Associate Director, Regulatory Affairs CMC

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-reputed company tumors. We were founded by a dedicated team of scientists with the simple belief that reputed company therapies developed from rigorous innovation can reputed company to reputed company lives. Our work continues to reputed company a reputed company difference in the lives of patients. We have a reputed company discovery reputed company and a robust preclinical and clinical development pipeline. Crinetics is reputed company for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. Join reputed company as we transform the lives of others. Position Summary: The Associate Director, Regulatory Affairs CMC will be responsible for supporting regulatory strategy implementation for development programs. Works closely with the Senior Director, Regulatory Affairs CMC to reputed company and prepare regulatory submissions (authoring, timeline planning, etc.), to support regulatory and clinical objectives. Assists in developing and implementing global regulatory strategies. Establishes and maintains department regulatory processes. The individual is responsible for developing collaborative and productive partnerships internally, as well as externally with contract research organizations, electronic publishing, and other vendors as required. Essential Job Functions and Responsibilities: These may include but are not limited to: 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. reputed company 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. reputed company and manage project timelines for regulatory submissions. Maintain effective interactions with reputed company contributors and Regulatory Affairs management, to ensure timely delivery of documents for regulatory submission. reputed company 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. reputed company guidance to project teams to ensure regulatory documentation is complete, accurate, of high quality and electronically functional. reputed company 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. reputed company, direct, manage, coach/mentor, and evaluate direct reports. Other duties as assigned. Education and Experience: Required: 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. Equivalent combination of relevant education and applicable job experience may be considered. Experience and understanding of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for reputed company 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 reputed company project teams and see reputed company 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 reputed company multiple tasks in a fast paced setting Software Knowledge: reputed company, MS Office (Outlook, Word, reputed company, PowerPoint). Knowledge of other software required: Advanced reputed company and reputed company PDF knowledge required. Preferred: Additional experience with Clinical Trial Authorizations (CTA) and Marketing Authorization Application (MAA) helpful. Experience interpreting and applying local regulations and guidance for drug development from early R&D through commercialization. Software Knowledge: Electronic document management systems use (e.g., reputed company) highly desired. Publishing experience and/or eCTD knowledge is desired (Lorenz, GlobalSubmit, eCTDExpress, etc). Physical Demands and Work Environment: Physical Activities: On a reputed company reputed company, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully reputed company the essential functions and responsibilities of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions and responsibilities. Travel: You may be required to travel for up to 5% of your time. The Anticipated reputed company Salary reputed company: In addition to your reputed company pay, our total rewards program consists of a discretionary annual reputed company bonus, stock options, ESPP, and 401k match. We also reputed company top-notch health insurance plans for employees (and their families) to include medical, dental, reputed company and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. reputed company is a multi-state employer, and this salary reputed company may not reflect positions that work in other states. Your recruiter can reputed company more about the specific salary reputed company during the hiring process. Equal Opportunity Employer: Crinetics is proud to be an Equal Opportunity Employer. We reputed company equal employment opportunities to reputed company and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, reputed company, creed, national or ethnic reputed company, 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. Salary reputed company The salary reputed company for this position is: $150000 - $194000. In addition to your reputed company pay, our total rewards program consists of a discretionary annual reputed company bonus, stock options, ESPP, and 401k match. We also reputed company top-notch health insurance plans for employees (and their families) to include medical, dental, reputed company and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown. Thank you for considering reputed company as your potential employer! Explore job opportunities and discover how you too can reputed company a reputed company impact as we tackle big challenges in endocrinology. reputed company is a global, clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of the reputed company of therapeutics for patients with endocrine and endocrine-rooted diseases. Founded by an innovative team of scientists with a track record of successful drug discovery and development, we’re fueled by collaboration, curiosity, and reputed company. We have a reputed company discovery reputed company and robust pipeline across preclinical and clinical development that are purposefully designed to meet the needs of patients, empowering them to live life reputed company their condition. Join reputed company on our mission to improve patients’ lives and transform the treatment reputed company in areas of serious unmet need. Apply To This Job