Senior Manager, Regulatory Affairs

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-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.

Reporting to the Associate Director, Regulatory Affairs, the Senior Manager of Regulatory Affairs leads regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international development strategies.

Responsibilities

• Formulate regulatory strategies, with supervisor oversight, based on current regulatory intelligence
• Collaborate with cross-functional project teams and external business partners to develop regulatory strategies and identify regulatory risks
• Manage coordination, preparation, and timely submission of regulatory documents and filings
• Review global regulatory submissions for consistency and quality across regions
• Manage preparation of responses to queries from regulatory authorities
• Maintain 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
• Ensure conformance to commitments made with various regulatory agencies (eg, IND/CTA commitments) for assigned programs
• Provide regulatory advice to other functional areas
• Participate in regulatory due diligence activities

Relationships

• Build and maintain collaborative relationships with external business partners to achieve project regulatory goals
• Develop and maintain collaborative relationships with other departments to ensure effective communication regarding project regulatory goals, issues and timelines
• Develop and manage relationships with external vendors and regulatory health authorities
• Manage activities for meetings and conferences with FDA, EMA, and other regulatory authorities

Management

• May supervise employees, consultants/contractors and interns in Regulatory Affairs
• Develop and implement regulatory operating guidelines and common work practices/strategies within the team

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.

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 strongly preferred; experience in small molecule drug development required; experience in the cardiovascular therapeutic area is a plus
• 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
• 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

Salary pay range: $165000 - $175000. Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled.  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.

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer