Director - Clinical Regulatory Operations

UBC are a leading provider of pharmaceutical support services, partnering with life science companies to demonstrate value, ensure safe use and accelerate patient access to innovative medical products. Our services range from supporting the largest brands in the industry, to providing fully outsourced functional services, to the most recently approved genetic therapies in orphan populations. The work we do positively impacts patients’ lives all over the world.

Reports To:

Executive Director, European Late Stage Operations 

Brief Description:  

Provide leadership and responsible for the overall planning, direction, and implementation of global regulatory activities. Leads the EU regulatory operations team, formulates global regulatory intelligence, the maintains regulatory documents and processes, and develops the regulatory strategy to achieve regulatory approvals and clearances worldwide expediently and consistently for all studies and programs. 

Supervisory Responsibilities:

Mentor, provide support, and oversee EU Regulatory Operations Associates and EU Regulatory Operations Managers 

Requirements:

• Bachelor of science degree in an appropriate discipline or equivalent industry experience; advanced degree preferred
• Minimum 12 – 15 years of clinical research operations experience, within in a CRO, pharmaceutical, device/diagnostics or biotechnology company
• Minimum 8 years of operational regulatory affairs experience pertinent to clinical trials non-interventional/observational studies 
• Minimum 5 years supervisory/management experience
• Deep understanding and experience in operational regulatory affairs, clinical operations, and overall drug/biologic development processes
• Working knowledge of functional components of clinical drug development (e.g., clinical, data management, statistics and medical writing)
• Strong knowledge of ICH GCP, EU Clinical Trials Directives, FDA Guidelines, and applicable international regulations 
• Broad therapeutic experience a plus
• Strong verbal and written communication and interpersonal skills
• Strong prioritization, time management, and project management skills
• Strong negotiation, influencing, consensus building, and relationship management skills
• Strong innovative, analytical, problem-solving and decision-making skills
• Strong computer skills including MS Office
• 10% travel availability
• Results driven and team-oriented, with the ability to influence outcomes as necessary
• Demonstrated ability to manage a staff to achieve company and client goals
• Ability to handle multiple tasks in a fast-paced environment
• Strong interpersonal skills in a fast-paced, deadline oriented environment 

Specific Job Duties:

• Responsible for the overall planning, direction, and implementation of global regulatory activities
• Lead, innovate, and develop operational regulatory strategies that are reflective of applicable international requirements, ensure submissions meet requirements, and maximize regulatory success
• Serve as the global technical expert on relevant regulatory issues potentially impacting UBC projects and activities 
• Be familiar with and comply with SOPs, ICH GCP, EU Clinical Trials Directives, FDA Guidance, and applicable international regulations
• Ensure the provision of current and robust regulatory information to support clinical project teams, functional departments, and sponsors 
• Provide global regulatory expertise to clinical project teams and functional departments (e.g., EU clinical trial directive, country specific requirements, submission and approval timelines, IP labeling, import / export)
• Liaise with UBC compliance and legal and provide global compliance guidance to clinical project teams and functional departments (e.g., GDPR, other data privacy regulations) 
• Responsible for the supervision, training, and mentoring of the EU regulatory operations team 
• Responsible for the development, implementation, and process compliance of the regulatory strategy for projects by the EU Regulatory Operations team
• Manage departure structure and strategies based on current staffing and project needs; work with Project Directors and Project Managers to ensure projects are adequately staffed
• Lead the regulatory staff working on projects to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality 
• Review project progress through scheduled meetings with regulatory team 
• Ensure regulatory activities on projects are conducted according to current regulations and to UBC and client SOPs
• Ensure staff are adequately trained on applicable SOPs, processes, and systems (e.g., CTMS)
• Ensure conduct of project related training and record keeping for EU regulatory operations team
• Ensure adherence to Regulatory Submission Plans, UBC policies and / or sponsor SOPs
• Assess training requirements of the direct reports, and develop / deliver training materials as necessary
• Proactively identify potential improvements to processes, quality and overall regulatory delivery
• Identify and develop UBC process improvements 
• Prepare procedures, SOPs, guidelines and other standard materials for departmental function
• Conduct interviews for internal/external regulatory resource candidates
• Conduct ongoing performance review of assigned staff and remediate deficiencies
• Conduct annual performance reviews
•  Serve as the UBC senior regulatory contact with sponsors as required
• Serve as the main regulatory lead and contact with Sponsor and internal UBC teams for select projects 
• Provide regulatory written content and review of study protocols, investigator's brochures, IP labels, other clinical documents, UBC communications, and other documents as requested
• Participate in client meetings, calls and project specific activities as appropriate to ensure regulatory staff are meeting project needs in a systematic manner 
• Maintain up-to-date knowledge of regulatory requirements and maintain regulatory intelligence database
• Daily monitoring of changes in the regulatory environment, both general and specific to clinical operations; and train, advise, and support project teams and department staff accordingly 
• Provide advice to UBC regulatory, clinical operations, and other departments on interpretation of new legislation, guidance, and directives; work closely with UBC Legal when necessary
• Develop and manage professional relationships with competent authorities  
• Ensure regulatory activities on projects are managed per scope and within the contracted budgets
• Work with Project Directors and Project Managers to identify out-of-scope activities and change orders
• Ongoing review of financial profitability and forecasting across projects for the EU regulatory department 
• Create high quality reports and other outputs according to the defined specifications to ensure timely reporting of team metrics to senior management.
• Contribute, as directed, on specific Business Development opportunities: capabilities presentations, RFP review, budget development, bid defense preparation and delivery
• Attend and present at conferences as required
• Provide monthly departmental update to Executive Director
• Other duties as assigned by Executive Director, Clinical Operations, Europe

UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.

#LI-AP1

#LI-Remote