Sr. Director, Regulatory Affairs

Currax Pharmaceuticals LLC is a specialty pharmaceuticals company focused on providing increased access to life- changing medications for patients and healthcare providers. We seek to improve patient health and quality of life through the acquisition and commercialization of medications, including Contrave, Mysimba, Silenor, Treximet, ONZETRA Xsail, and a portfolio of generic medications.

At Currax, we take pride in our mission to serve patients, and we value authenticity and collaboration in our workplace. As we experience an exciting period of accelerated growth, our organization is rich with opportunities for our people to gain hands-on experience and fulfill career aspirations while making a direct impact on the lives of patients we serve.

About the Role

The Sr. Director, Regulatory Affairs reports to the SVP, Chief Medical Officer and is primarily responsible for leading the Regulatory Affairs functions for Currax Pharmaceuticals LLC. They will ensure appropriate support for program maintenance, post-marketing studies and development programs by direct 'hands-on' work or supervision and direction of in-house and contract staff. Provide direction to assigned programs by overseeing or coordinating all aspects of regulatory strategy, agency interactions, approved drug maintenance, and submissions pertaining to these regions. Identify overlap and redundancies with the US/FDA filings and ensure coordinated submissions. Provide regulatory guidance and support for existing and ongoing business development functions and partnership alliance management.

Responsibilities

• Provide input into assessments of emerging regulatory trends and precedents as to their potential impact to the business.
• Provide regulatory affairs project management including timelines and tracking of ongoing regulatory activities and supporting departmental budgeting activities.
• Review key documents (e.g., clinical study protocols, labeling etc.) to ensure adherence to regulatory requirements and guidance's and GCP quality standards.
• Manage submission activities (e.g., IND/CTA and amendments, NDA, MAA, DMF) and health authority interactions (meeting requests and briefing documents), ensuring adherence to regulatory project timelines. Ensure close collaboration with Quality Assurance and Regulatory CMC staff.
• Provide oversight and management of external regulatory and development vendor resources.
• Serve as a key primary point of contact with FDA/EMA regulatory project manager.
• Provide oversight of company documents and document systems supporting development activities.
• Ensure adherence to Regulatory Affairs budget and achieving company regulatory goals according to agreed timelines and with a high level of quality.
• Support business development activities including regulatory due diligence and strategy related to portfolio lifecycle management, partnering and licensing opportunities and alliance management.
• Management and oversight of regulatory affairs aspects of commercial product labeling, commercial product packaging and supply globally.
• Oversee Global Regulatory Affairs Department staff and contractors. Inspire, manage and lead direct reports.
• Contribute to fostering a culture of collaboration and excellence.

Required Qualification & Skills

• Bachelor's Degree in a scientific or healthcare discipline preferred (advanced degree or relevant certification a plus).
• At least 10 - 15+ years' experience in pharmaceutical regulatory affairs with significant experience in global regulatory affairs activities.
• Broad knowledge of global health authority regulations, guidelines, "best practices" and the ability to interpret applicability to specific products.
• Excellent communication (verbal, written, and presentation) and interpersonal skills.
• Detail-oriented with a sharp eye for content and quality.
• Excellent planning, organizational, and decision-making capabilities.
• Must be able to balance multiple or changing priorities and resolve problems independently.
• Expertise in core computer software applications (MS Office) as well as technical requirements for electronic regulatory submissions (e.g., eCTD).
• Must be willing to travel (up to 20%) domestically or internationally as needed.

Currax Core Values

• Integrity
• Passion
• Accountability
• Commitment
• Teamwork

Currax is committed to the health and well-being of our employees and families and offers a comprehensive benefits package. Available benefits include medical, dental, and vision coverage, 401(k) plan with company match, paid time off and holidays, and other benefits to support your physical, financial, and social well-being.

Currax Pharmaceutical LLC does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact Human Resources at human.resources@curraxpharma.com Read our full EEO statement at http://www.curraxpharma.com/careers/eeo-statement/