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Director, Regulatory Affairs

2 weeks ago


Montreal Quebec GF, CA Ventus Therapeutics Full time

Director, Regulatory Affairs


About us:

Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology.

Our proprietary drug discovery platform, ReSOLVETM, gives us the ability to discover and develop medicines through unique insights into protein targets and to create dynamic blueprints that can guide the development of differentiated therapies at a fast pace. We aim to use the ReSOLVE platform to improve the way medicines are discovered and developed, with the ultimate goal of restoring the health of people facing serious illnesses.


Position Overview:

The Director of Regulatory Affairs will report to the SVP of Regulatory and Quality. The individual in this role is responsible for developing and implementing regulatory strategies, interfacing with regulatory agencies, identifying and managing regulatory risks, implementing the regulatory aspects of clinical trials, and developing and submitting regulatory documents, and therefore can have a significant impact on the company’s trajectory.


Key Duties and Responsibilities:

  • Executes preparation of regulatory documentation including authoring and/or reviewing and maintenance of initial applications, routine amendments, responses to information requests, meeting background materials/scientific advice to support interactions with
  • (Health Authorities) HAs, annual reports, IND safety reports/DSURs, and correspondence with HAs.
  • Leads cross-functional team discussions and works to gather consensus (e.g., leads meetings of regulatory submission documents such as HA briefing documents/scientific advice and meeting requests).
  • Leads, implements, and executes regulatory strategy (Clinical, Non-clinical, CMC) and global submission plans for early and/or late-stage projects.
  • As a strategic member of project teams across indications and programs, designs and develops regulatory (clinical, non-clinical and CMC) strategic options
  • Proactively defines and identifies regulatory risk and mitigation plans in support of product development plans.
  • Under the guidance of the SVP of Regulatory and Quality
  • Be the point of contact with regulatory agencies
  • Plan and lead meetings with regulatory authorities
  • Author and oversee the preparation of responses to all regulatory authority queries
  • Maintains strong relationships with cross-functional internal colleagues, and regulatory agencies, external CROs, regulatory consulting groups, and other third parties.
  • Participates in cross-functional teams, providing regulatory feedback and support.
  • Maintains up-to-date working knowledge of current FDA, EMA, MHRA and Ex-US regulations and guidelines as well as familiar with global regulatory environment. Proactively assesses and communicates impact, potential risks, and potential mitigations.
  • In conjunction with Regulatory Operations, develops processes and utilizes tools for creating, maintaining, tracking, and communicating regulatory submission and publishing plans, and timelines to internal stakeholders and external vendors.
  • Leads and/or participates in regulatory, technical and clinical operation initiatives to establish and improve processes and ways of working, keeping current with approaches to regulatory strategy, dossier strategy, and submissions.


Requirements:

  • A minimum of a BS/BA is required; advanced degree (MS or Pharm.D.) in scientific, regulatory, or related pharmaceutical field preferred.
  • 8 to 10 years of experience in the pharmaceutical, biotechnology or related industry.
  • Experience with global clinical trial applications, eCTD submissions and electronic document management systems, highly desirable.
  • Experience in multiple disciplines related to drug development strongly preferred.
  • Strong experience with regulatory CMC aspects of small molecule drugs.
  • Proven ability to prepare and submit documents to FDA and globally, such as, INDs, CTA or IMPDs.
  • Strong writing, project management and communication skills.
  • Demonstrated experience leading teams in producing complex, global regulatory submissions.
  • Proven skills in MS Word, PowerPoint, Project and a solid understanding of the eCTD and production of electronic submissions.
  • Ability to plan, set goals, determine objectives, enlist, and lead others to drive large, complex, critical regulatory submissions to completion to achieve department or company goals.
  • Demonstrated leadership in managing, authoring, or presenting on regulatory issues to departments or larger audiences.
  • This position can be remote, although proximity to one of our sites (Waltham, MA or Montreal, Quebec) is preferred.


_____________________________________________________________


Directeur des affaires réglementaires


Aperçu du poste :

Le directeur des affaires réglementaires est placé sous l'autorité du vice-président chargé des affaires réglementaires et de la qualité. Le titulaire de ce poste est responsable de l'élaboration et de la mise en œuvre de stratégies réglementaires, de l'interface avec les agences réglementaires, de l'identification et de la gestion des risques réglementaires, de la mise en œuvre des aspects réglementaires des essais cliniques, ainsi que de l'élaboration et de la soumission des documents réglementaires, et peut donc avoir un impact significatif sur la trajectoire de l'entreprise.


