Director, US Regulatory Affairs, Advertising & Promotion

Cytokinetics, Inc.; Radnor (Delaware County); Hybrid; USD 213,000 - 249,000; Full time

Benefits offered by this job

Equity in stock options and RSUs

Comprehensive health insurance

Dental insurance

Vision insurance

Life and disability insurance

401(k) with employer match

Learning and wellness stipends

Paid time off

Job summary

Cytokinetics, Inc. in Radnor, PA, is seeking a Director Regulatory Affairs, Advertising and Promotion to lead US promotional material reviews, ensure FDA labeling support, and shape regulatory strategy across marketing, medical, and legal teams.

This role requires at least 10 years in pharmaceutical/biotech regulatory affairs with 7 years in U.S. advertising and promotion, a strong track record of launches, and proficiency with PromoMats; hybrid work arrangement with competitive compensation and

Qualifications

• Bachelor’s degree required; PharmD/PhD/JD preferred.
• Minimum 10 years in pharmaceutical/biotech regulatory affairs.
• At least 7 years focused on U.S. advertising and promotion.
• Proven track record of successful launches for drug or biologic products.
• Direct history of managing OPDP interactions and submissions.

Responsibilities

• 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 SME for the organization.
• Influence cross-functional decision making through strategic regulatory guidance.
• Mentor junior regulatory professionals and contribute to talent development.
• Lead continuous improvement efforts related to promotional review processes and governance.
• Represent regulatory on the MLR Committee and approval of materials for compliance.
• Review non-promotional assets such as medical, corporate affairs, market access/payor, and patient advocacy materials.
• Develop and update Important Safety Information (ISI) and risk presentations for commercial assets.
• Lead regulatory strategy for OPDP interactions and regulatory correspondence.
• Manage FDA Form 2253 submissions for applicable commercial assets.
• Lead voluntary advisory comment submissions for identified materials.
• Monitor OPDP trends and FDA guidance; communicate updates cross-functionally.
• Create or update SOPs to optimize workflows.
• Train U.S. marketing, sales, and medical affairs teams on regulatory compliance.

Skills

FDA regulations expertise

PromoMats (Veeva)

Regulatory strategy

Cross-functional collaboration

Executive communication

Education

Bachelor’s degree

PhD/MD/JD preferred

Tools

Veeva Vault PromoMats

Job description

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.

Director Regulatory Affairs, Advertising and Promotion

Key Responsibilities

• 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.
• 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.
• 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).
• Minimum 10 years in pharmaceutical or biotechnology regulatory affairs.
• At least 7 years focused on U.S. 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.

Pay Range: The expected salary range for this position based on the primary location of Radnor, PA is $213,390-$248,955. 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.

Benefits

• Equity in the form of stock options and/or restricted stock units.
• Comprehensive health insurance.
• Dental insurance.
• Vision insurance.
• Life and disability insurance coverage.
• 401(k) retirement benefits with employer match.
• Learning and wellness stipends.
• Paid time off.

#LI-HYBRID

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.

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.

Cytokinetics is an Equal Opportunity Employer

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.