Director, Regulatory Affairs

Responsibilities

• 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

Qualifications

• 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 GXPDemonstrated 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
• Excellent oral and written communication skills
• Excellent organizational and time management skills, attention to detail, and ability to independently drive deliverables to completion
• Able to work effectively in a fast-paced environment while managing multiple priorities

Pay

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.

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. 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.

Prior to applying, please review our General Data Protection Regulation (GDPR) policy. 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.