Clinical Regulatory Associate

3 weeks ago

Cork, Cork, Ireland Scientificjobs Full time

Clinical Regulatory Associate
Our client, a global pharma company are currently recruiting for a Clinical Regulatory Associate to join their global regulatory team on a permanent basis. As Clinical Regulatory Associate you will be accountable for the US and Canada regulatory strategies that support the expedited delivery of safe and effective products to patients.

Responsibilities:

Assist the Regulatory Scientist in the development of regulatory strategy by leveraging scientific, drug/device clinical development and knowledge from FDA/Health Canada meetings and regulatory trends Review and summarize, information regarding regulator expectations by utilizing agency feedback received and knowledge of competitor labelling Monitor upcoming and recent approvals of competitive programs Communicate and share key information to enable seamless execution of US/Canada regulatory strategy Communicate the regulatory options and impact on proposed product development plans, seeking Regulatory Scientist and management alignment Leverage innovative regulatory strategies with accompanying required data to accelerate asset development while enabling market differentiation Support strategic development of US/CA labelling documents for initial submission, line extensions, key MOH-initiated changes, and key PMR-related updates, and provide responses to agency labelling questions in collaboration with Regulatory Scientist. Apply labelling expertise, competitor knowledge, and regulatory precedent to propose labelling content to influence commercially viable labelling Confirm, challenge, influence, and communicate strategic discussions based on industry precedent and new developments Determine and communicate submission and approval requirements and regulator expectations Assist Regulatory Scientist to generate regulatory documents for submissions Propose innovative solutions to regulatory and labelling issues to meet the business objectives while maintaining compliance with applicable regulations and internal quality systems Provide high quality, timely and decisive regulatory advice, in collaboration with the Regulatory Scientist, that enables business partners to make well-informed decisions on development of drugs, diagnostics, devices, and product lifecycle planning and business development Communicate regulatory risks, potential impact and mitigation plans with development team leadership and regulatory management Execute high quality communications with FDA, Health Canada and internal customers to articulate and ensure understanding of the regulatory strategy in partnership with Regulatory Scientist Requirements:
Bachelor's degree in scientific or health sciences discipline Preferred industry-related experience in regulatory affairs and/or drug development experience for 2 years Knowledge of FDA and Health Canada procedures and practices across Review Divisions and awareness of evolving regulatory reform initiatives desirable Demonstrated deep knowledge of the drug development process, regulatory/business strategies and plans required Demonstrated ability to assess and manage risk in a highly regulated environment Demonstrated strong written, spoken and presentation communication Demonstrated negotiation and influence skills Demonstrated attention to detail Demonstrated effective teamwork skills; able to adapt to diverse interpersonal ss

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