Regulatory Strategy Manager - Immunology

About the role

Responsible for supporting regulatory strategy execution for development programs. Works closely with the Director of Regulatory Affairs to prepare regulatory submissions (strategy, authoring, timeline planning, etc.) and to maintain department regulatory processes. Coordinates, prepares, and contributes to the development of document packages for regulatory submissions including IND/CTA, NDA/BLA. DSUR/Annual Reports, clinical protocols, clinical study reports, application amendments and postapproval activities.

Ensures submission compliance with local and regional regulatory requirements, company policies, and internal quality and compliance standards. Provide regulatory representation on cross-functional teams as directed. Collaboratively develop regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs.

Provide regulatory review of clinical study documentation, including review of clinical protocols, informed consent documents, clinical study recruitment materials. Perform regulatory research and communicate new/emerging regulations to management and project teams.

Requirements

• BS/BA degree in Life/Health Sciences AND 6+ years of industry experience of which a minimum of 3 years must be Regulatory Affairs experience in drug development at a research-based pharmaceutical company, including two years in a lead capacity. Experience with FDA regulations and ICH guidelines for regulatory submissions.
• OR Master’s degree in Life/Health Sciences preferred AND 4+ years of related experience OR PharmD or PhD AND 2+ years of related experience
• Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
• Works to improve tools and processes within functional area.
• Developing reputation inside the company as it relates to area of expertise
• Ability to work as part of and lead multiple teams
• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
• Excellent computer skills
• Excellent verbal and written communications, problem-solving, analytical thinking skills
• Sees broader picture, impact on multiple departments/divisions
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent project management skills
• Thorough understanding of FDA regulations and ICH guidelines for regulatory submissions
• Demonstrated understanding of laws, regulations, standards, and guidance governing drug development (e.g., US regulatory knowledge) a plus

Skills

Develop, review and/or file INDs, CTAs, briefing documents and maintenance of development and approved applications including authoring DSURs, annual reports, amendments as needed

Provide regulatory representation and expertise on cross-functional teams and CRO-led meetings. Act as the regulatory lead for clinical trials at various stages of development, providing strategic regulatory guidance and ensuring alignment with project objectives

Collaboratively develop global regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs

Maintain an awareness, through regulatory intelligence, of global regulatory strategies for products in the same class/indication and determine applicability to Company programs

Develop and manage project timelines for regulatory submissions

Lead, coordinate, author, critically review and provide strategic input on regulatory filing documents

Provide regulatory assistance and review of clinical study documentation, including review of clinical protocols, informed consent documents, and clinical study recruitment materials

Conduct regulatory research and analysis, develop and communicate recommendations regarding new/emerging regulations to management and project teams

Develop and maintain standard operating procedures and department working practices

Ensures the company is adhering to all applicable government regulations

Complete assigned activities with the project team

Other duties as assigned