Regulatory Publishing Senior Consultant (LATAM)

Syneos Health, Inc.; São Paulo; A distancia; BRL 467.000 - 675.000; Jornada completa

Descripción de la vacante

Syneos Health is seeking a Regulatory Publishing Senior Consultant (LATAM) for a remote role based in Brazil. You will lead publishing activities from a portfolio perspective, ensuring timely delivery to global health authorities and adherence to regulatory standards.

The role requires experience in assembling submissions, coordinating with cross-functional teams, and driving process improvements for quality-driven submissions.

Formación

• Experience with regulatory publishing for LATAM and global health authorities.
• Ability to assemble and publish electronic submissions per regulatory guidance.
• Strong attention to detail to ensure accuracy and compliance.

Responsabilidades

• Publish electronic submissions for regulatory packages.
• Assemble all components of defined submissions per health authority guidance.
• Validate submissions based on experience and regulatory requirements.
• Manage portfolio views of upcoming submissions and interdependencies.
• Collaborate with submission managers and regulatory leads on timelines.
• Coordinate with source areas to ensure documents are compliant and ready for submission.

Conocimientos

Regulatory publishing

Submission management

Documentation review

Herramientas

Regulatory systems

eCTD publishing

Descripción del empleo

Regulatory Publishing Senior Consultant (LATAM)

Updated: Yesterday
Location: Remote, SP, Brazil
Job ID:25112549

Description

Regulatory Publishing Senior Consultant (LATAM)

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:

• 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.

The Regulatory Publishing Consultant is responsible for the creation, assembly, and publishing of electronic submissions and the delivery to global health authorities in an efficient and timely manner. The role is accountable for leading publishing activities on a portfolio level and responsible for the maintenance and lifecycle management submissions that are inter-related and dependent on multiple concurrent submissions. Can lead complex submission work across programs. This role will work with stakeholders and project teams for the timely delivery of content to be published, as well as drive for project teams the standards and expectations of format. This role is responsible for the accuracy of published output to client and industry standards and health authority requirements. The Regulatory Publishing Consultant will be responsible for leading process improvements for the accurate and quality driven execution of submissions

Key Duties and Responsibilities:

• Works independently within the publishing/content systems to create published output for submission
• Creates and assembles all components of defined submissions in required format as per health authority guidance
• Validates submissions through the application of acquired experience
• Manage portfolio views of upcoming submissions and publishing interdependencies
• Collaborates with submission managers and regulatory leads for submission preparation and timelines
• Liaises with functional source areas to ensure documents are compliant and submission ready
• Collaborates with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications

Job Responsibilities

The Regulatory Publishing Consultant is responsible for the creation, assembly, and publishing of electronic submissions and the delivery to global health authorities in an efficient and timely manner. The role is accountable for leading publishing activities on a portfolio level and responsible for the maintenance and lifecycle management submissions that are inter-related and dependent on multiple concurrent submissions. Can lead complex submission work across programs. This role will work with stakeholders and project teams for the timely delivery of content to be published, as well as drive for project teams the standards and expectations of format. This role is responsible for the accuracy of published output to Vertex and industry standards and health authority requirements. The Regulatory Publishing Senior Manager will be responsible for leading process improvements for the accurate and quality driven execution of submissions

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

The Regulatory Publishing Consultant is responsible for the creation, assembly, and publishing of electronic submissions and the delivery to global health authorities in an efficient and timely manner. The role is accountable for leading publishing activities on a portfolio level and responsible for the maintenance and lifecycle management submissions that are inter-related and dependent on multiple concurrent submissions. Can lead complex submission work across programs. This role will work with stakeholders and project teams for the timely delivery of content to be published, as well as drive for project teams the standards and expectations of format. This role is responsible for the accuracy of published output to Vertex and industry standards and health authority requirements. The Regulatory Publishing Senior Manager will be responsible for leading process improvements for the accurate and quality driven execution of submissions

Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday work improvespatients’ lives around the world. Selecting us as an employer secures a career inwhich you’re guaranteed to:

Syneos Health ® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.