Director, Regulatory Strategy

Why join Cardurion Pharma?

At Cardurion, we are advancing the understanding of the cellular mechanisms that regulate heart function and are developing new treatments to address cardiovascular disease. Our programs seek to modulate signaling pathways that regulate heart cell function to reverse the pathophysiological mechanisms that drive cardiovascular disease. We invite you to explore our site to learn more about our Company and how we are advancing the promise of cardiovascular signaling pathways science to improve health and impact lives around the world.

The Role

Reporting to the Head of Global Regulatory Affairs, the Director will be responsible for the regulatory elements of one or more cardiovascular drug development programs. In the Global Regulatory Lead (GRL) role, the individual will be the primary regulatory contributor to the program teams, oversee CRO activities in the planning, submission, approval, and maintenance of global clinical trial applications, and partner with program teams in the planning for regulatory activities/requirements to support future marketing applications.

Here’s What You’ll Do

• Collaborates with Company Management and Program/Product Development Team(s) to establish global strategies in line with applicable regulations to achieve business objectives for development products.
• Leads preparation of global regulatory product strategies and associated documents for assigned products. Identifies regulatory risks and mitigations associated with development strategies.
• Leads cross-functional stakeholders to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers, regulatory submissions, and responses to regulatory Agency requests.
• When necessary, seeks expert advice and technical support from internal functional stakeholders, manager, and external development partners (CRO) or consultants.
• Maintains awareness of new global regulatory policies, initiatives, and regulations, and shares relevant information with drug development (program) teams.
• Oversees activities of regulatory professionals supporting dossier preparations and submissions (i.e. regulatory operations, regulatory CMC, labeling) for an assigned program/product (s).
• Based on experience and scientific strengths, expands regulatory knowledge of cardiovascular TA and provides coaching and mentoring for other regulatory professionals.
• Under minimal guidance of supervisor/manager, presents meaningful regulatory assessments and regulatory recommendations to program teams and executive management, and works to ensure cross functional alignment.
• Proactively communicates to management, program team, and cross functional stakeholders of issues, potential issues, and regulatory approvals. Provides assessment of impact on global programs.
• Provides recommendations on decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management.
• Follows budget allocations and keeps supervisor informed on project resourcing (headcount-related fees, filing fees, and professional services).
• May have direct report(s) and contribute to the performance management for other RA team members.

Here’s What We’ll Bring To The Table

• Highly competitive benefits including: medical offered through BCBS PPO, Delta Dental, and vision offered through VSP
• Fully funded HSA for high-deductible PPO Plan
• Flexible Spending Accounts for medical expenses and dependent care expenses
• 4 weeks Paid Time Off annually
• 10 company paid holidays and Year-End shut down
• 401k (traditional and Roth offered) with 100% match on first 4% deferred. Match is vested immediately
• A suite of Cardurion paid insurance coverage, including: life insurance, short-term and long-term disability

Our Mission:

Translate our world-class expertise in cardiovascular signaling pathways into groundbreaking therapeutics for patients.

Cardurion is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Cardurion will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Requirements

Here’s What You’ll Bring to the Table:

• BS in scientific discipline (advanced degree or certifications preferred) and minimum 10 years Regulatory Affairs experience in Biotech, Pharma or Clinical Research Organization with a minimum of 5 years in a Regulatory Strategy role
• Working knowledge of relevant FDA, EU, ICH guidelines and regulations and direct experience with clinical development programs in US and EU (experience in other regions would be beneficial).
• Proven 3-5 years in a leadership (GRL) role with strong management skills.
• Experience interfacing and negotiating with government regulatory agencies.
• Experience developing and implementing successful global regulatory strategies. Strong clinical foundation preferred; CMC experience would be beneficial.
• Experience working with CROs, vendors, and relationship management preferred.
• Experience working in a complex, matrix, cross functional environment, and with multiple stakeholders.
• Outstanding communication skills (verbal and written).
• Ability to manage multiple projects in a fast-paced environment.
• Ability to easily pivot between short- and long-term strategic planning, while directly contributing to real-time regulatory and development team initiatives.
• Strong business acumen and able to work under pressure.