Why join Cardurion Pharma?

We are a clinical-stage biotechnology company discovering and developing new therapeutic approaches to treat cardiovascular disease.  We have built a pipeline of novel therapeutic product candidates that have the potential to address the significant morbidity and mortality that remains for patients suffering from cardiovascular disease.  We invite you to explore our website to learn more about our Company and how we are advancing towards our goal of building a world-class biotechnology company that discovers, develops and commercializes life-changing therapeutics for patients with cardiovascular disease. 

The Role:

Reporting to the Global Head of Regulatory Affairs, the Senior Director will provide regulatory leadership for assigned programs, which includes developing global regulatory strategies as a key member of the global program team. This individual will serve as the global regulatory lead (GRL) for assigned programs from pre-Phase 1 through marketing application approvals.  The ideal candidate will have a strong background in regulatory affairs, exceptional leadership skills, and a passion for making a difference in the lives of patients. 

Key responsibilities: 

• Develop and implement regulatory strategies for assigned programs in support of product development and eventual registration in alignment with overall business objectives.
• Ensure high-quality and timely regulatory submissions (IND/CTA/NDA/MAA/etc, as applicable) in compliance with all applicable regulatory requirements and in alignment with company goals.
• Share expertise and offer guidance to teams and management on global regulatory requirements, standards, and guidelines to ensure regulatory requirements are met for development programs. Analyze and communicate changes in the regulatory environment to teams and the broader organization as relevant to development activities.
• Provide leadership and oversight for the preparation of all global regulatory submissions (from pre-IND through post-marketing) to the FDA, EMA, and other international health authorities. Monitor and track the progress of regulatory submissions and      communicate any potential issues or delays to senior management.
• Proactively identify and communicate regulatory risks and mitigations associated with development strategies. 
• Collaborate effectively with cross-functional teams to ensure alignment and compliance with regulatory requirements.
• Represent regulatory in senior management discussions and present strategies, regulatory recommendations, and risks as needed.
• Act as the primary liaison with regulatory authorities for assigned programs.
• Direct and assist internal regulatory staff and external regulatory consultants, as needed, in support of development activities for assigned programs. 
• Support due diligence and partnering activities as needed.
• Drive continuous improvement initiatives to enhance regulatory processes, systems, and capabilities.
• 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 package including: Blue Cross Blue Shield PPO, Delta Dental, and VSP vision 
• Fully funded HSA for high-deductible PPO Plan
• 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
• Flexible Spending Accounts for medical and dependent care expenses
• 4 weeks Paid Time Off annually 
• 11 company paid holidays and Year-End shut down 

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.

Qualifications:

• BS in scientific discipline or equivalent experience (advanced degree preferred).
• Minimum of 12 years’ Regulatory Affairs experience in Biotech, Pharma or Clinical Research Organization with a minimum of 10 years in a Regulatory Strategy role
• Working knowledge of relevant FDA, EU, ICH guidelines and regulations and direct experience with global development programs in US and EU (experience in other regions would be beneficial).
• Significant experience in a regulatory leadership (GRL) role on program teams and in developing and implementing successful global regulatory strategies for programs.
• Proven track record of interfacing and negotiating with health authorities. 
• Experience working with CROs, vendors/consultants, and relationship management preferred.
• Comfortable working in a complex, matrix, cross functional environment with multiple stakeholders
• Ability to lead teams under tight timelines and      be willing to contribute significantly to day-to-day operations as needed
• ·Excellent communication and interpersonal skills.
• 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.
• Ability to travel to key meetings as needed.