Director of Regulatory Affairs at Merz Pharmaceuticals, LLC in Raleigh, North Carolina

Job Description:

** This role is in Raleigh, NC. We are considering candidates open to relocation. It is onsite 3 days/remote 2 days/wk** Who We Are: Harvesting Hope with a Growing Family At Merz Therapeutics, we take a nurturing approach to our organization - treating colleagues like family, embracing our whole selves and creating a company culture that encourages growth and decisive action. We are committed to caring for whole communities by focusing on individuals suffering from movement disorders and neurological conditions and the healthcare providers dedicated to helping them, while simultaneously bolstering our team members in a united effort to make a difference. As a private, family-owned company, we have the liberty and support to make decisions for ourselves, our customers and the patients we serve. We pride ourselves on building an inclusive culture where there is room to celebrate individual growth and the ability to contribute to a common good as a collaborative team. Our mission is grounded in a long-term view of making a difference for the common good, while growing together as a family. If you're looking to immerse yourself in a passionate team rooted in community, connection and camaraderie, then we're looking for YOU! #IAmMerzTx Are you ready to galvanize a team around a culture of care, putting patients first to spark change? The Director of Regulatory Affairs leads a small team of regulatory professionals and is accountable for the regulatory affairs deliverables under their supervision. This position will also function as a Global Regulatory Lead on Global Project Team for development of new indications for key portfolio products. The position provides guidance on the development and execution of regulatory strategies for new products and oversight of lifecycle management of existing products. This position supports Marketing and Legal teams on regulatory issues with potential business impact, including participating in Promotional Review Committee. Major dutiesDescriptionProject/Product regulatory support• Act as both an individual contributor when needed and a coach for other team members on new product development activities.• Actively contribute to the development and execution of global regulatory strategies for development and life-cycle projects.• Work with direct reports to identify, assess and communicate regulatory risks and project issues as well as recommend solutions to R&D senior management.• Act as Global Regulatory Lead (GRL) on at least one project team, working with global regulatory affairs team to provide global strategy for new indications for key portfolio product(s)Regulatory Submissions• Interact with direct reports and project team members to ensure high quality and timely regulatory submissions, which may include submission planning and preparation.• Ensure documents are in compliance with current regulations and guidance and provide strategic oversight.Sustaining Regulatory Support• Ensure all national registrations, licenses, listings and other certifications are maintained as required for regulatory compliance.• Support commercialization and maintenance activities of products as needed, including acting as primary regulatory reviewer on Promotional Review Committee.Labeling• Work with Commercial and R&D colleagues to develop 'best in class' labeling.• Review product labeling for regulatory complianceLiaise with regulatory agencies• Primary point of contact for Global Health Authorities. Communicate regulatory requirements and risks to internal stakeholders.• Interact with contract manufacturers, affiliates and distributors. Regulatory Intelligence• Conduct and analyze regulatory research providing guidance to the business and project teams on past precedence, competitive landscape and regulatory intelligence. Management• Mentor and provide guidance to staff. Manage and supervise direct reports including work assignments and performance feedback, appraisals and reviews.• Manage regulatory resources (budget and FTE) as needed.• Communicate regulatory requirements and risks to business leadership.Education-Bachelor's Degree in scientific or health disciplineRequired-Master's degree in scientific or health disciplinePreferredProfessional experience -Minimum 10 years relevant regulatory experience Required -Direct experience with development, preparation and submission of INDs, BLAs, and NDAs Required -Strong knowledge of US drug and biologic regulatory environment and FDA regulations and guidance Required -Previous experience managing people Preferred -Experience with EU/International Regulatory Preferred -Experience with Combination Products, particularly drug/device Preferred Don't meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Merz Therapeutics we are dedicated to building a diverse, inclusive, and authentic workplace, so if you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles. Recruitment Note: Merz Therapeutics only sends emails from verified "merz.com" addresses and never asks for sensitive, personal information or money. If you have any doubts about the authenticity of any type of communication from, or on behalf of Merz Therapeutics, please contact Therapeutics.HR@merz.com