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 Associate Director, Regulatory Operations, the Regulatory Operations Manager is responsible for formatting and publishing electronic documents, ensuring submissions are of highest quality and delivered on time, and assisting with project oversight of complex submissions. This role is onsite hybrid in our South San Francisco office.
Responsibilities:
- Publish high-quality electronic regulatory submissions (eCTD and other formats as appropriate) for submittal to global health authorities including FDA, EMA, Swiss Medic, Health Canada, and others
- Publish submissions ranging in complexity from routine (e.g., IND investigator updates) to original applications and major updates to existing applications (e.g., original INDs/NDAs/MAAs, sNDAs, major IND amendments)
- Manage and triage workload for large/complex submissions
- Format MS word documents and reports, and ensure generation of final PDF documents that conform to health authority technical requirements. In addition, prepare CSR appendices and perform report-level publishing
- Perform quality control checks on formatted documents and published outputs prior to submission to health authorities
- Provide training on Cytokinetics CTD/document templates sand style guide
- Archive paper and electronic submissions
- Provide Regulatory Affairs and other Cytokinetics functions guidance during document development on aspects related to publishing and electronic submissions
- Identify and resolve document formatting and/or publishing issues, working with responsible parties as needed
- Monitor changes to ICH and health authority electronic submission guidance and work with Regulatory Operations team to update processes and standards
- Assist with development of new and updated department SOPs, Work Instructions
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 in life sciences, information technology, or business with 6+ years of experience in pharmaceutical Regulatory Operations or similar discipline
- Hand-on experience publishing, publishing original applications and maintenance submissions for INDs, NDAs, CTAs, MAAs (EU and other countries), and NDSs.
- Experience with project managing complex submissions.
- Proficient knowledge of and experience with electronic publishing tools for regulatory submissions (e.g., Lorenz docuBridge, Extedo eCTD Manager, IQVIA RIM Smart, etc.).
- Thorough understanding of applicable FDA, HC, EU and ICH guidelines related to regulatory submissions, clinical trials and marketing applications.
- Expert knowledge of eCTD submission requirements and lifecycle management concepts for eCTD submissions.
- Expert skills in using MS Office Suite, Adobe Acrobat and ISIToolBox, SharePoint, EndNote, Accenture StartingPoint templates, and other relevant tools.
- Experience with document formatting (Word and PDF).
- Demonstrated organizational skills, attention to detail and ability to quickly adjust to changes in priorities and work under pressure in a fast-paced environment to meet tight submission and project deadlines.
- Strong project management, communication and interpersonal skills; demonstrated ability to independently learn new technologies, processes and regulatory requirements.
- Ability to work independently, troubleshoot system and validation errors, and make knowledgeable decisions.
- Bachelor's degree in life sciences, information technology, or business.
Salary Pay Range: $147,000 - $163,000. 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.
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
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.
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
