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
Identifies gaps in product development plans that may pose regulatory risks and identifies related solutions and mitigation plans
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
Reviews global regulatory submissions for consistency and quality across regions
Maintains current knowledge of laws, regulations and guidelines (eg, FDA, EMA, ICH, CDE, PMDA), as needed to support global programs
Ensures conformance to commitments made with various regulatory agencies (eg, IND/CTA commitments, annual obligations) for assigned programs
Contributes to regulatory department initiatives, including the development and maintenance of internal regulatory processes, operating guidelines, templates, and best practices
Supervises employees, consultants/contractors, and/or interns in Regulatory Affairs
Mentors department personnel and optimizes employee performance by developing employees and promoting career growth
Requirements
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
Excellent working knowledge of international regulatory requirements and environment applicable to the clinical development and post-marketing space, including an understanding of GXP
Demonstrated knowledge of the regulatory requirements in the design and conduct of clinical trials, including the preparation of regulatory submissions
Experience with eCTD requirements and electronic submissions
Experience with international regulatory submissions and processes (eg, Canada, greater China, Japan) is a strong plus
Demonstrated management expertise, including leadership and development of employees
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
Ability to work effectively in a fast-paced environment while managing multiple priorities
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Pay Range:
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.
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Benefits
Equity / stock options
Additional 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.
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.
Cytokinetics · South San Francisco, CA