Manager - Regulatory Submissions

April 3

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $110k - $137k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

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Crinetics Pharmaceuticals

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Crinetics Pharmaceuticals is a biotechnology company that develops innovative therapies for endocrine diseases. The company is focused on addressing unmet medical needs by creating treatments for conditions such as acromegaly, carcinoid syndrome, ACTH-dependent Cushing’s syndrome, congenital adrenal hyperplasia, and other endocrine disorders. Crinetics is committed to improving the quality of life for patients through cutting-edge science and robust clinical trials. Their pipeline includes promising candidates like paltusotine, which has been accepted by the U. S. Food and Drug Administration for the treatment of adult patients with acromegaly. The company collaborates with healthcare practitioners and stakeholders to ensure that their therapies address real-life problems effectively and build value for investors by entering market niches with significant needs.

Drug Discovery • Endocrinology • RareDisease • Biotech

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Manage high impact, complex submission projects involving multiple cross-functional regulatory submission teams. • Establish and maintain submission content planners and associated timelines. • Participate in submission team meetings. • Prepare content planners for publishing and fulfill submission management functions on project teams. • Ensure the successful preparation and filing of regulatory submissions at Crinetics. • Establish standards and perform submission tracking, document collection, quality control, publication, transmission, and archival. • Maintain electronic document management and publishing systems necessary to produce high-quality submissions. • Liaise with external regulatory operations vendors.

🎯 Requirements

• Bachelor’s degree • Minimum 8 years of relevant experience in the biotech or pharmaceutical industry • Minimum 2 years of experience working with submission content planning • Strong working knowledge of regulatory submission publishing standards and procedures • Preferred: Experience working with Veeva RIM document management system; StartingPoint templates; Smartsheet content planning eCTD U.S. and MAA

🏖️ Benefits

• Discretionary annual target bonus • Stock options • ESPP • 401k match • Top-notch health insurance plans for employees and their families (including medical, dental, vision, and basic life insurance) • 20 days of PTO • 10 paid holidays • Winter company shutdown