Associate Director, Global Regulatory Sciences - CMC

About the role

The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a product's lifecycle. Members of the organization develop global regulatory CMC strategies and partner with key stakeholders to execute the strategies in alignment with business priorities.

Responsibilities

• Represent regulatory CMC on and/or lead matrix teams for small molecules, biologics, combination and device, cell therapy products development and/or commercial products through completion of post-marketing commitments & relevant lifecycle management projects driven by research
• Independently provide strategic guidance/input related to current regulatory requirements and expectations for marketing applications, clinical trial applications for projects, and/or lifecycle changes to marketed products
• Independently manage and prioritize multiple complex projects
• Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversight from supervisor on complex topics
• Identify, communicate and propose resolutions to routine/complex issues
• Interpret global regulations and guidance. Identify regulatory opportunities and risks
• Provide strategic CMC regulatory expertise for development project teams
• Provide strategic input to development & GO teams to mitigate drug supply issues
• Interpret global regulations and guidance
• Communicate with project teams; with regards to technical issues that may impact regulatory submissions, strategy, or success
• Provide technical teams insight into regulatory health authority expectations
• Identify potential risks and help technical teams to formulate mitigation strategies to ensure regulatory success
• Anticipate and communicate possible regulatory paradigm shifts
• Participate in product fact finding meetings
• Review and provide regulatory assessments on change controls
• Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents
• Utilize electronic systems for dossier creation and tracking
• Support the preparation of CMC policies and procedures
• Maintain oversight and promote the highest standards of regulatory compliance by actively monitoring and verifying timely and accurate data entry into the Regulatory Information Management system within designated timeframes
• Looks for opportunities for continuous improvement in processes and technology solutions
• Participate in/lead teams to assess and educate on global regulatory landscape (e.g., review new policy for comment) and determine impact on global regulatory strategy

Qualifications

• Minimum BA/BS Degree
• 8+ years Pharmaceutical industry experience – prefer knowledge of small molecules, biotechnology or cell therapy products, including multi-disciplined experience, 5+ years CMC regulatory strategy
• Knowledge of CMC regulatory requirements for advanced therapies and/or small molecules, biologics, and cell therapy during development and post-approval as applicable
• Knowledge of pharmaceutical development, including advanced therapies and/ or small molecules, biologic, and cell therapy upstream and downstream processes, analytical methods, and small molecule or biologic/device combination, cell therapy products as applicable
• Expertise in the biological, cell therapy and/or small molecule modalities, drug development process and analytical methods, preferred as applicable
• Inter-dependent partnering skills, team-oriented and ability to influence outcomes
• Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance
• Must be able to innovate, analyze and solve problems with minimal supervision and attention to details
• Looks for opportunities for continuous improvement
• Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional, and geographic boundaries to achieve company goals
• Communicates opinions, facts and thoughts with clarity, transparency, and honesty
• Experience applying project management techniques within teams. Experience in effectively managing meetings
• Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives
• Demonstrated ability to facilitate issue resolution and conflict management, to negotiate and influence others; ability to drive quality decision making, to organize and prioritize tasks and negotiate
• Demonstrated ability to coordinate global activities
• Ability to identify, communicate and resolve complex issues
• Prepare and manage filings and ensure thoroughness, accuracy and timeliness
• Ability to interpret global regulations and guidance
• Strong oral and written skills
• Proficient with electronic systems

Benefits

This position may require up to 5% of travel