[Hiring] Regulatory Strategist @Syneos Health

Role Description

The Regulatory Affairs Manager will 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 establishes and implements best practices.

• 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 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 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.

Qualifications

• 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.

Benefits

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

Company Description

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.

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.