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Job Details

Senior Director, Regulatory Affairs

Company: Thornshaw Recruitment
Location:
Reference: TD9528
Closing Date: 25 Oct 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

The Senior Director, Regulatory Affairs will be responsible for leading the Regulatory Affairs functions for the company within Europe and specific additional regions. Based in Dublin or UK.

Requirements:

The Senior Director, Regulatory Affairs will be responsible for leading the Regulatory Affairs functions for the company within Europe and specific additional regions.   Based in Dublin or UK.

Essential Duties and Responsibilities:


• 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, labelling 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, labelling 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 labelling and supply within the European Union.


Job Requirements:
Education:
• Bachelor’s Degree in a scientific or healthcare discipline preferred (advanced degree or relevant certification a plus). 
Experience:
• 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.


For futher detail contact Tina at +353 1 2784671

Apply for this job: Senior Director, Regulatory Affairs

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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