Job Description
## Associate Director, Regulatory AffairsApplyremote type: Hybridlocations: South San Francisco, Californiatime type: Full timeposted on: Posted 2 Days Agojob requisition id: R538Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.Reporting to the Executive Director, Regulatory Affairs, the Associate Director, Regulatory Affairs, is responsible for hands-on regulatory activities across development stages, ensuring high-quality submissions and effective interactions with health authorities. The position operates in a highly collaborative, fast-paced biotech environment with significant cross-functional engagement.**R****esponsibilities***Regulator**y Strategy and Program Support** Contribute to development and execution of regulatory strategies for assigned programs and serve as regulatory lead for assigned clinical studies* Identify potential regulatory risks and develop mitigation approaches* Provide regulatory guidance throughout product development to cross-functional teams such as study operating teams and assigned workstreams* Lead preparation, review, and timely submission of high-quality, compliant regulatory documents (INDs, CTAs, amendments; NDAs, supplements) and moderately complex regulatory submissions* Contribute to department initiatives, including the development and maintenance of internal regulatory processes, operating guidelines, templates, and best practices*Health Authority Engagement** Support preparation for health authority interactions, including briefing packages and response documents* Participate in agency communications and help track commitments and action items*Regulatory Intelligence and Compliance** Stay current with evolving global regulatory requirements, including therapeutic area-specific guidances and scientific developments, and assess potential impact on programs* Ensure regulatory activities are conducted in accordance with applicable regulations and company procedures**Qualifications*** Bachelor's degree is required, preferably in a scientific field; advanced degree is a plus* 8+ years of drug development, including 5+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry* Excellent working knowledge of global regulatory requirements (FDA, EMA, ICH), including an understanding of GXP* Experience supporting regulatory submissions (e.g., IND/CTA/eCTD) and health authority interactions* Proven ability to manage multiple priorities and work effectively across teams, functions and with external partners* Excellent written and verbal communication skills* Excellent organizational and product coordination skills#LI-HYBRID**Pay Range:**In the U.S., the hiring pay range for fully qualified candidates is $200,700-$234,150 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.*Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.***Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.**Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
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