Associate Director, Regulatory Affairs CMC

Crinetics Pharmaceuticals • Headquarters, KY

1d • $150,000 - $194,000

About The Position

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. 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 lead 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.

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.
• 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 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
• Windows, MS Office (Outlook, Word, Excel, PowerPoint).
• Advanced MS Word and Adobe PDF knowledge required.

Nice To Haves

• 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.
• Electronic document management systems use (e.g., Veeva) highly desired.
• Publishing experience and/or eCTD knowledge is desired (Lorenz, GlobalSubmit, eCTDExpress, etc).

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 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.
• Other duties as assigned.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level