Crinetics Pharmaceuticals

Associate Director, Regulatory Affairs CMC

Remote, USA · Director

Sponsorship not specified$150k-$194kDetected 79 days ago

ExcelFDA RegulatoryResearchAnimal StudiesCommunicationOrganizational SkillsMicrosoft OfficeRegulatory Affairs

About the role

The Associate Director, Regulatory Affairs CMC will be responsible for supporting regulatory strategy implementation for development programs.
Essential Job Functions and Responsibilities:
These may include but are not limited to:

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.
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.
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.

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.
Strong organizational skills, including the ability to prioritize workload.
Strong interpersonal skills and the ability to deal effectively with other people/departments.
Advanced MS Word and Adobe PDF knowledge required.
Some walking and lifting up to 25 lbs. may be required.

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.

The salary range for this position is: $150000 - $194000.
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match.
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.
Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states.
Your recruiter can share more about the specific salary range during the hiring process.
The Anticipated Base Salary Range:
Coordinate and contribute to the authoring of submission documents such as DSURs, annual reports, and amendments as needed.

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors.
We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives.
Our work continues to make a real difference in the lives of patients.
We have a prolific discovery engine and a robust preclinical and clinical development pipeline.
Crinetics is known 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 our team as we transform the lives of others.

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.
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.

tation, 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 s

This listing is sourced directly from Crinetics Pharmaceuticals's careers page and normalized into a canonical job model.