Associate Director, Regulatory Affairs CMC

🕒 il y a 3 mois

🏄 California – Distant

🏄 California – Remote

💵 $150 000 - $194 000 / an

⏰ Temps Plein

🟠 Senior

🚔 Conformité

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Crinetics Pharmaceuticals

Site WebLinkedInTous les Emplois

201 - 500 employés

Fondée en 2015

🧬 Biotechnologie

💊 Pharmaceutique

⚕️ Assurance santé

Biotechnology • Pharmaceuticals • Healthcare Insurance

Crinetics Pharmaceuticals est une entreprise de biotechnologie qui développe des thérapies innovantes pour les maladies endocriniennes. L'entreprise se concentre sur le traitement des besoins médicaux non satisfaits en créant des traitements pour des affections telles que l'acromégalie, le syndrome carcinoïde, le syndrome de Cushing ACTH-dépendant, l'hyperplasie surrénale congénitale, et d'autres troubles endocriniens. Crinetics s'engage à améliorer la qualité de vie des patients grâce à une science de pointe et des essais cliniques robustes. Leur portefeuille comprend des candidats prometteurs comme le paltusotine, qui a été accepté par la Food and Drug Administration des États-Unis pour le traitement des patients adultes atteints d'acromégalie. L'entreprise collabore avec des praticiens de santé et des parties prenantes pour s'assurer que leurs thérapies répondent efficacement aux problèmes réels et construisent de la valeur pour les investisseurs en entrant dans des niches de marché avec des besoins significatifs.

Description

• support regulatory strategy implementation for development programs • lead and prepare regulatory submissions (authoring, timeline planning, etc.) • assist in developing and implementing global regulatory strategies • establish and maintain department regulatory processes • develop collaborative and productive partnerships internally, as well as externally with contract research organizations, electronic publishing, and other vendors as required • actively participate as a member of Regulatory Affairs teams and on cross-functional product development teams as needed • contribute to developing and implementing regulatory strategies for global submissions from early research and development (R&D) through commercialization • lead the compilation, review and/or filing of INDs, CTAs, briefing documents and maintenance of development and approved applications • coordinate and contribute to the authoring of submission documents such as DSURs, annual reports, and amendments as needed • develop and manage project timelines for regulatory submissions • maintain effective interactions with all contributors and Regulatory Affairs management, to ensure timely delivery of documents for regulatory submission • provide regulatory assistance and review of clinical study documentation, including review of clinical protocols, informed consent documents, clinical study recruitment materials, and essential document packages • track submissions, correspondence, and commitments with health authorities • provide guidance to project teams to ensure regulatory documentation is complete, accurate, of high quality and electronically functional • provide regulatory intelligence and research to the team as needed • write and/or maintain standard operating procedures, department working practices, templates and style guides, as appropriate • lead, direct, manage, coach/mentor, and evaluate direct reports

🎯 Exigences

• 10 years with Bachelor’s or 8 years with M.S./Ph.D. of relevant Regulatory Affairs experience in a biotech/pharmaceutical setting • Minimum of 7 years supervisory experience • Experience and understanding of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and FDA regulations • Experience and knowledge in the preparation of regulatory submissions, i.e. US IND and/or NDA sequences • Ability to work both independently with direction and within project teams and see all projects through to their completion • Excellent written and oral communication skills • Strong organizational skills, including the ability to prioritize workload • Strong interpersonal skills and the ability to deal effectively with other people/departments • Ability to meet deadlines and perform multiple tasks in a fast paced setting • Software Knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint) • Knowledge of other software required: Advanced MS Word and Adobe PDF knowledge required

🏖️ Avantages

• discretionary annual target bonus • stock options • ESPP • 401k match • top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance • 20 days of PTO • 10 paid holidays • winter company shutdown