Cytokinetics is a late-stage, specialty cardiovascular 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 cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
Reporting to the Senior Director of Regulatory Affairs, the Associate Director, Regulatory Affairs is responsible for coordination and preparation of a variety of regulatory submissions and for assisting the Regulatory Affairs team with various projects.
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, identify regulatory risks and provide regulatory advice
- Serve as primary regulatory representative for clinical studies and/or as the regulatory program lead
- Manage coordination, preparation, and timely submission of regulatory documents and filings
- Review global regulatory submissions for consistency and quality across regions, ensuring conformance to commitments made with various regulatory agencies (eg, IND/CTA commitments)
- Coordinate 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
- Participate in regulatory due diligence activities
Relationships
- Build and maintain collaborative relationships with external business partners and vendors to achieve project regulatory goals
- Develop and maintain collaborative relationships with other departments to ensure effective communication regarding project regulatory goals, issues and timelines
- Coordinate 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 standard operating procedures
Qualifications
- Bachelor’s degree, preferably in a scientific discipline, with 8+ years of drug development and 5+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry
- 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
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.Salary Pay Range$162,000—$198,000 USDOur 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.
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
