Associate Director, Regulatory Affairs
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing next-in-class muscle activators and best-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. We take a purpose-driven approach by leveraging our unique muscle biology expertise to engineer compounds with specific characteristics aimed at treating diseases that impact muscle function, like heart failure, hypertrophic cardiomyopathy, ALS and SMA.
We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving lives. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop potential medicines to improve the healthspan of people with cardiovascular and neuromuscular diseases of impaired muscle function.
Reporting to the Director, Regulatory Affairs, the Associate Director of 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.
- Formulates regulatory strategies, with supervisor oversight, based on current regulatory intelligence
- Collaborates with cross-functional project teams and external business partners to develop regulatory strategies and identify regulatory risks
- Manages coordination, preparation, and timely submission of regulatory documents and filings
- Reviews global regulatory submissions for consistency and quality across regions
- Coordinates preparation of responses to queries from regulatory authorities
- Maintains up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs
- Ensures conformance to commitments made with various regulatory agencies (eg, IND/CTA commitments) for assigned programs
- Provides regulatory advice to other functional areas
- Participates in regulatory due diligence activities
- Builds and maintains collaborative relationships with external business partners to achieve project regulatory goals
- Develops and maintains collaborative relationships with other departments to ensure effective communication regarding project regulatory goals, issues and timelines
- Develops and maintains relationships with external vendors and regulatory health authorities
- Coordinates activities for meetings and conferences with FDA, EMA, and other regulatory authorities
- May supervise employees, consultants/contractors and interns in Regulatory Affairs
- Develops and implements regulatory operating guidelines and common work practices/strategies within the team
- 8+ years of drug development, including 5+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry; experience in small molecule drug development required
- Excellent working knowledge of international regulatory requirements and environment, 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
- Solid working knowledge of core processes: discovery, development, and manufacturing of small molecules
- Bachelor’s degree is required, preferably in a scientific discipline; advanced degree is a plus
- Experience with eCTD requirements and electronic submissions
- Experience with international regulatory submissions and processes is a strong plus
- Ability to work effectively across teams, functions and with outside partners
- Excellent oral and written communication skills
- Excellent organizational skills and attention to detail
Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer