At DiaMedica Therapeutics, we seek talented contributors who thrive in a high-energy team environment and want to make a real and lasting impact in the field of therapeutics. DiaMedica Therapeutics teams are creative, collaborative, open, committed–and central to the success of this company and its mission. If this is the kind of company you want to work for, we want to hear from you.
Please, no unsolicited resumes from recruiters.
The Director, Regulatory Affairs is responsible for overall management of the Regulatory Affairs function supporting DiaMedica Therapeutics’ drug development programs. This position directs, manages, and oversees regulatory activities in support of corporate objectives and develops and executes strategies for timely approval of high-quality development programs and marketed products.
- Ensure timely preparation, submission, liaison, and tracking of rigorous and compelling regulatory submissions, including Investigational New Drug Applications (IND) and New Drug Applications (NDA) and related correspondence.
- Act as the primary company contact for regulatory agencies.
- Prepare for and participate in meetings with regulatory agencies such as Food and Drug Administration (FDA) Pre-IND and Pre-NDA meetings.
- Maintain all regulatory files, ensuring documentation is complete, up to date, and audit ready.
- Prepare for and participate in internal and regulatory agency audits.
- Work closely with cross-functional teams, including CMC, pre-clinical, clinical, and quality, to ensure coordination of timelines and deliverables and confirm study designs meet regulatory requirements.
- Monitor and communicate changes in the regulatory landscape, provide expertise on requirements for current programs and products, and participate in the development of regulatory strategies to achieve company objectives.
- Identify issues that may increase regulatory and corporate risk and propose informed strategies to address such risks.
- Evaluate need for external expertise for submissions and manage and coordinate external input.
- May develop and provide work direction to regulatory department personnel through direct line management.
- Participate in organizational initiatives related to SOP development, training, or other projects.
- Bachelor degree
- 8+ years leadership experience in pharmaceutical or biopharmaceutical Regulatory Affairs
- Demonstrated working knowledge of the drug development process and US regulatory guidelines and regulations specific to INDs and NDAs
- Experience interfacing directly with regulatory authorities
- Strong leadership, organizational, negotiation, and problem-solving skills
- Excellent written and verbal communication skills and analytical skills, with high attention to detail and quality
- Experience in working with clinical development of protein biologics
- Experience with therapeutics that treat neurological and/or kidney diseases
- Track record of positive FDA interaction
- Experience with regulatory processes in the EU, Asia, or Australia
- Post-graduate degree in Regulatory Affairs and/or Regulatory Affairs Certification (RAC)
- Experience in electronic submission template (eCTD format)
LOCATION: Plymouth, Minnesota
ABOUT DIAMEDICA THERAPEUTICS:
DiaMedica Therapeutics is a biopharmaceutical company focused on the discovery and development of novel therapeutic compounds that target deficits in microvascular circulation such as ischemic stroke and diabetic nephrology. DiaMedica's lead compound, DM199, is a clinical stage recombinant human protein that represents a novel biological approach to improving brain and kidney function and moving into phase II studies.
We are an equal opportunity employer. It is our policy to provide equal employment opportunities to all qualified persons without regard to race, color, creed, sex, religion, national origin, age, marital status, disability, sexual orientation, protected veteran status, or status with regard to public assistance, local human rights commission activity, genetic information, or any other protected category and to comply with applicable federal, state, and local regulations regarding discrimination in employment.
Send cover letter and resume to HR@diamedica.com.