Principales tâches et responsabilités :

  • Préparer la documentation réglementaire, y compris la rédaction et/ou l'examen et la mise à jour des demandes initiales, des modifications de routine, des réponses aux demandes d'information, des documents de référence pour les réunions et des avis scientifiques afin de soutenir les interactions avec
  • (autorités sanitaires), rapports annuels, rapports de sécurité IND/DSUR et correspondance avec les autorités sanitaires.
  • Diriger des discussions au sein d'équipes interfonctionnelles et s'efforcer d'obtenir un consensus (par exemple, diriger des réunions portant sur des documents de soumission réglementaire tels que des documents d'information sur l'AP, des avis scientifiques et des demandes de réunion).
  • Diriger, mettre en œuvre et exécuter la stratégie réglementaire (clinique, non clinique, CMC) et les plans de soumission mondiaux pour les projets en phase initiale ou avancée.
  • En tant que membre stratégique des équipes de projet pour l'ensemble des indications et des programmes, concevoir et élaborer des options stratégiques en matière de réglementation (clinique, non clinique et CMC)
  • Définir et identifier de manière proactive les risques réglementaires et les plans d'atténuation à l'appui des plans de développement des produits.
  • Sous la direction du vice-président chargé de la réglementation et de la qualité
  • Être le point de contact avec les agences de régulation
  • Planifier et diriger les réunions avec les autorités réglementaires
  • Rédiger et superviser la préparation des réponses à toutes les demandes des autorités réglementaires.
  • Entretenir des relations étroites avec des collègues internes interfonctionnels, des agences de réglementation, des ORC externes, des groupes de conseil en réglementation et d'autres tiers.
  • Participer à des équipes interfonctionnelles, fournir un retour d'information et un soutien en matière de réglementation.
  • Maintenir une connaissance pratique et actualisée des réglementations et lignes directrices actuelles de la FDA, de l'EMA, de la MHRA et des États-Unis, ainsi qu'une bonne connaissance de l'environnement réglementaire mondial. Évaluer et communiquer de manière proactive l'impact, les risques potentiels et les mesures d'atténuation possibles.
  • En collaboration avec le service des opérations réglementaires, il élabore des processus et utilise des outils pour créer, maintenir, suivre et communiquer aux parties prenantes internes et aux fournisseurs externes les plans de soumission réglementaire et de publication, ainsi que les calendriers.
  • Diriger et/ou participer à des initiatives réglementaires, techniques et cliniques afin d'établir et d'améliorer les processus et les méthodes de travail, en se tenant au courant des approches en matière de stratégie réglementaire, de stratégie de dossier et de soumissions.


Exigences :

  • Un minimum de BS/BA est requis ; un diplôme d'études supérieures (MS ou Pharm.D.) dans le domaine scientifique, réglementaire ou pharmaceutique est préférable.
  • 8 à 10 ans d'expérience dans l'industrie pharmaceutique, biotechnologique ou connexe.
  • Une expérience des applications d'essais cliniques mondiaux, des soumissions eCTD et des systèmes de gestion des documents électroniques est vivement souhaitée.
  • Une expérience dans plusieurs disciplines liées au développement de médicaments est fortement souhaitée.
  • Forte expérience des aspects réglementaires CMC des médicaments à petites molécules.
  • Capacité avérée à préparer et à soumettre des documents à la FDA et au niveau mondial, tels que des IND, des CTA ou des IMPD.
  • Solides compétences en matière de rédaction, de gestion de projet et de communication.
  • Expérience avérée de la direction d'équipes chargées de produire des dossiers réglementaires complexes à l'échelle mondiale.
  • Compétences avérées en MS Word, PowerPoint, Project et une solide compréhension de l'eCTD et de la production de soumissions électroniques.
  • Capacité à planifier, à fixer des objectifs, à déterminer des objectifs, à mobiliser et à diriger d'autres personnes pour mener à bien des soumissions réglementaires importantes, complexes et critiques, afin d'atteindre les objectifs du département ou de l'entreprise.
  • Avoir fait preuve de leadership dans la gestion, la rédaction ou la présentation de questions réglementaires à des départements ou à des publics plus larges.
  • Ce poste peut être occupé à distance, mais la proximité de l'un de nos sites (Waltham, MA ou Montréal, Québec) est préférable.