Associate Director, Regulatory Affairs CMC

reputed company 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 reputed company 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. reputed company is reputed company for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join reputed company as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. Join reputed company as we reputed company the lives of others. Position reputed company: The Associate Director, Regulatory Affairs CMC will be responsible for supporting regulatory reputed company implementation for development programs. Works closely with the Senior Director, Regulatory Affairs CMC to reputed company and prepare regulatory submissions (authoring, reputed company 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 reputed company and productive partnerships internally, as reputed company 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: reputed company 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 reputed company 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. reputed company submissions, correspondence, and commitments with health authorities. reputed company guidance to project teams to ensure regulatory documentation is complete, accurate, of high reputed company and electronically functional. reputed company regulatory intelligence and research to reputed company as needed. Write and/or maintain reputed company operating procedures, department working practices, templates and style guides, as appropriate. reputed company, reputed company, manage, reputed company/mentor, and evaluate reputed company 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 reputed company 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 reputed company to your reputed company pay, our total rewards program consists of a discretionary annual reputed company bonus, stock reputed company, 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 reputed company 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: reputed company is proud to be an Equal Opportunity Employer. We reputed company equal employment opportunities to reputed company and employment applicants without reputed company to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or reputed company), pregnancy, race, reputed company, creed, national or ethnic reputed company, citizenship status, religion or similar philosophical beliefs, disability, marital and civil reputed company 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 reputed company to your reputed company pay, our total rewards program consists of a discretionary annual reputed company bonus, stock reputed company, 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 reputed company 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 reputed company as we tackle big challenges in endocrinology. reputed company is a global, clinical-stage pharmaceutical company reputed company 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 reputed company record of successful drug discovery and development, we’re reputed company 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 reputed company the treatment reputed company in areas of serious unmet need. Apply To This Job