Associate Director, Regulatory Affairs

The Associate Director of Regulatory Affairs will lead teams by providing regulatory strategy and support for all International (inc. North America) regulatory submissions. The role will lead and support teams for all regulatory submissions and activities in relation to Clinical Trials and drug development.  The position will lead and support teams and efforts around filing activities, Health Authority interaction, attend meetings, and provide regulatory support to other departments, project teams, and committees. The role will also have direct reports and will support the development of the Regulatory department as well as support and enhance corporate Regulatory functions and facilitate business development and proposals in this area.  Candidates can be based in Spain, UK, Hungary, Poland, Romania, Slovakia or Serbia.

Essential functions of the job include but are not limited to:

• Provide regulatory guidance throughout the clinical development and drug development life cycle
• Lead, oversee and coordinate, review and provide strategic input on applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications
• Develop and/or review documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards
• Upon request/ need, represent Global Regulatory Affairs at project team meetings with both external and internal customers and manage/oversee regulatory workflow between departments
• Provide oversight to filing and study teams regarding regulations/guidelines and company SOPs to ensure successful and high-quality regulatory applications
• Ensure budgets and plans meet corporate requirements
• Provide ICH/GCP/Regulation guidance, advice and training to internal and external clients
• Participate in developing, implementing, and maintaining the corporate quality initiatives across business units within Clinical Solutions/Precision for Medicine.
• Mentor, train, and supervise staff at a functional level and supervise contract employees, as applicable
• Gather regulatory intelligence to keep abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval. Interprets emerging guidance and collaborates in impact assessment and implementation.
• Represent Regulatory function for BD activities including proposal development and review as well as bid defence strategy
• Assume responsibilities or initiatives in support of the function/company upon request of Regulatory Leadership
• May act as Regulatory Lead for certain assigned projects

 Job Qualifications: 

• 8+ years or more relevant regulatory affairs experience working for a Clinical Research Organisation, Pharmaceutical or Biotech company.
• Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones
• Specialized Knowledge of the Clinical Trial Information System (CTIS) under the Clinical Trial Regulation (CTR)
• Experience of regulatory activities including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, ODDs and PIPs.
• Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy
• Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied
• Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development in the EU and NA regions (mandatory) as well as other global regions (advantage)
• Able to understand and communicate regulatory requirements for pharmaceutical development submissions during the life cycle of a product.
• Ability to guide, train, and supervise personnel; oversees the work of direct reports to ensure on-time, on-target and within-budget results
• Availability for domestic and international travel including overnight stays
• Post Graduate Degree, Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
• Computer literacy (MS Office/ Office 365)
• Fluent in English

Competencies: 

• Foster a culture of mutual respect and collaboration
• Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency
• High level of integrity and must inspire exemplary behaviour of high ethics, transparency and demand highest professional standards  
• Makes decisions ba