Sponsor Dedicated Site Start-Up & Regulatory Mgr - Remote Working (UK)

Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.

Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job responsibilities

• Understand the regulatory framework, including regional trends, for various types of applications and procedures supporting the global development of gene therapy advanced medicines.
• Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of submissions during clinical development from either a global and/or regional perspective.
• Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders; track progress and highlight unforeseen changes in resource demand
• Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission/document tracking, and document management
• Provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s)
• Review of documents and application forms (e.g. response documents, study protocols, PSRs, etc.).
• Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
• Use and share best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.
• Identify regulatory risks and propose mitigations to Regulatory team

What we're looking for:

• Relevant University Degree in Science or related discipline
• Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience
• General knowledge of drug development
• Strong project management skills and experience managing regulatory deliverables at the project level
• Leadership skills, including experience leading multi-disciplinary project team
• Excellent written and verbal communication skills
• Proficiency with common project management (e.g., MS Project) and document management tools
• Cultural awareness
• Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
• Ability to work independently and as part of a team
• Influencing and stakeholder management skills
• Ability to analyze problems and recommend actions
• Continuous Improvement and knowledge sharing focuses

Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

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.

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