Associate Director, Regulatory Affairs
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.
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
Regulator _y Strategy and Program Support
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- 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
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- 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
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- 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
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.
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 applications
- We will never request personal information such as banking details until after an official offer has been accepted and verified
- We will never request that you purchase equipment or other items when interviewing or hiring
- If 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
