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South San Francisco, California, United States
Hybrid
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.
The Director Regulatory Affairs, Advertising and Promotion plays a critical role in providing strategic regulatory leadership and oversight for commercial, promotional, and medical communications. This role ensures that marketing campaigns, disease awareness initiatives, and corporate communications comply with FDA regulations, and company policies. Operating with a high degree of autonomy, the Director collaborates with clinical, medical, and legal to serve as a bridge between commercial tactics and regulatory compliance.
Key Responsibilities
US Regulatory Review & Compliance
Lead regulatory review and approval of U.S. product promotional materials.
Ensure product claims are supported by FDA-approved labeling and are scientifically substantiated
Serve as the regulatory advertising and promotion subject matter expert for the organization
Influence cross-functional decision making through strategic regulatory guidance.
Mentor junior regulatory professionals and contribute to talent development initiatives
Lead continuous improvement efforts related to promotional review processes and governance
Represent regulatory on the MLR Committee, and provide strategic regulatory input during new concept reviews, and review and approve materials for regulatory compliance
Review non-promotional assets, including medical, corporate affairs, market access/payor communications, and patient advocacy materials
Develop and update Important Safety Information (ISI) and risk presentations for use in commercial assets for target audiences
FDA Liaison & Submissions
Lead regulatory strategy for OPDP interactions, including advisory comments, enforcement responses, and regulatory correspondence as appropriate
Manage FDA Form 2253 submissions for applicable commercial assets
Lead voluntary advisory comment submissions for identified materials
Corporate Readiness & Training
Monitor OPDP enforcement trends and FDA guidance documents, and communicate relevant updates and learnings with cross functional stakeholders
Create or update standard operating procedures (SOPs) or work instructions to optimize and streamline work processes
Train U.S. marketing, sales, and medical affairs teams on regulatory compliance
Qualifications
Education
Required: Bachelor’s degree, Preferred: PharmD, PhD, or JD
Experience
Minimum 10 years in pharmaceutical or biotechnology regulatory affairs
At least 7 years focused on US advertising and promotion
Proven track record of successful launches for drug or biologic products
Direct history of managing interactions and submissions with OPDP
Skills & Competencies
Expert knowledge of FDA regulations governing biologics and promotional compliance
Proficiency with electronic review systems, specifically Veeva Vault PromoMats.
Ability to interpret complex clinical data into compliant marketing messages
Excellent written and verbal communication skills with executive-level stakeholders
Strong cross-functional collaboration skills to align marketing, medical, and legal stakeholders
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Pay Range:
The expected salary range for this position based on the primary location of South San Francisco, CA is $225,000-$262,500. The base pay offered will take into account internal equity and may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Base salary is just one component of our competitive total compensation package, which includes equity in the form of stock options and/or restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off. Note that benefits are subject to change and may vary based on jurisdiction of employment.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.
Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers
Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.
Here are some ways to check for authenticity:
We do not conduct job interviews through non-standard text messaging applications
We will never request personal information such as banking details until after an official offer has been accepted and verified
We will never request that you purchase equipment or other items when interviewing or hiring
If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer