Associate Director, Regulatory Affairs CMC

Position Summary The Associate Director, Regulatory Affairs CMC will support regulatory strategy implementation for development programs. Working closely with the Senior Director, they will lead and prepare regulatory submissions, support regulatory and clinical objectives, and assist in developing and implementing global regulatory strategies. The role establishes and maintains departmental regulatory processes and builds collaborative partnerships internally and with external partners such as CROs and vendors. Essential Job Functions and Responsibilities 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 R&D through commercialization. Lead the compilation, review and 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 protocols, informed consent documents, 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, 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. Other duties as assigned. Education and Experience 10 years with a Bachelor’s or 8 years with an M.S./Ph.D. in relevant Regulatory Affairs experience in a biotech/pharmaceutical setting. Minimum of 7 years supervisory experience. Experience and understanding of ICH and FDA regulations. Experience with preparation of regulatory submissions, e.g., US IND and/or NDA sequences. Ability to work independently and within project teams, seeing projects through to completion. Excellent written and oral communication skills, strong organizational and interpersonal skills, and ability to meet deadlines in a fast‑paced setting. Software Knowledge Windows, MS Office (Outlook, Word, Excel, PowerPoint) – advanced Word and Adobe PDF knowledge required. Electronic document management systems (e.g., Veeva) highly desired. Publishing experience and/or eCTD knowledge desired (Lorenz, GlobalSubmit, eCTDExpress, etc.). Physical Demands and Work Environment On a continuous basis, sit at a desk for a long period of time; intermittently answer the telephone and use a keyboard. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. Travel Travel may be required for up to 5% of the time. Compensation The anticipated base salary range for this position is $150,000 - $194,000. In addition to base pay, the total rewards program includes a discretionary annual target bonus, stock options, ESPP, and 401k match. Health insurance (medical, dental, vision, basic life) and 20 days PTO, 10 paid holidays, and a winter company shutdown are also provided. Equal Opportunity Employer Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. #J-18808-Ljbffr