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.
Cytokinetics is seeking an experienced, strategic and motivated Director, Regulatory Labeling, who is a strong team player and enjoys a fast paced, dynamic work environment. Reporting to the Head of Labeling, the Director of Regulatory Labeling is the Global Labeling Lead and will support the development of labeling for assigned development programs and/or marketed products. The Global Labeling Lead will provide input on labeling requirements and strategic guidance during label development, facilitating cross functional labeling discussions and participating in label-related Health Authority negotiations.
The Director will be responsible for supporting the end-to-end labeling process including lifecycle management of labeling and artwork.This position offers the opportunity to contribute to the development and success of the regulatory labeling organization that is part of an innovative biopharmaceutical company striving to bring important new medicines to patients.
Responsibilities
- The Global Labeling Lead is responsible for leading the development of Company Core Data Sheets (CCDS) and global labeling content (focus on US, EU and Canada), as applicable across regions through collaboration with key internal stakeholders
- Create and maintain regulatory compliant, competitive, and up to date CCDS for assigned key development projects and marketed products
- Review worldwide labeling against the CCDS and facilitate and track implementation of changes to align with core content
- Participate in label-related Health Authority negotiation meetings
- Contribute to maintenance and updates of labeling processes
- As a member of the Global Regulatory Team ensure timely implementation of global labeling changes in local product information that are consistent with the company's position defined in the CCDS and in compliance with local labeling regulations
- Review final artwork to be implemented into production, including approval of all change requests for revised labeling for assigned products
- Maintain knowledge of current rules and regulations governing global labeling activities
- Participate in interpretation and implementation of key regional labeling regulations, guidelines, and best labeling practices, and align with global strategic plan
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
- Science based BS or MS degree. Advanced degree (MD, Ph D, PharmD) preferred
- Seasoned regulatory professional with 10+ years of industry experience and extensive experience (at least 6 years) in global regulatory labeling
- Thorough understanding of regulatory labeling requirements and strategic labeling planning
- Direct experience leading labeling content development through regulatory submission and review process, participating in Health Authority negotiations resulting in product approval
- Experience maintaining the CCDS and global labeling throughout the product lifecycle
- Experience leading cross-functional teams and negotiating with internal and external stakeholders on labeling issues
- Strong writing skills; able to process scientific data and effectively summarize into the appropriate detail for labeling content
- Strong interpersonal and communication (written and verbal) skills
- Fluency in English as business language, additional languages advantageous
- Cardiovascular therapeutic area experience is desirable
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
