Associate Director, Regulatory Affairs

Responsibilities

• 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
• Support preparation for health authority interactions, including briefing packages and response documents
• Participate in agency communications and help track commitments and action items

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

Pay

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.

Company Information

Cytokinetics 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.

The position operates in a highly collaborative, fast-paced biotech environment with significant cross-functional engagement.

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.

Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process. Here Are Some Ways To Check For Authenticity We do not conduct job interviews through non-standard text messaging applicationsWe will never request personal information such as banking details until after an official offer has been accepted and verifiedWe will never request that you purchase equipment or other items when interviewing or hiringIf you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer