[Hiring] Regulatory Specialist @Syneos Health

Role Description

Collaborates with major functional areas including, but not limited to:

• Business Development
• Alliance Management
• Contracts and Proposals Development
• SSU Country Managers
• Project Management
• Clinical
• Data Management
• Medical Writing

Identifies and evaluates fundamental issues pertaining to:

• Site Start-Up
• Project regulatory pathway
• Successful patient enrollment
• Interpreting data on complex issues
• Making good business decisions
• Ensuring solutions are implemented

Ensures all project deliverables meet:

• Internal and customers’ expectations as per contracted deliverables
• Providing accurate projections, reports, and updates
• Ongoing risk identification, mitigation, and management

Develops and maintains relationships with customers in alignment with their assigned projects.

Ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed.

Provides oversight of all project start-up deliverables which encompasses all activities for the life cycle maintenance of projects.

Assumes accountability on start-up deliverables including, but not limited to:

• Life Cycle maintenance regulatory activities (study maintenance and amendment submissions, oversight of communication to competent authorities/ethics committees, import/export license extensions)
• Oversight of delivery of executed amended clinical trial agreements and investigator budgets with investigator sites
• Overall SSU timelines following site activation, including any realignment required due to amendment needs

Updates plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes. Complies with all controlled document requirements and other requirements to ensure quality deliverables.

Develops and manages integrated timelines and reports weekly progress including plans to address potential timing risks/gaps.

Prepares/assists and presents overall SSU strategy and status at client meetings and communicates outcomes to project team.

Reviews the project SSU budget with the functional leads, PM, and the SSU Business Unit Controller against project milestones and budget to ensure project profitability. Takes corrective measures where necessary to keep projects in line with budget and gross profit expectations.

Uses professionally recognized tools for planning and management of scope, timeline, and resources and ensures effective budget management. If out-of-scope work is requested, notifies the PM and SSU Manager and tracks out-of-scope work until it is assigned to backlog.

Prepares the core submission documents and core clinical trial application dossier for amendments during life cycle maintenance of the projects.

Performs a Regulatory Impact Assessment on core amendment submission documents and communicates any risk mitigation to Sponsor/Project teams and oversees review for Regulatory Impact Assessment for 2nd level to identify gaps, highlights any risk management to Sponsor/Project teams.

Assists in amendment updated development of master Subject Information Sheet (SIS) /Informed Consent Form (ICF) in collaboration with the PM and Medical Department.

Oversees collation, quality review, and submission of country-specific applications.

Contributes to change initiatives across and within the SSU department.

Qualifications

• Experience in regulatory affairs or related field
• Strong communication and interpersonal skills
• Ability to work collaboratively across multiple teams
• Detail-oriented with strong analytical skills

Requirements

• Proven experience in project management
• Knowledge of regulatory requirements and processes
• Ability to manage multiple projects simultaneously
• Proficiency in relevant software and tools

Benefits

• Career development and progression opportunities
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Inclusive culture