Sponsor Dedicated Local Regulatory Associate - based in ROME

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7h2cxx

Sponsor Dedicated Local Regulatory Associate - based in ROME July 24, 2026 Sponsor Dedicated Local Regulatory Associate - based in ROME Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success.

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. technical and therapeutic area training; We are committed to building an inclusive culture – where you can authentically be yourself.

We are continuously building the company we all want to work for and our customers want to work with. 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.

The Local Regulatory

Associate will work dedicated to single Sponsor. The role involves supporting local submissions, providing local regulatory insight, preparing local labelling documentation and reviewing Advertising and Promotional Material. The successful applicant will work closely with the Sponsor's local team and will be expected to interact directly with AIFA as required as well as with other company departments and external bodies. Mother-tongue Italian speak is a must.

Desired Experience: Experience across the drug development life-cycle (development and post-authorization) Relevant industry experience in regulatory affairs (2 - 4 years)



and understanding of current trends in local and regional requirements.

Experience of managing negotiations with Regulatory Authorities Ability to successfully facilitate interactions with International Regulatory Affairs colleagues, other departments within the Company and external parties (national authorities, trade associations, professional bodies, etc.) Experience with Veeva RIM module Strong problem-solving skills and ability to work in cross-functional teams Ability to plan, prioritize, and execute work and projects in a systematic and efficient manner Italian mother tongue Strong written and verbal communication skills to explain difficult information and build alignment (both Italian and English) The employment relationship shall be governed by the National Collective Labour Agreement (CCNL) for employees of companies operating in the tertiary, distribution and services sectors ("CCNL Commercio"), and all related provisions shall apply, including Article 213, in its version in force from time to time. 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. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the .

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. This role will be responsible for providing local (Italian/EU) regulatory expertise to ensure the handling of a life-cycle portfolio of rare disease products in accordance with corporate procedures and national requirements. If your pastexperience doesn’t align perfectly, we encourage you to apply anyway.

We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most.

Syneos

Health® (Nasdaq: SYNH) is a leading integrated biopharmaceutical solutionsorganization built to accelerate customer success. We translate unique clinical,medical affairs and commercial insights into outcomes to address modern marketrealities. Together we share insights, use the latest technologies and applyadvanced business practices to speed our customers’ delivery of importanttherapies to patients.

Phone: (phone hidden) All qualified applicants will receiveconsideration for employment without regard to race, color, age, religion, marital status,ethnicity, national origin, sex, gender, gender identity, sexual orientation, protectedveteran status, disability or any other legally protected status and will not bediscriminated against. If you are an individual with a disability who requires reasonableaccommodation to complete any part of our application process, including the use of thiswebsite, please contact us at: Email: jobs@syneoshealth.

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7h2cxx