Associate Director, Regulatory Affairs CMC
Crinetics Pharmaceuticals
full-time
Posted on:
Location Type: Remote
Location: California • United States
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Salary
💰 $150,000 - $194,000 per year
Job Level
About the role
- 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
Requirements
- 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
Benefits
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionsINDsCTAsDSURsNDAregulatory strategyclinical study documentationregulatory intelligencestandard operating proceduresproject timelines
Soft Skills
leadershiporganizational skillscommunication skillsinterpersonal skillsability to prioritizeability to meet deadlinesability to work independentlycoachingmentoringteam collaboration