Regulatory Strategist

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

International – Reg Strategy Manager, Sr Manager (LATAM)

The Regulatory Affairs Manager will be lead and support submissions in Latin American Markets for MAAs and life-cycle management procedures and will provide local expertise as a member of the Global Regulatory Affairs (GRA) team to ensure Vertex establishes and implements best practices.

Key Duties & Responsibilities

• Drive and coordinate regulatory strategy and local regulatory activities in Latin America and provide regional regulatory expertise for geographical expansion.
• Track all Health Authorities’ requests and relevant new local regulations and forward to relevant GRA contact.
• Maintain current knowledge of local requirements and anticipate, assess and communicate changes to Regulatory Senior Management in a timely manner.
• Lead cross functional Vertex team to prepare submission activities from the planning phase through to submission and review, including preparing responses to questions.
• Act as support to submission lead by preparing timelines and creating submission binders in Veeva and ensuring submission and correspondence files are up to date
• Provide local regulatory expertise, maintain current knowledge of local requirements and anticipate, assess and communicate changes to local and RA Senior Management in a timely manner
• Act as local expert for regulatory queries coming from other functions, e.g. medical and supply chain, on topics such as regulatory requirements, local labelling guidance, CTD and GMPs.
• Ensure all work is compliant with regulatory requirements and company policies and procedures

Regulatory Experience & Education Requirements

• Relevant industry experience in regulatory affairs in Latin America and understanding of current trends in local and regional requirements.
• Recognized as a knowledgeable resource for regulatory advice by other departments
• Experience of interacting with Regulatory Authorities
• Must be able to facilitate interactions with International Regulatory Affairs, other departments within the Company and external parties (mainly submission partners)
• Bachelor’s degree in Pharmaceutical Sciences
• Advanced written and spoken English and knowledge of Spanish and Portuguese will be considered an advantage

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.