Regulatory Affairs Manager

Job not on LinkedIn

November 25

🏄 California – Remote

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

💵 $126k - $158k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

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Crinetics Pharmaceuticals

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Biotechnology • Pharmaceuticals • Healthcare Insurance

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.

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Actively participate as a member of Regulatory Affairs teams and on cross-functional product development teams as needed • Act as a regulatory lead on a Phase 1, 2 or 3 clinical study • Contribute to developing and implementing regulatory strategies for global submissions from early research and development (R&D) through commercialization • Support 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, routine submissions, 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 submissions • 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 • Write and/or maintain standard operating procedures, department working practices, templates and style guides, as appropriate • Conduct regulatory intelligence or research projects as required

🎯 Requirements

• Bachelor’s or M.S./Ph.D. degree in scientific area • Minimum of 7 years’ experience with a Bachelor’s or 5 years’ experience with M.S./Ph.D. of relevant Regulatory Affairs experience in a biotech/pharmaceutical setting • Minimum of 2 years supervisory experience • Experience and understanding of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP) requirements, 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 • Knowledge of Windows, MS Office (Outlook, Word, Excel, PowerPoint) • Advanced MS Word and Adobe PDF knowledge 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 • Electronic document management systems use (e.g., Veeva) highly desired • Publishing experience and/or eCTD knowledge is desired (Lorenz, GlobalSubmit, eCTDExpress, etc)

🏖️ 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