Director, Regulatory Affairs

Merz Pharmaceuticals LLC; Raleigh (NC); On-site; USD 180,000 - 260,000; Full time

Job summary

Merz Therapeutics in the United States seeks a Director of Regulatory Affairs to lead a team of regulatory professionals. You will guide development and lifecycle strategies for new products, oversee submissions, and ensure compliance with US FDA regulations.

Collaboration with Marketing and Legal is essential to manage regulatory impact on business strategy. The role requires extensive experience in regulatory affairs, people management, and a background in INDs/BLAs/NDAs, with preference for

Qualifications

• Minimum 10 years regulatory experience
• Direct experience with development, preparation and submission of INDs, BLAs, and NDAs
• Strong knowledge of US drug and biologic regulatory environment and FDA regulations
• Previous experience managing people
• Experience with EU/International Regulatory preferred

Responsibilities

• Act as mentor and coach for staff on regulatory activities
• Develop and execute global regulatory strategies for development and lifecycle projects
• Coordinate regulatory submissions planning and preparation
• Maintain national registrations, licenses, listings and other certifications
• Review labeling for regulatory compliance and liaison with agencies
• Provide regulatory intelligence and risk assessments to leadership
• Coordinate pharmacovigilance activities and FDA audits as needed
• Manage regulatory resources including budget and FTE
• Perform other duties as assigned

Skills

Regulatory strategy

People management

IND/BLAs/NDAs

FDA regulations

Education

Bachelor's Degree in science/health

Master's degree preferred

Job description

Step into the future with us at Merz Therapeutics, where our family roots meet a bold new vision. Together, we're embarking on a transformative journey, blending time-honored traditions with exciting new products. 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 with 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! #IAmMerz Are you ready to galvanize a team around a culture of care, putting patients first to spark change? The Director, Regulatory Affairs leads a team of regulatory professionals and is accountable for the regulatory affairs deliverables under their supervision. Position provides guidance on the development and execution of regulatory strategies for new products and oversight of lifecycle management of existing products. Position supports Marketing and Legal teams on regulatory issues with potential business impact, including participating in Promotional Review Committee.

Essential Duties & Responsibilities

Project/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.

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.

Labeling

• Work with Commercial and R&D colleagues to develop 'best in class' labeling.
• Review product labeling for regulatory compliance.

Liaise 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.

Pharmacovigilance

• Work with direct reports to ensure accurate processing and timely reporting of safety information related to drug products from all sources, in compliance with SOPs and US regulations.
• Participation in and coordination of any FDA audits of safety information.

Management

• Mentor and provide guidance to staff. May 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.

Other duties as assigned.

Education

• Bachelor's Degree in scientific or health discipline required.
• Master's degree in scientific or health discipline preferred.

Professional 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 required.
• Experience with EU/International Regulatory 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 [e-mail]