VP, Regulatory Affairs

DiaMedica is a clinical stage biopharmaceutical company bringing their lead candidate, DM199, through clinical development.

DM199 (rinvecalinase alfa) is a synthetic form of human tissue kallikrein-1 (rhKLK1) in clinical 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 treatment of preeclampsia, DM199 is intended to lower blood pressure, enhance endothelial health and improve perfusion to maternal organs and the placenta. In the treatment of AIS, 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.

Reporting to the Chief Development Officer, the VP, Regulatory Affairs will be responsible for the oversight and execution of global regulatory strategies across DiaMedica’s development programs. This individual will serve as the internal lead for all regulatory activities, ensuring alignment with evolving program needs and global regulatory expectations. The VP, Regulatory Affairs will work closely with external consultants and internal cross-functional teams to operationalize strategic plans and deliver high-quality regulatory submissions.

Major Responsibilities:

• Oversee and execute global regulatory strategies to support development, registration, and lifecycle management of DiaMedica’s pipeline.

• 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 consultant(s), as required, to ensure the compliance of DiaMedica’s development activities with all U.S. and international requirements.

• Serve as the internal lead for all regulatory submissions (e.g., INDs, NDAs, BLAs, MAAs, CTAs), including ownership of submission timelines, document quality, and cross-functional coordination.

• 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.

• Support identification and pursuit of accelerated regulatory pathways (e.g., Orphan Drug Designation, Fast Track, Breakthrough Therapy, PRIME).

• 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.

Required Qualifications:

• A Bachelor of Science degree, preferably in a life science field. Masters of Science or other advanced degree preferred.

• 10+ years of regulatory experience in the pharmaceutical/biotech industry including regulatory oversight across multiple development phases, ideally including 5+ years recently on neurology or women’s health drug development programs.

• Strong experience working with the FDA, utilizing novel regulatory pathways and applying creative approaches where appropriate

• Experience with biologics and protein therapeutics highly preferred. 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.

• Significant 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 Orphan Drug Designation, Fast Track, Breakthrough Therapy Designation, and PRIME.

• 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 the ability to resolve conflict in a 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.

Additional Information:

This position resides within a remote office working environment with very little travel required.

The base salary range for this position is $153,000 – 230,000; the exact salary depends on several factors such as experience, skills, education, and budget. In addition to base salary, this position is eligible for participation in a highly competitive bonus program with possibility for overachievement based on performance and company results. It is eligible to participate in our long-term incentive program.

DiaMedica offers a variety of benefits to eligible employees, including health insurance coverage, wellness and family support programs, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and vacation time, and many others. Many of these benefits are subsidized or fully paid for by the company.

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.