VP, Regulatory Affairs

Prelude-Therapeutics-Incorporated; Wilmington (DE); On-site; USD 250,000 - 360,000; Full time

Job summary

Prelude-Therapeutics-Incorporated seeks a VP of Regulatory Affairs to lead regulatory strategy and team activities across development programs. You will guide cross-functional groups in preclinical and clinical development, and manage interactions with the FDA and global health authorities.

You will shape submission plans, ensure compliance with evolving regulations, and drive strategic regulatory direction for products in development and post-licensure settings.

Qualifications

• PhD or Master’s degree w/ equivalent relevant experience required.
• 15+ years of industry experience in Regulatory Affairs for products in development and post licensure settings.
• Strong knowledge of global regulations, drug development processes and regulatory guidance.
• Excellent written and oral communication, strategic thinking and diplomatic skills.
• Experience with international regulatory submissions strongly preferred, knowledge of Chinese regulations a plus.

Responsibilities

• Provide leadership to develop and execute Prelude’s regulatory strategy.
• Oversee regulatory guidance to cross-functional groups for preclinical, clinical development and testing.
• Direct planning and execution of regulatory filings (INDs, NDAs, BLAs, MAAs, variations).
• Interact with FDA and other health authorities, prepare meetings and communicate risk mitigation.
• Maintain knowledge of global regulatory environment and evolving guidances.
• Represent regulatory affairs on leadership and cross-functional teams.

Skills

Regulatory strategy

Global regulations

CMC knowledge

Technical writing

Cross-functional leadership

FDA/Health authority meetings

Education

PhD or Master’s degree w/ equivalent experience

Job description

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.