Regulatory Affairs Associate @ Cytokinetics

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 Regulatory Affairs Associate is responsible for coordination and preparation of a variety of regulatory submissions and for assisting the Regulatory Affairs team with various projects.

Responsibilities

Prepare and/or coordinate and comply routine regulatory submissions and other correspondence in accordance with regulatory agency regulations and guidelines
Review regulatory documents to ensure that all submissions are complete, accurate and meet relevant requirements
Interface with functional areas (CMC, Nonclinical, Clinical) to obtain information required for regulatory submissions
Assist with creating and maintaining regulatory timelines and tracking deliverables to ensure regulatory submission timelines are met
Assist with preparation for global regulatory team and subteam meetings
Develop and maintain tracking logs for regulatory activities
Monitor regulatory environment for changes to requirements
Support regulatory team through research on evolving regulatory issues, overall product landscape, etc, including searches of the relevant literature
Maintain current knowledge and expertise of FDA/EMA regulations and ICH guidelines
Collaborate with other functional areas in preparing and maintaining SOPs and appropriate regulatory operating guidelines
Assist with regulatory due diligence and inspection readiness activities

Qualifications

Bachelor’s degree in biology, chemistry, or related discipline with 2+ years’ experience in regulatory affairs or drug development preferred
RAC certification a plus
Ability to work effectively across teams, functions and with outside partners
Ability to prioritize and handle multiple competing tasks
Excellent oral and written communication skills
Excellent attention to detail with solid coordinating, task planning and time management skills

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

$104,000—$127,000 USD

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.

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

Compensation Overview

6 month growth

1 year growth

2 year growth