Sr Regulatory Associate PM; US or LATAM

Sr Regulatory Associate PM (US or LATAM Based Only)

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.

This fully remote role in the US and LATAM is for professionals eligible to work in the US or LATAM without visa sponsorship.

• Perform detailed and confidential project-related duties directly related to regulatory submissions and regulatory compliance under limited supervision.
• Create and edit regulatory reports, summarize data in the public domain, conduct quality control review of documents, and collect and analyze data to produce reports supporting investigational new drug applications (INDs), new drug applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorization transfers (MATs), and other lifecycle maintenance activities.
• Prepare and submit full application or components of IND, marketing, and lifecycle maintenance applications to ensure compliance with government acts and regulations.
• Undertake information processing activities with high reliability and quality within tight timelines according to standard processes and operating procedures.
• Attend client meetings as needed and build client relationships in support of projects and deliverables.
• Coordinate project activity with project managers and directors, and identify and report risks to project delivery.
• Assist in training and mentoring of team members as required.

• 3–5 years of regulatory experience within the industry.
• BS/BA degree or equivalent practical experience.
• Excellent interpersonal and communication skills.
• Advanced Microsoft Office skills and strong analytical skills.
• Ability to work independently and understand detailed instructions.
• Fluent in speaking, writing, and reading English.
• In-depth understanding of regulatory requirements and guidelines including FDA regulations, EMA guidelines, and ICH standards (e.g., eCTD, NDA, IND, EU CTA, MAA, EU CTR, NDS).

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender identity, sexual orientation, protected veteran status, disability, or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, please contact us at

The annual base salary for this position ranges from $47,000 to $79,900 USD.