About the job
Cytokinetics is a late-stage 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 muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility.
Reporting to the Senior Director, Regulatory Affairs, the Director of Regulatory Affairs, Advertising and Promotion, is responsible for leading commercial regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international promotional strategies. This role can be Remote in the US or located in our South San Francisco office or our Radnor PA office.
- Provide commercial regulatory guidance to assigned products and/or therapeutic areas and collaborates with relevant stakeholders to ensure business objectives can be achieved in a compliant manner
- Develop and guide implementation strategies for promotional activities
- As a member of the Promotional and Medical Review Committees, provide strategic regulatory input during new concept reviews, and reviews and approves materials for regulatory compliance
- Guides and 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
- Formulate regulatory strategies, with supervisor oversight, based on current regulatory intelligence and scientific knowledge
- Serve as an assigned contact to and maintains a positive relationship with the US FDA Office of Prescription Drug Promotion (OPDP)
- Provide promotional regulatory strategy and prepares submission of materials at the time of dissemination (Form FDA 2253) or for advisory comment requests
- Maintain 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
- Ensure conformance to feedback from various regulatory agencies (eg, OPDP advisory comments) for assigned programs
- Build and maintain collaborative cross-functional relationships to achieve project regulatory goals and to ensure effective communication regarding issues and timelines
- Build and maintain relationships with external vendors, business partners (when applicable), and regulatory health authorities
- May supervise employees, consultants/contractors and interns in Regulatory Affairs
- Identify, develop and implement regulatory operating guidelines and common work practices/strategies within the team
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.
- Bachelor’s degree with 12+ years of related experience
- In-depth 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
- Experience with labeling and packaging is a plus
- Ability to work effectively and influence others across teams, functions and with outside partners
- Excellent oral and written communication skills, including the ability to provide creative solutions based on judgement and analysis of the issues
- Excellent organizational skills and attention to detail
Salary pay range: $212,000 – $259,000. 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 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