Job Description

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

Responsibilities:

• 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 U.S. and international requirements.
• Key focus on clinical regulatory strategy and regulatory path opportunities, and directly oversee 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 on 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:

• A Bachelor of Science degree, preferably in a life science field. Masters of Science or other advanced degree preferred.
• 10+ years of regulatory strategy and operations, managing programs across multiple phases in the pharmaceutical industry, ideally including 5+ years recently on neurology drug development programs.

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

• 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 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 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.

About DiaMedica Therapeutics Inc.

DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering from serious diseases with a current focus on acute ischemic stroke. DiaMedica’s lead candidate DM199 is the first pharmaceutically active and clinically studied recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality in China for the treatment of acute ischemic stroke and other vascular diseases. For more information visit the Company’s website at www.diamedica.com.