to senior management.
Forecasts the most efficient use of internal and external staffing resources to ensure appropriate program/project regulatory support.
Provides input to R&D department activities, including but not limited to; Regulatory Affairs staffing requirements, budget proposal and tracking, regulatory SOPs, training requirements, improvements in operational efficiencies, etc.
Provides regulatory opinion and guidance reflecting Regulatory Affairs department practice/philosophy/policy to executive management.
Strategic thinker with ability to drive regulatory vision and communicate it to board and senior team.
Comfortable leading and building a small team.
History of success at developing and managing electronic investigational new drug applications with FDA (CDER); focus in hepatology, pulmonary, and cardiovascular therapeutic areas a plus.
History of successful completion of special protocol assessments, orphan drug designations, and fast track designation processes.
Experience with new drug applications [505(b)(1) and 505(b)(2)] and drug master files and demonstrated success at managing processes with EMEA.
Demonstrated experience and ability to successfully interact and negotiate with senior FDA/EMA/International Regulatory Agency reviewers on IND/CTA issues including but not limited to Pre-IND, FDA Types A-C, End of Phase II, and Pre-NDA Meetings with CDER.
Superior managerial skills including management of global teams and external vendors/partners.
Broad experience in regulatory disciplines (i.e., CMC, quality, preclinical, clinical, labeling, etc.) including oversight of GCP Compliance.
Experienced at developing regulatory department policies and procedures including the establishment of SOPs, templates, databases, and electronic publishing systems.
Excellent leadership and organizational skills, written and verbal communication skills, and interpersonal skills are required; must be able to effectively use these skills to influence many diverse internal and external customer groups at various levels within organizations.
Must be experienced in staff and organizational development, motivating personnel/teams, and providing effective coaching, training and development.
Must be detailed oriented, self-driven and goal-oriented, and able to multi-task to achieve results.
Must be able to adhere to strict project timelines and budgets, and to helm and advise teams and management of impacts and changes in project time-lines.
Ability to manage changing priorities, evaluate impact, and communicate timeline and resource impacts to project teams and management is required.
Up to 15% travel may be required
Additional Salary Information: An attractive compensation package commensurate with this senior leadership role will be provided.
Internal Number: 001
About Blade Therapeutics
Blade Therapeutics is advancing novel anti-fibrotic therapies to meet important patient needs in an area that has seen little innovation to date. Several rare/orphan and chronic debilitating conditions manifest as a consequence of fibrosis, a complex, pathologic process in which progressive scarring replaces functional tissue. We are seeking to develop therapies to modify disease progression, and in some cases, potentially reverse the fibrotic damage to tissue.
Blade is advancing a risk-diversified product portfolio to address various fibrotic diseases and their underlying pathophysiology. The Company has assembled a critical mass of fibrosis expertise and a top-tier leadership team and world-class network of advisors with unparalleled experience in anti-fibrotic drug R&D. Blade’s founding programs are based on the discoveries of Hal Dietz, M.D., Victor A. McKusick Professor of Genetics and Medicine, Johns Hopkins University, whose pioneering research has elucidated a biological pathway that is enabling the discovery of small molecules to treat and potentially reverse fibrosis.
Blade’s objective is to be the leading anti-fibrotic company with a pipeline of novel therapies designed to address the unmet needs for innovative treatments to treat various fibrotic conditions.