Our client is a Biopharma organization from the US with office based in Dublin in the last year. They are seeking a Senior Director of their Regulatory Affairs. The incumbent will be responsible for leading the Regulatory Affairs functions within Europe and specific additional regions. A scientific degree with a minimum of 5 years Regulatory experience (10 years Pharmaceutical experience) is required as a minimum. 20% travel associated with this role.
• Ensure appropriate support for program maintenance, post-marketing studies and development programs by direct ‘hands-on’ work or supervision and direction of in-house and contract staff.
• Provide direction to assigned programs by overseeing or coordinating all aspects of regulatory strategy, agency interactions, and submissions pertaining to these regions.
• Working with staff workflows to identify overlap and redundancies with within the US/FDA filings and ensure coordinated submissions.
• Provide regulatory guidance and support for existing and ongoing business development functions and partnership alliance management for specific geographical regions, including Europe.
• Provide input into assessments of emerging regulatory trends and precedents as to their potential impact to the business.
• Provide regulatory affairs project management including timelines and tracking of ongoing regulatory activities and supporting departmental budgeting activities.
• Review key documents (e.g., clinical study protocols, labeling etc) to ensure adherence to regulatory requirements and guidance’s and GCP quality standards.
• Manage submission activities (e.g., IND/CTA and amendments, NDA, MAA, DMF) and health authority interactions (meeting requests and briefing documents), ensuring adherence to regulatory and quality standards and project timelines.
• Provide oversight and management of external regulatory and development vendor resources.
• Serve as a key contact with EMA regulatory project manager.
• Provide oversight of company documents and document systems supporting development activities.
• Oversee Regulatory Affairs Department staff and contractors.
• Ensure adherence to Regulatory Affairs budget and achieving company regulatory goals according to agreed timelines and with a high level of quality.
• Support medical affairs and corporate activities, including review of publications and investor relations/legal public disclosures.
• Oversee regulatory aspects of commercial product packaging, labeling and supply for EU countries
• Support business development activities related to partnering and licensing opportunities and alliance management
• Management of regulatory affairs aspects of commercial product labeling and supply within the European Union.
• Bachelor’s Degree in a scientific or healthcare discipline preferred (advanced degree or relevant certification a plus).
• At least 5 years’ experience in pharmaceutical regulatory affairs or quality assurance or at least 10 years in pharmaceutical development (e.g., clinical, nonclinical safety) with significant experience in regulatory and/or quality focused activities.
• Broad knowledge of health authority regulations, guidelines, and quality “best practices” and the ability to interpret applicability to specific products.
• Excellent communication (verbal, written, and presentation) and interpersonal skills.
• Detail oriented with a sharp eye for content and quality.
• Excellent planning, organizational, and decision making capabilities.
• Must be able to balance multiple or changing priorities and resolve problems independently.
• Expertise in core computer software applications (especially MS Project) as well as technical requirements for electronic regulatory submissions (e.g., eCTD).
• Must be willing to travel (up to 20%) domestically or internationally as needed.
If you would like further Information you can contact the recruiter directly:
Karen Shiel | Tel: +353 (0) 1 5079256