Associate Director Clinical Trial Regulatory Affairs

Associate Director Clinical Trial Regulatory Affairs, Remote- or Hybrid based in Serbia.

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

We are seeking a regulatory delivery professional with demonstrated expertise in IVD and Companion Diagnostic (CDx) regulatory strategy and submissions under the In Vitro Diagnostic Regulation (IVDR). In addition to candidates possessing specific technical and functional expertise (e.g., Early Access Programs (EAP), IVDR/CDx submissions, and related regulatory disciplines), the ideal candidate will bring strong operational execution capabilities and a proven track record of delivering high-quality regulatory submissions.

Profile

A regulatory professional responsible for translating regulatory strategy into compliant, accurate, and timely execution, ensuring successful submission delivery while proactively managing risks, dependencies, and stakeholder alignment.

Key Responsibilities and Outcomes

• Ensure submission readiness through high-quality regulatory documentation and execution.
• Develop and maintain accurate regulatory plans, timelines, and assumptions.
• Coordinate the timely collection, review, and management of submission documentation.
• Identify regulatory risks, constraints, and potential challenges early in the process.
• Align regulatory activities with broader study activation and project plans.
• Maintain compliance with applicable local, regional, and global regulatory requirements.

Required Competencies

• Regulatory submission planning and execution
• In-depth knowledge of country-specific and regional regulatory requirements
• Strong project planning, coordination, and document management skills
• Commitment to quality, compliance, and operational excellence
• Proactive risk identification and mitigation
• Effective cross-functional communication and stakeholder management
• High attention to detail with a focus on data integrity and milestone accuracy

Required Experience

• Experience preparing, coordinating, or overseeing clinical trial regulatory submissions
• Proven ability to manage submissions across multiple countries and regulatory pathways
• Management of complex submission documentation, timelines, and interdependencies
• Collaboration with study teams, investigative sites, regulatory authorities, and other key stakeholders
• Resolution of submission readiness, quality, and compliance issues within regulatory programs

Additional Requirements

• Expertise in IVD/CDx regulatory strategy and submissions under IVDR is essential.
• Fluency in English, both written and verbal, is required.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is 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.