VP, Regulatory Affairs

Description

The Vice President, Regulatory Affairs, will provide leadership and oversee regulatory activities for Prelude. This includes providing strategic as well as operational leadership and for managing the personnel and activities of the regulatory affairs team. The VP, Regulatory Affairs will ensure development and execution of regulatory strategies and submission plans. The VP, Regulatory Affairs will ensure compliance with regulatory requirements for products under development.

• •Manage a team of regulatory professionals to develop and execute Prelude’s regulatory strategy
• •Provide regulatory guidance to cross-functional groups regarding all aspects of preclinical and clinical development and testing for products
• •Direct efforts for planning and execution of required regulatory filings
• •Works with project teams to resolve complex project issues. Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained.
• •Prepare company team for FDA and other health authority meetings
• •Ensure oversight and manage RA department interface with the FDA and other regulatory authorities in an optimal manner
• •Represent regulatory affairs on the extended leadership team and at cross-functional teams
• •Communicate regulatory risk assessment to senior management and propose mitigation approaches
• •Provide critical review of documentation supporting regulatory applications including, but not limited to, pre-IND and formal meetings with health authorities, INDs, Clinical Trial Applications, Annual Reports, BLAs, NDAs, MAAs, Variations and BLA supplements
• •Ensure progress for the assigned area of responsibility and provide routine progress update to functional and business unit management
• •Maintain knowledge of global regulatory environment, regulations and guidances.
• •Monitor applicable current and new regulatory requirements and interact with company partners and consultants for regulatory matters as needed
• •Contribute regulatory perspective as needed on government proposals and external due diligence activities
• •Contribute to the modification, development and implementation of company policies and procedures for regulatory affairs

Requirements

Education

PhD or master’s degree w/ equivalent relevant experience required.

Experience

15+ years of industry experience in Regulatory Affairs for products in product development and post licensure settings.

Specific Skills

• •Knowledge of global regulations /guidances and thorough knowledge of drug development process required. Knowledge of small molecule regulations desired
• •Strong strategic and critical thinking, diplomacy, negotiation and excellent oral and written communications skills.
• •Ability to understand and apply technical materials and regulations, strong technical writing skills, knowledge of CMC, clinical and non-clinical pharmaceutical development,
• •Possess a broad knowledge of biopharmaceutical manufacturing and operations.
• •Experience with international regulatory submissions strongly preferred, knowledge of Chinese regulations a plus.