Regulatory CMC Associate
Join a global pharma company based in Cork as they seek a Regulatory CMC Associate to contribute to their team on a permanent basis with hybrid working.
As a key member of the Regulatory CMC team, you will collaborate with the CMC Regulatory Affairs Scientist to lead various aspects of global marketing authorization submission management processes.
You will assist in providing guidance on structure and content placement within CTD registration submissions and support the preparation of submission-related Ministry of Health responses.
Responsibilities:
* Lead CMC submission management process by leveraging knowledge of CMC regulatory requirements, including ICH CTD and evolving global agency standards. Partner with CMC development teams to ensure global CTAs and registration dossiers meet regulatory standards.
* Collaborate with the CMC RA Scientist to plan and prepare submission content for clinical studies and manufacturing process changes.
* Drive the execution of submission planning for global registration and maintenance submissions, ensuring alignment with local regulatory requirements.
* Respond to global inquiries and requests, consulting with the CMC RA Scientist as needed to prepare accurate responses.
* Implement and interpret global regulations and guidance, applying regulatory precedence to submission processes and publishing standards.
* Create an open environment that encourages discussion and collaboration among Global Regulatory Area staff and CMC development teams.
* Develop and share regulatory expertise through internal forums to meet critical product registration timelines and electronic submission structure and content requirements.
* Effectively communicate with work groups, development teams, and stakeholders regarding life-cycle management processes.
* Demonstrate strong problem-solving skills and ability to address regulatory issues across multiple functions and geographies.
Requirements:
* Bachelor's Degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related scientific discipline).
* Knowledge of pharmaceutical drug development or industry-related experience preferred.
* Experience in drug development processes or industry-related roles.
* Understanding of Agency submission procedures and practices.
* Awareness of emerging submission electronic standards.
* Ability to operate in a regulated environment.
* Strong written, spoken, and presentation skills.
* Negotiation and influence skills.
* Attention to detail and effective prioritization abilities.
* Proven teamwork skills and adaptability in diverse interpersonal settings.