Associate Director, Regulatory Affairs CMC

🕒 vor 3 Monaten

🏄 California – Remote

🏄 California – Remote

💵 $150.000 - $194.000 / Jahr

⏰ Vollzeit

🟠 Senior

🚔 Compliance

Jetzt Bewerben

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Crinetics Pharmaceuticals

WebsiteLinkedInAlle Stellen

201 - 500 Mitarbeiter

Gegründet 2015

🧬 Biotechnologie

💊 Pharmazie

⚕️ Krankenversicherung

Biotechnology • Pharmaceuticals • Healthcare Insurance

Crinetics Pharmaceuticals ist ein Biotechnologieunternehmen, das innovative Therapien für endokrine Erkrankungen entwickelt. Das Unternehmen konzentriert sich darauf, ungedeckte medizinische Bedürfnisse zu adressieren, indem es Behandlungen für Zustände wie Akromegalie, Karzinoid-Syndrom, ACTH-abhängiges Cushing-Syndrom, kongenitale Nebennierenhyperplasie und andere endokrine Störungen schafft. Crinetics engagiert sich für die Verbesserung der Lebensqualität von Patienten durch modernste Wissenschaft und robuste klinische Studien. Ihre Pipeline umfasst vielversprechende Kandidaten wie Paltusotin, das von der US-amerikanischen Food and Drug Administration für die Behandlung von erwachsenen Patienten mit Akromegalie akzeptiert wurde. Das Unternehmen arbeitet mit Leistungserbringern im Gesundheitswesen und Stakeholdern zusammen, um sicherzustellen, dass ihre Therapien reale Probleme effektiv angehen und für Investoren Wert schaffen, indem sie Marktnischen mit signifikanten Bedürfnissen betreten.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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