Associate Director, Regulatory Advice and Delivery

* JOB SUMMARY *

Assists and directs the customer-focused leadership and management of Regulatory Advice and Delivery Site Start-Up (RAD SSU) deliverables within the assigned projects or programs. Directs the technical and operational aspects of the RAD deliverables of the assigned projects. Accountable for the delivery of the post award early regulatory guidance and the regulatory impact assessment during study maintenance on time, on budget, and in compliance with all applicable regulations. Responsible for performing and overseeing core regulatory activities (such as core compilation and review of documents, and core submissions) related to submission from Site Start-Up activities until study end. Develops integrated RAD timelines and reports weekly progress including plans to address potential risks/gaps to the project team, Project Manager (PM), SSU Management and Project Sponsor. May act as the Regulatory Subject Matter Expert (SME) or as a mentor for less experienced staff. Assists senior RAD management for the SSU regulatory intelligence maintenance such as medical device and/or GMO regulation data mining in local country regulation, regulatory trainings support to the business departments.

* JOB RESPONSIBLITIES *

* Effectively manage the RAD resources including oversight of all project RAD deliverables which encompasses all activities from early post award regulatory guidance to study end

* Develops new business opportunities whenever possible (e.g., while in attendance at professional conferences/seminars), participates in new business development activities including participation at client presentations. Reviews proposals, attends client sales-focused meetings, and provides information to support business development activities. Maintains strategic relationships with customers in alignment with their assigned projects such as processes and solutions and proactively assess client needs.

* Reviews the project RAD budget with the functional leads, project PM, and the SSU Business Unit Controller against SOW, project milestones and budget to ensure project profitability. Eventually takes corrective measures where necessary to keep project activities in line with budget and gross profit expectations.

* Accountable in parallel to lead and provide adapted oversight regulatory activities for projects having high complex regulatory profile as Operational Regulatory Subject Matter Expert with major functional area leads (Project Management, and Clinical Management)

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* Deliver overall RAD strategy driven by an operational risk management approach and status at client meetings and communicates outcomes to project team. Ensures all project deliverables meet the internal and customers' expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessment.

* Develops and manages integrated RAD timelines and reports weekly progress including plans (to address potential timing risks/gaps or project regulatory KPI's) that track project's regulatory quality, delivery and predictability

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* Monitor and ensure team's accountability, efficiency and adherence to project timelines. Ensure quality of designated deliverables. Responsible for driving team efficiencies with a goal of reducing waste and increasing RAD predictability. Accountable for individual utilization metrics.

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* Oversee development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching. Identify skills and abilities that allow a regulatory professional to represent the function effectively as a member of a multi-disciplinary team. Support team with proposal development and client pitches (where applicable).

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* Approves courses of action for staff members on salary administration, interviewing and selection, terminations, professional development, performance appraisals, position description preparation, and employee counseling

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* Pro-actively supports RAD intelligence strategies and communications

* Identify and interpret laws, regulations, and guidance documents for domestic and international agencies relevant to the development and commercialisation of healthcare products. Identify new regulatory trends that could affect future requirements
* Evaluate the global healthcare environment and its potential impact on the organisation.
* Develop Regulatory Intelligence Programs on specific regulatory complex topics. Monitor team adherence for the timely follow-up for SSU operational Regulatory Intelligence Maintenance. Maintain current knowledge of applicable regulations and guidelines and direct implementation of training, as necessary.
* Develop negotiation strategies with regulatory agencies and/or the regulated industry
* Develop leadership skills and presentations that inspire high performance within the regulatory environment.at team or departmental review meetings. Have oversight of training programs for appropriate Syneos departmental teams. Designs presentations and delivers information in a way that allows the audience to understand the information and interact appropriately. and explain the importance of adapting to the changing regulatory environment

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* Designated as subject matter expert in specific regulatory areas (e.g. pediatric studies, advanced therapy products, medical devices, etc.) to author and review Standard Operating Procedures (SOPs) and Work Instructions (WI) to support new or existing processes

* Ensure personal compliance and/or accuracy with relevant quality standards. Consistently achieve and maintain utilization target and departmental goals
* Maintains current knowledge of applicable regulations and guidelines. Identify relevant laws, regulations, and guidance documents covering pre and/or post-market requirements for healthcare products
* Explain the role of RAD professionals, their interrelationships with other functions in the organization and the importance of working as a team and operate effectively as a member of a multi-disciplinary team
* Prioritise work to meet timelines and use a systematic approach to accomplish assigned tasks.

*Other Responsibilities:*

* Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management.
* Ability to travel as required - approximatelly 40%

* Minimum of a BA or BS

* Minimum of seven (7) years' experience working in a Clinical Research environment with a minimum of five (5) years regulatory experience or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities do the job. Minimum of two (2) years of management experience

* Subject matter expertise in current regulation frameworks (e.g. regulations and guidelines specific for non- interventional studies, clinical trial and medical device regulations) with extensive clinical trial experience

* Experience in working to applicable GxPs (e.g GVP, GCP, ISO 14155) etc

* Strong CRO operational experience with a track record in project management working in an international or global capacity.

* Thorough knowledge of applicable regulations, drug development, and clinical project management procedures.

* Previous experience in budgeting and quality management

* Excellence communication and interpersonal skills, both written and spoken, with an ability to influence, convince and persuade

* Strong leadership skills; ability to teach/mentor team members

* Ability to recognize and take appropriate action when employee performance is not acceptable

* Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, email, and Internet.

* Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.