Associate Director, Regulatory Affairs

Cytokineticsis 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.

Responsibilities

Regulatory 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

• Bachelors 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 Range:

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 ourGeneral Data Protection Regulation (GDPR) policyPRIOR 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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Cytokinetics is an Equal Opportunity Employer