Cytokinetics

Director, Regulatory Affairs

South San Francisco, California · Director

Sponsorship not specified$225k-$263kDetected 31 days ago

ComplianceClinical TrialsFDA RegulatoryLeadershipCommunicationTime ManagementGxPRegulatory Affairs

About the role

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.
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.

Formulates regulatory strategies, with supervisor oversight, to support program objectives and oversees implementation of regulatory strategy and activities needed to secure approval of new drugs
Serves as a regulatory affairs lead on assigned clinical studies to support the development and execution of global regulatory strategies and provide regulatory advice to other functions
Builds and maintains collaborative relationships with cross-functional project teams, other departments, vendors, and external business partners to achieve program regulatory goals
Manages coordination, preparation, and timely submission of regulatory documents, filings, and responses to queries
Maintains current knowledge of laws, regulations and guidelines (eg, FDA, EMA, ICH, CDE, PMDA), as needed to support global programs
Mentors department personnel and optimizes employee performance by developing employees and promoting career growth
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 Senior Director, Regulatory Affairs, the Director, Regulatory Affairs is responsible for leading regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international development strategies.

Excellent working knowledge of international regulatory requirements and environment applicable to the clinical development and post-marketing space, including an understanding of GXP
Experience with eCTD requirements and electronic submissions
Demonstrated management expertise, including leadership and development of employees
Ability to work effectively in a fast-paced environment while managing multiple priorities
10+ years of drug development, including at least 7+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry; experience in small molecule drug development is preferred; experience in the cardiovascular therapeutic area is a plus
Bachelor's degree is required, preferably in a scientific discipline; advanced degree (MD, PharmD, or PhD) is a plus
Demonstrated knowledge of the regulatory requirements in the design and conduct of clinical trials, including the preparation of regulatory submissions
Ability to work effectively across teams, functions and with external partners
Excellent oral and written communication skills
Excellent organizational and time management skills, attention to detail, and ability to independently drive deliverables to completion

experience in small molecule drug development is preferred
10+ years of drug development, including at least 7+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry
experience in the cardiovascular therapeutic area is a plus
Bachelor's degree is required, preferably in a scientific discipline
advanced degree (MD, PharmD, or PhD) is a plus
Experience with international regulatory submissions and processes (eg, Canada, greater China, Japan) is a strong plus

In the U.S., the hiring pay range for fully qualified candidates is $225,000 - $262,500 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.
Ensures conformance to commitments made with various regulatory agencies (eg, IND/CTA commitments, annual obligations) for assigned programs

This listing is sourced directly from Cytokinetics's careers page and normalized into a canonical job model.