LOCATION - CORK: IRELAND

Regulatory & Drug Development Expertise

• Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards, of CMC RA submission processes, electronic submission regulations and guidance regarding structure requirements to CMC development teams regarding global CTAs and registration dossiers. Responsible for preparing CMC CTD content consistent with approved manufacturing changes, technical reports and procedural requirements.
• Partner with the CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products.
• Partner with the CMC RA Scientist to drive the execution of submission planning for global registration and maintenance submissions.
• Responsible for triage of company's affiliate inquires and requests and when necessary, consults with CMC RA Scientist for guidance in effort to prepare responses to questions.
• Implement and in some cases interpret global regulations and guidance’s and look to regulatory precedence into submission processes and publishing standards to ensure final document content and structure are aligned with local regulatory requirements. Partner with company's affiliate regulatory staff, as necessary, to gain alignment on establishing new submission standards to meet local agency requirements.

Lead, Influence, Partner

• Create an environment within the Global Regulatory Area and across CMC development teams that encourages open discussions on issues to achieve a robust outcome on project decisions. Constructively challenge teams to reach the best solutions to issues.
• Leverage internal forums to continue to develop and share regulatory and drug development expertise to meet critical product registration timelines and electronic submission structure and content requirements.
• Communicate effectively to guide and influence within work group/function and with development team regarding life-cycle management processes
• Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues across multiple functions and geographies.

Minimum Qualification Requirements:

• Bachelor’s Degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related scientific discipline)

Other Information/Additional Preferences:

• Drug development process / Industry-related experience
• Knowledge of Agency submission procedures and practices. Knowledge / awareness of emerging submission electronic standards.
• Ability to operate and manage operational requirements in a regulated environment
• Negotiation and influence skills
• Attention to detail and ability to effectively prioritize
• Proven effective teamwork skills; able to adapt to diverse interpersonal styles.