VP Regulatory Affairs and Quality Rhythm Pharmaceuticals
The launch and commercialization periods for a new product are exciting times for any company. The role of regulatory in new product development involves managing high organizational complexity and diverse stakeholders. When the long, difficult, and costly development process is finally coming to fruition, hopes are high, and the pressure is on for successful product approval and launch. The handover process from approval to market requires close regulatory compliance oversight for a smooth transition. The commercialization process is fraught with complex challenges, including post-market surveillance, market access barriers, supply chain challenges, and many other risks. If mishandled, these can result in missed opportunities for patients and potential loss of market share. A robust patient-centric life cycle strategy must include an integrated global regulatory framework from the beginning. For optimal efficiency, regulatory and commercial operations must work closely to meet the patient and business needs.
Regulatory leadership and compliance oversight are essential in product life cycle management in both pre-approval and post-approval stages of development. Clinical, economic, and marketing deliverables at each stage of product development must adhere to legal and regulatory requirements, processes, and internal company policies to optimize quality and regulatory best practices.
From a program leadership perspective, the regulatory and compliance functions should partner with the commercial function to enable optimal cross-functional interactions on the product launch leadership team. Coupled with a robust risk management framework, this partnership will increase the success of product launch and commercialization for the benefit of patients and align with the organizational goals. This approach will result in a strategic partnership between regulatory and commercial, creating a roadmap for commercial success.
Describe how regulatory oversight guides the product development life cycle from pre-approval to post approval.
Explain a partnership between regulatory and commercial operations results in successful strategic execution of commercial strategies to minimize time to market and maximize both patient outcomes and brand performance.