Associate Director, Regulatory Affairs CMC

🕒 Fevereiro 28

🏄 California – Remoto

🏄 California – Remote

💵 $150.000 - $194.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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Crinetics Pharmaceuticals

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2015

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

A Crinetics Pharmaceuticals é uma empresa de biotecnologia que desenvolve terapias inovadoras para doenças endócrinas. A empresa está focada em atender necessidades médicas não atendidas, criando tratamentos para condições como acromegalia, síndrome carcinoide, síndrome de Cushing dependente de ACTH, hiperplasia adrenal congênita e outros distúrbios endócrinos. A Crinetics está comprometida em melhorar a qualidade de vida dos pacientes através de ciência de ponta e ensaios clínicos robustos. Seu pipeline inclui candidatos promissores como paltusotina, que foi aceita pelo Food and Drug Administration dos EUA para o tratamento de pacientes adultos com acromegalia. A empresa colabora com profissionais de saúde e partes interessadas para garantir que suas terapias abordem problemas reais de forma eficaz e agreguem valor para os investidores ao entrar em nichos de mercado com necessidades significativas.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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