Job Description:
As Associate Director Clinical Regulatory Scientist, you will develop and execute the regulatory strategy for the US and Canadian market.
Key Responsibilities:
* Develop, Update and Execute US and Canada Registration Strategy
* Initiate and Update Regulatory Strategy Document
* Assist or lead in the development of regulatory strategy by leveraging scientific, drug/device clinical development and knowledge from FDA/HC meetings and regulatory trends
* Integrate information from the external environment, product specific regulator advice, and other public information (i.e., Advisory Committees) to develop robust, innovative regulatory strategies
You will review, summarize, and present information regarding regulator expectations by utilizing agency feedback received by the organisation and knowledge of competitor labelling. You will also monitor upcoming and recent approvals of competitive development programs/plans and integrate US/CA regulatory strategy into global registration strategy.
Furthermore, you will partner with colleagues across regulatory functions to deliver integrated US/Canada regulatory strategy and communicate key information to enable seamless execution of US/Canada regulatory strategy. You will provide input to clinical program to support market differentiation needs and communicate the regulatory options and impact on proposed product development plans, seeking Senior Regulatory Scientist and management alignment.
Additionally, you will leverage innovative regulatory strategies with accompanying required data to accelerate asset development while enabling market differentiation of first-in-class/best-in-class assets. You will collaborate with internal teams for the success of the pricing and access strategies through influencing what data is needed and how it is collected on development or product lifecycle planning.
Moreover, you will support development and update of labelling strategy to deliver market differentiation and initiate and update Claims Mapping, and Labelling Dashboard. You will partner with regulatory, product and clinical development, commercial and project personnel to drive a Market Differentiation as Driver Strategy using available tools and resources (e.g., Claims mapping) and network for alignment.
Requirements:
* Bachelors degree in scientific or health sciences discipline
* Industry-related experience in regulatory affairs and/or drug development experience for minimum of 5-8 years
* Knowledge of FDA and Health Canada procedures and practices across Review Divisions and awareness of evolving regulatory reform initiatives desirable
Demonstrated deep knowledge of the drug development process, regulatory/business strategies and plans required. Demonstrated ability to assess and manage risk in a highly regulated environment. Demonstrated strong written, spoken and presentation communication skills, negotiation and influence skills, attention to detail, and effective teamwork skills; able to adapt to diverse interpersonal styles.