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.
As the Director of Regulatory Affairs, Advertising and Promotion, you will report directly to the Executive Director, Regulatory Affairs. Your primary responsibility will be to lead commercial regulatory support for assigned programs. You will ensure sound regulatory planning and tactical implementation of US and international promotional strategies.
Responsibilities
Leadership
- While this role is currently an individual contributor, this role may be responsible for supervising consultants, contractors, interns, or providing indirect leadership to members of cross-functional teams.
Functional Area
- Provides commercial regulatory support to assigned products and/or therapeutic areas and collaborates with relevant stakeholders to ensure business objectives can be achieved in a compliant manner. Develops and guides implementation strategies for promotional activities
- As a member of the Promotional and Medical Review Committees, provides strategic regulatory input during new concept reviews, and reviews and approves materials for regulatory compliance
- Assists Commercial Operations in establishing “best practices” for submission of promotional materials into the electronic review system and for the overall promotional material review process
- Formulates regulatory strategies, with supervisor oversight, based on current regulatory intelligence and scientific knowledge
- Serves as an assigned contact to and maintains a positive relationship with the US FDA Office of Prescription Drug Promotion (OPDP)
- Provides promotional regulatory strategy and prepares submission of materials at the time of dissemination (Form FDA 2253) or for advisory comment requests
- Maintains up-to-date knowledge and expertise with FDA regulations and guidelines with regards to advertising and promotion of pharmaceutical products and communicates significant changes to relevant stakeholders
- Ensures conformance to feedback from various regulatory agencies (eg, OPDP advisory comments) for assigned programs
- Builds and maintains relationships across functions and with external partners, including regulatory health authorities, to achieve regulatory goals and facilitate seamless communication
- Identifies, develops and implements regulatory operating guidelines and common work practices/strategies within the team
Qualifications
- Bachelor’s degree is required, preferably in a scientific discipline; advanced degree is a plus
- Deep knowledge of the regulatory requirements for compliant advertising/promotion and scientific exchange of prescription drug products, including during the investigational and post-approval phases. US regulatory experience required; ex-US regulatory experience is a plus
- Familiarity with Veeva PromoMats and Veeva MedComms preferred
- Proven experience working effectively and influencing others across teams, functions and with outside partners
- Excellent oral and written communication skills, including experience providing creative solutions based on judgement and analysis of the issues
- Excellent organizational skills and attention to detail
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
