Regulatory Associate - AdPromo

Syneos Health, Inc.; Mexico; Hybrid; PHP 1,104,000 - 1,914,000; Full time

Job summary

Syneos Health in a remote setup seeks a Regulatory Associate - AdPromo to support regulatory agency submissions, regulatory research, and product development under supervision. You will contribute to creating submission documents for INDs, NDAs/MAAs, DMFs, and related lifecycle activities across global programs.

This role offers exposure to a leading biopharma services organization and cross-functional collaboration to drive timely submissions.

Qualifications

• Experience supporting regulatory agency submissions and lifecycle maintenance.
• Familiarity with INDs, NDAs/MAAs, and DMFs.

Responsibilities

• Under supervision, supports regulatory agency submissions, regulatory research, and product development.
• Creation of submission documents to support INDs, NDAs/MAAs, DMFs, and related lifecycle activities.

Job description

Updated: Yesterday Location: Remote, MEX, Mexico Job ID:25108925-OTHLOC-7302-2DR

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.

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

• Build and institutionalize regulatory project management frameworks, tools, and best practices to enhance GRA-AP capability and effectiveness.
• Provide oversight of GRA-AP projects and portfolios, ensuring alignment with objectives and timelines.
• Coordinate and facilitate communication among regulatory affairs, project teams, stakeholders, and external partners to support project execution.
• Track project progress, materials, and deliverables, proactively identifying and resolving issues to maintain project momentum.
• Lead and participate in regulatory project meetings, including documenting minutes, updating project portals, and communicating outcomes to stakeholders.
• Perform administrative functions to support project teams and department operations.
• Assume additional duties as assigned to ensure regulatory project and portfolio success.

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

Under supervision, supports regulatory agency submissions, regulatory research, and productdevelopment. Responsibilities typically include the creation of submission documents to supportinvestigational new drug applications (INDs), new drug applications or new marketing applications(NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs)and other lifecycle maintenance activities.

Description

Regulatory Associate - AdPromo

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.

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

• Build and institutionalize regulatory project management frameworks, tools, and best practices to enhance GRA-AP capability and effectiveness.
• Provide oversight of GRA-AP projects and portfolios, ensuring alignment with objectives and timelines.
• Coordinate and facilitate communication among regulatory affairs, project teams, stakeholders, and external partners to support project execution.
• Track project progress, materials, and deliverables, proactively identifying and resolving issues to maintain project momentum.
• Lead and participate in regulatory project meetings, including documenting minutes, updating project portals, and communicating outcomes to stakeholders.
• Perform administrative functions to support project teams and department operations.
• Assume additional duties as assigned to ensure regulatory project and portfolio success.

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

Under supervision, supports regulatory agency submissions, regulatory research, and productdevelopment. Responsibilities typically include the creation of submission documents to supportinvestigational new drug applications (INDs), new drug applications or new marketing applications(NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs)and other lifecycle maintenance activities.

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.