Vice President, Regulatory Affairs

VP Regulatory Affairs

Cambridge, MA - United States

Summary:

Seeking a proven leader to join a small Regulatory team as Vice President Regulatory Affairs to oversee the global regulatory process for all products. This leader will serve as the main point-of-contact for US and international health authorities and will be the key executive to help the growth and success of the group. This role is highly visible, and the VP will manage and provide strategic leadership for regulatory strategy, agency interactions, and submissions for US FDA, EMA, and other key markets Health Authorities. This position is strategic, providing the vision and direction for the regulatory group.

• Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals in the US market.
• Expert knowledge of clinical development and the US and Global regulatory strategy.
• Early development and lifecycle management experience with broad therapeutic area experience preferred, especially immuno-oncology drug development.
• Assist in clinical studies required for regulatory approvals, including clinical study design, data analysis, and data reduction.
• Direct and coordinate activities with the company and management's goals and objectives.
• Represent as the main point-of-contact before all regulatory authorities.
• Provide overall review, day-to-day management, and operational success for all regulatory functions including the successful integration of activities cross-functionally.
• Assist the team, provide training and interpretations of the FDA and other regulatory issues, and assist as a liaison between the organization and appropriate regulatory authorities.
• Support the group and oversee all regulatory filings; lead the regulatory activities for all products, including pre-market and post-market requirements.
• Proven ability to lead multidisciplinary teams towards common goals through development/approval challenges by managing and building consensus among multiple stakeholders.
• Successful track record of working in a matrix organization while building strong partnerships with other organizations including R&D, Manufacturing, and Senior Management Team.
• Strong and demonstrated leadership skills, problem-solving ability along with associated analytical and communication skills.
• Proven experience in leading and managing regulatory affairs and QA functions through teamwork, collaboration, and open communications.
• Must have a solid understanding of FDA regulations and ICH guidance, as well as a comprehensive knowledge of the drug development process.

Qualifications:

• An advanced scientific degree (Ph.D.) highly preferred with 10+ years in the pharmaceutical industry, including 5-10 years of direct management experience leading regulatory responsibilities in a commercial organization.
• Strong US and Global regulatory affairs experience with in-depth knowledge of clinical development and regulatory strategy, as well as preparation and successful execution of health authority interactions.
• Minimum of 7 years of regulatory experience within the drug development and approval process in INDs, CTA, and marketing applications