Join us as our Director of Regulatory Affairs

Thryv Therapeutics Inc. (previously LQT Therapeutics Inc.), is a privately owned company based in Montreal, Quebec, Canada. They have been pioneering a precision medicine approach to treat Long QT Syndrome via SGK1 inhibition since 2019 and have since evolved their portfolio to include the treatment of resistant and rare cancers.

OPPORTUNITY SUMMARY

The Director of Regulatory Affairs is responsible for leading and reviewing the company’s regulatory strategy and gaining an understanding of the regulatory requirements for approval, to make recommendations to the development team. He/she supervises the preparation of all regulatory agency submissions, compliance and communications. The Director Regulatory Affairs reports to the Vice President Drug Development.

 KEY RESPONSIBILITIES

  • Reviews clinical, non-clinical and CMC strategy and makes recommendations for regulatory success

  • Ensures that the regulatory pathway is met optimally, gaining an understanding of the regulatory requirements to approval to make recommendations to the development team

  • Contributes and supervises the regulatory dossier preparation providing recommendations for all sections, including personally preparing documents as required

  • Ensures timeliness of responses to Agencies questions and of submissions preparation

  • Prepares and executes the strategy for interactions and meetings with regulatory agencies.

  • Interacts with regulatory KOLs to streamline company’s regulatory strategy

  • Ensures corporate documents are in accordance with regulatory requirements and guidelines

  • Ensures continuing compliance with relevant Company, local law and regulatory authority requirements

EDUCATION & WORK EXPERIENCE

  • 5-10 years of pharmaceutical/biotech industry experience in regulatory affairs

  • Strong regulatory knowledge of non-clinical drug development and clinical trials requirements

  • Experience in phase 1/2 drug development program. Cardiology experience is a plus. Experience with rare diseases a plus

  • Small company experience utilizing a highly outsourced model is required

  • NDA (incl. approval) experience highly preferred. FDA Cardio-renal division experience is a plus

  • FDA and Health Canada experience required, other Health Authorities experience is a plus

  • Experience preparing and attending meetings with FDA

  • Worked successfully with non-clinical and Phase 1 and Phase 2 clinical trials. Phase 3 clinical trial experience a plus

  • Track record of moving drugs successfully through the various stages of the regulatory process

  • Ability to develop regulatory strategies and contingency plans

  • Successful NDA / IND / interactions with regulatory agencies (FDA, Health Canada, EMA, etc.)

  • Experience in due diligences

  • Ability to think out of the box and generate creative and realistic regulatory solutions in pharma and biotech environments

  • Enjoys working in a strong, highly productive, small company environment

  • Ability to travel as needed.  Relocation preferable but may not be necessary

  • Advanced degree preferred (M.S. or Ph.D.) in Life Sciences, or equivalent

  • RAPS certification (RAC) is a plus

TECHNICAL KNOWLEDGE & SKILLS

  • Extensive knowledge of US and Canadian regulations and good understanding of European regulations. Knowledge of other jurisdictions is a plus

  • Ability to develop and implement regulatory strategy tools

  • Operational knowledge of global GMP, GCP and GLP

  • Expert knowledge in pharmaceutical regulations

  • Operational knowledge of CMC requirements

  • Operational knowledge of pharmaceutical product development and clinical study processes

NON-TECHNICAL SKILLS & COMPETENCIES

  • Exudes the highest level of integrity and an acute sense of ethics

  • Operates with a sense of urgency and perseverance to achieve results

  • Superior problem solving, conflict management and interpersonal skills

  • High-energy, proactive, charismatic style as a hands-on driver

  • A natural partner and educator with the capability of taking decisions

  • Ability and enthusiasm to work in a cross-functional team environment

  • Superior organizational skills with the ability to multi-task and prioritize assignments

  • Excellent oral/written communication, interpersonal, organizational and presentation skills

  • Self-motivated with the ability to work independently with minimal supervision; and

  • Ability to work under pressure to meet deadlines or manage crisis situation 

TRAVEL

Willingness/Ability to travel up to 20% domestically and internationally.

EQUAL OPPORTUNITY WORKPLACE

Thryv Therapeutics Inc. is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, and any other characteristic protected by law, rule, or regulation.

APPLY

Please send your resume and cover letter to admin@thryvtrx.com