Senior Director, Regulatory Affairs

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.

Job Purpose

The Director of Regulatory Affairs will be responsible for leading activities of Regulatory Affairs with emphasis on global regulatory strategy and the preparation, review and submission of documents to FDA and other regulatory authorities. This position will be key in collaborations with Cytokinetics’ partners in the development of new molecules for Orphan and other diseases and the strategic coordination of multiple indications for these new molecules.

Responsibilities

• Formulates regulatory strategies, based on current regulatory intelligence.
• Oversees implementation of regulatory strategy and activities needed to secure approval of new drugs.
• Oversees coordination, preparation and timely submission of regulatory documents.
• Maintains current knowledge of regulations and guidelines (FDA, EMA, ICH, PMDA and others as required).
• Provides regulatory advice to other functional areas.
• Serves as a principal interface with reviewers from FDA and other health authorities
• Identifies gaps in product development plans that may pose regulatory issues
• Participates in regulatory due diligence activities.
  
  

Relationships

• Maintains and builds collaborative relationships with partners to improve effectiveness in regulatory strategies.
• Develops and maintains cooperative relationships with external vendors and regulatory health authorities.
• Coordinates activities for meetings with FDA, EMEA, and other regulatory authorities
• Mentors department personnel and updates appropriate departments on the current regulatory environment.
  
  

Management

• Supervises employees, consultants/contractors in Regulatory Affairs
• Optimizes employee performance by developing employees and promoting career growth.
• Develops and implements regulatory operating guidelines and common work practices/strategies within the team.
  
  

Qualifications

• 10 years of drug development and regulatory affairs experience in the Biotech/ Pharmaceutical industry.
• Experience in Orphan Drug development and approvals
• Demonstrated ability to interpret and stay current with FDA, EMA and other regulatory agency regulations and guidelines.
• Experience with eCTD requirements and electronic submissions
• Demonstrated knowledge of the regulatory requirements in the design and conduct of clinical trials, including preparation of regulatory submissions.
• Demonstrated knowledge of regulatory aspects of small molecule Chemistry, Manufacturing and Controls and quality assurance is a plus.
• Extensive experience in drug development and approval processes (INDs, NDAs, MAAs) across all phases of development.
• Experience with labeling requirements is a plus
• Advanced degree MD, Pharm.D. or Ph.D. preferred
• Demonstrated management expertise, including leadership and development of employees.
• Ability to work effectively across teams, functions and with outside partners.
• Excellent oral and written communication skills.
• Excellent organizational skills and attention to detail.
  
  

Pay Range

In the U.S., the hiring pay range for fully qualified candidates is $216,800.00 - $361,300.00 USD 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.

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