Regulatory Specialist - Germany

Syneos Health, Inc.

Job Overview

Location

DEU-Remote

Job Type

Full-time

Full Job Description

📋 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 and Medical Writing.
• Identifies and evaluates fundamental issues pertaining to Site Start-Up, project regulatory pathway, successful patient enrollment, interpret data on complex issues, make good business decisions, and ensure solutions are implemented.
• Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and 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.
• Updates plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes. Complies 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 back log.
• 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.

🎯 Requirements

• Bachelor's degree in a relevant field (e.g., life sciences, regulatory affairs, law).
• 5+ years of experience in regulatory affairs, preferably in the pharmaceutical or biotechnology industry.
• Strong knowledge of regulatory requirements and guidelines, including ICH, FDA, EMA, and other international regulations.
• Excellent communication, negotiation, and project management skills.
• Ability to work in a fast-paced environment and prioritize multiple tasks and projects.
• Strong analytical and problem-solving skills.
• Proficiency in Microsoft Office and other software applications.
• Ability to travel up to 20% of the time.

🏖️ Benefits

• Competitive salary and benefits package.
• Opportunities for career growth and professional development.
• Collaborative and dynamic work environment.
• Recognition and rewards for outstanding performance.

🏠 Location

• Remote - Germany only.
• Syneos Health, Inc. is an equal opportunity employer and welcomes applications from diverse candidates.
• We are committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Skills & Technologies

Remote

Degree Required

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Syneos Health, Inc.

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About Syneos Health, Inc.

Syneos Health is a global biopharmaceutical services organization providing clinical and commercial solutions. It integrates clinical development, outsourced commercialization, consulting, and communications services to accelerate the delivery of therapies to market. The company supports pharmaceutical, biotechnology, and medical device clients across all phases of product development and commercialization, operating in North America, Europe, and Asia-Pacific.

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