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Head of Regulatory Affairs

1 month ago

minnetonka, United States DiaMedica Therapeutics Inc. Full time

DiaMedica Therapeutics:

DiaMedica Therapeutics Inc. is a well-funded, clinical stage biopharmaceutical company committed to improving the lives of people suffering from serious ischemic diseases with a focus on acute ischemic stroke and preeclampsia. DiaMedica’s lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein. DM199 is currently in development for acute ischemic stroke and preeclampsia. KLK1 is a serine protease enzyme that plays an important role in the regulation of diverse physiological processes via a molecular mechanism that increases production of nitric oxide, prostacyclin and endothelium-derived hyperpolarizing factor. In the case of acute ischemic stroke, DM199 is intended to enhance blood flow and boost neuronal survival in the ischemic penumbra by dilating arterioles surrounding the site of the vascular occlusion and inhibition of apoptosis (neuronal cell death) while also facilitating neuronal remodeling through the promotion of angiogenesis. In preeclampsia, DM199 is intended to lower maternal blood pressure, enhance endothelial health and improve perfusion to maternal organs and the placenta.

 

POSITION SUMMARY:

Reporting to the Chief Medical Officer, the Head of Regulatory Affairs will develop, lead, and drive the execution of DiaMedica’s regulatory strategy through regulatory approval to commercialization and product lifecycle management. This person will be the senior lead for all regulatory functions with responsibility for regulatory strategy, filings, communications, and negotiations for the company.


KEY ACCOUNTABILITIES:

•Build and lead the global regulatory strategy and function

•Responsible for directing innovative global regulatory strategies for product development and approval

•Build relationships and partnerships with vendors (including CROs), licensors, and joint development collaborators, aligning on regulatory strategies, deliverables, and goals; this includes the selection and direction of regulatory consultant(s), as required, to ensure the compliance of DiaMedica’s drug development activities with all US and international requirements

•Key focus on clinical regulatory strategy and regulatory path opportunities, and direct oversight of regulatory requirements/strategy for other critical activities such as CMC

•Plan, oversee, and execute activities in support of INDs, NDAs, BLAs, MAAs, CTAs and other regulatory submissions, including owning submission timelines, understanding, and strategizing scientific content from functional leads for the regulatory submission content

•Serve as the primary contact with major health authorities and liaise directly with FDA and other global regulatory agencies, including the preparation for and leading of agency meetings

•Provide regulatory guidance to company personnel and project teams in all areas of regulatory affairs

•Develop and monitor product regulatory plans including oversight of implementation of the project plan, risk identification and mitigation across clinical, pre-clinical and CMC departments

•Decision making and contingency-planning and/or course-correction on issues that could delay project schedules or activities, communicating issues/risks to key stakeholders in a timely and consistent manner, and monitoring both functional and project performance against goals

•Critically evaluate documents submitted to regulatory agencies to ensure that they are complete, well organized, scientifically accurate, of high-quality, in compliance, and presented in a way that facilitates agency review and fulfills strategic goals and objectives

•Identify and execute regulatory pathways that facilitate rapid regulatory review and product exclusivity timelines such as Priority Review and Orphan Drug Designation

•Monitor current and proposed regulatory issues and trends and advise management on events of significance for DiaMedica’s business interests

•Identify and implement processes, procedures (including SOPs as appropriate), and solutions for optimization and efficiency commensurate with departmental growth

•Perform all duties in keeping with the company’s core values, policies, and all applicable regulations


QUALIFICATIONS:

•Bachelor of Science degree, preferably in a life science field; Master of Science or other advanced degree preferred

•10+ years’ regulatory strategy and operations, managing programs across multiple phases in the life science industry, ideally including 5+ years recently on neurology drug development programs

•Substantial number of years successfully working with the FDA, utilizing novel regulatory pathways, and applying creative approaches during negotiations

•Experience with biologics and protein therapeutics is highly preferred, and experience utilizing and working with CMC regulatory consultants is preferred as well; in particular, an understanding of the CMC process, drug administration, safety profile

•Knowledge and broad experience with regulatory procedures and regulations in multiple regions, including the US, EU, and other major health authorities

•Extensive experience leading face-to-face interactions and other formal interactions with FDA and other health authorities; experience with Neurology Division of FDA preferred

•Regulatory leadership and team management experience

•Experience with CTD format and content for regulatory filings (e.g., INDs, CTAs, NDAs/BLAs, MAAs)

•Demonstrated track record in successfully progressing programs including INDs, early and late-stage development plans to completion, and in securing product approvals with successful NDAs/BLAs and/or MAAs

•Experience with expedited programs such as FastTrack, Breakthrough Therapy Designation, PRIME, Orphan Drug Designation

•Experience managing complex schedules and priorities in a dynamic environment; ability to adapt to shifting priorities, demands, and timelines through excellent analytical and problem-solving capabilities

•Creative, analytical problem solver who acts decisively yet communicates the risks and benefits associated with all potential solutions so that informed business decisions can be made

•Effectively represents function in negotiations with ability to resolve conflict in constructive manner

•Strong scientific acumen and eagerness to learn

•Ability to communicate effectively, orally and in writing, both internally and with external vendors and partners

•Results-oriented with strong initiative and accountability

•Familiarity with e-publishing systems for preparing regulatory submissions

•Familiarity with GCP, GMP and GLP


COMPENSATION & BENEFITS:

•Compensation is based on experience

•Yearly bonus plan

•Stock option award upon hire and annually

•401k match

•Medical, dental, long-term disability, short-term disability, life insurance/AD&D

•PTO

•Christmas holiday shutdown (fully paid)


DiaMedica Therapeutics Inc. believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.