New · posted Oct 15
Cytokinetics · Pharmaceuticals
Director, Regulatory Affairs
- South San Francisco, CA
- Hybrid
- Full-time
- Director
Open until filled
The role
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.
Reporting to the Senior Director, Regulatory Affairs, the Director, Regulatory Affairs is responsible for leading regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international development strategies.
What you need
- 10+ years of drug development, including at least 7+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry; experience in small molecule drug development is preferred; experience in the cardiovascular therapeutic area is a plus
- Bachelor’s degree is required, preferably in a scientific discipline; advanced degree (MD, PharmD, or PhD) is a plus
- Excellent working knowledge of international regulatory requirements and environment applicable to the clinical development and post-marketing space, including an understanding of GXP
- Demonstrated knowledge of the regulatory requirements in the design and conduct of clinical trials, including the preparation of regulatory submissions
- Experience with eCTD requirements and electronic submissions
- Experience with international regulatory submissions and processes (eg, Canada, greater China, Japan) is a strong plus
- Demonstrated management expertise, including leadership and development of employees
- Ability to work effectively across teams, functions and with external partners
- Excellent oral and written communication skills
- Excellent organizational and time management skills, attention to detail, and ability to independently drive deliverables to completion
- Ability to work effectively in a fast-paced environment while managing multiple priorities
What you'll do
- Formulates regulatory strategies, with supervisor oversight, to support program objectives and oversees implementation of regulatory strategy and activities needed to secure approval of new drugs
- Serves as a regulatory affairs lead on assigned clinical studies to support the development and execution of global regulatory strategies and provide regulatory advice to other functions
- Identifies gaps in product development plans that may pose regulatory risks and identifies related solutions and mitigation plans
- Builds and maintains collaborative relationships with cross-functional project teams, other departments, vendors, and external business partners to achieve program regulatory goals
- Manages coordination, preparation, and timely submission of regulatory documents, filings, and responses to queries
- Reviews global regulatory submissions for consistency and quality across regions
- Maintains current knowledge of laws, regulations and guidelines (eg, FDA, EMA, ICH, CDE, PMDA), as needed to support global programs
- Ensures conformance to commitments made with various regulatory agencies (eg, IND/CTA commitments, annual obligations) for assigned programs
- Contributes to regulatory department initiatives, including the development and maintenance of internal regulatory processes, operating guidelines, templates, and best practices
- Supervises employees, consultants/contractors, and/or interns in Regulatory Affairs
- Mentors department personnel and optimizes employee performance by developing employees and promoting career growth
Pay
$225,000 – $262,500 a year
Employer providedIn the U.S., the hiring pay range for fully qualified candidates is $225,000 - $262,500 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.
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.
Where you'll work
South San Francisco, CAHybridOpen in Maps (opens in a new tab)
More jobs in South San Francisco, CAEqual opportunity, accessibility and legal noticesCytokinetics's statements, word for word
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 [email protected]
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 4% above the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Director roles in California21 roles publishing pay
Director roles in the US101 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $225,000 | — | $262,500 |
| California (middle half) | $223,000 | $244,000 | $282,500 |
| All US (middle half) | $209,500 | $235,000 | $264,000 |
This role: Cytokinetics's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Cytokinetics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions7
- Collaboration and leadership6
- GMP and compliance2
- Documentation and SOPs1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAeCTD(official source, opens in a new tab)The electronic Common Technical Document format for submissions
Company hiring pulse
Cytokinetics on Regulatory Jobs
- 12
- Open roles
- 11
- Distinct roles
- 2
- Locations
By discipline
- Regulatory6 50%
- Quality4 33%
- Compliance & Safety2 17%
By level
- Director5 42%
- Manager5 42%
- Senior & Principal2 17%
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Director, Regulatory Affairs at Cytokinetics
Open until filled. $225K–$263K a year, employer provided.