Director, Regulatory Affairs

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, competiti...