Sponsor Dedicated Local Regulatory Associate - based in ROME

Syneos Health; Milano; In loco; EUR 31.500 - 38.500; Tempo pieno

Descrizione del lavoro

Syneos Health in Rome seeks a Local Regulatory Associate to provide regulatory expertise for a portfolio of products, working closely with the Sponsor’s local team and interfacing with national authorities. The role requires attendance at Sponsor offices in Rome and fluency in Italian.

The ideal candidate has 2–4 years in regulatory affairs, experience with local labeling, and strong communication in Italian and English. CCNL applicability and local procedures govern employment.

Competenze

• Experience across the drug development life-cycle (development and post-authorization).
• 2–4 years in regulatory affairs and understanding of local/regional requirements.
• Experience negotiating with Regulatory Authorities.
• Ability to interact with International Regulatory Affairs colleagues, other departments within the Company and external parties (national authorities, trade associations, professional bodies, etc.).
• Ability to assess complex scientific information, regulatory precedent, competitive intelligence, and regulatory guidelines and make recommendations based on assessment.
• Experience with Veeva RIM module.
• Strong problem-solving skills and ability to work in cross-functional teams.
• Ability to plan, prioritize, and execute work.
• Italian mother tongue; strong written and verbal communication in Italian and English.

Mansioni

• The Local Regulatory Associate will work dedicated to a single Sponsor. Attendance to the Sponsor's offices in Rome will be required.
• Provide local regulatory support, including local submissions and regulatory insight.
• Prepare local labeling documentation and review Advertising and Promotional Material.
• Interact with AIFA and with other company departments and external bodies as required.

Conoscenze

Regulatory affairs

Cross-functional teamwork

Communication skills

English proficiency

Italian

Strumenti

Veeva RIM

Descrizione del lavoro

Description

Sponsor Dedicated Local Regulatory Associate - based in ROME

Sponsor Dedicated Local Regulatory Associate - based in ROME

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

The Local Regulatory Associate will work dedicated to single Sponsor. Attendance to the Sponsor's offices in Rome will be required.

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.)
• Ability to assess and understand complex scientific information, regulatory precedent, competitive intelligence, and regulatory guidelines and make recommendations based on assessment
• 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.

The potential annual gross salary for this role will start at EUR 35,000.00

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.

Summary

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.