Sr Regulatory Associate PM; US or LATAM

Sr Regulatory Associate PM (US or LATAM Based Only)

Updated:
Yesterday

Location:

USA-MA-Remote
Job :

Description

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.

We continuously simplify and streamline our work to make Syneos Health easier to work with and for. Whether you join us in a Functional Service Provider partnership or a Full‑Service environment, you’ll collaborate with passionate problem solvers to help our customers achieve their goals. We are agile, driven and passionate to accelerate therapy delivery and change lives.

WORK HERE MATTERS EVERYWHERE

Key highlights:

• Passionate people development and career progression with supportive line management.
• Commitment to Total Self culture that allows authentic being.
• Diversity and inclusive culture fostering belonging.

Job Responsibilities

Fully Remote in US and LATAM Only. Must be eligible to work in US or LATAM without Visa sponsorship.

• Under limited supervision, perform detailed and confidential project‑related duties directly related to regulatory submissions and compliance.
• Create and edit regulatory reports, summarize public domain data, conduct quality control reviews, and support 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.
• For non‑complex submissions, independently fulfill preparation and submission of full application or components of IND and other marketing applications to ensure compliance with regulations.
• Maintain regulatory databases, logs, and provide updates per client requirements.
• Conduct quality control reviews, track documents to final submission.
• Attend client meetings as needed and build client relationships.
• Identify risks to project delivery and propose issue resolution.
• Assist in training and mentoring of team members as required.
• Support content plan creation and maintenance within Veeva Vault RIM.

Qualifications

• 3‑5 years of regulatory experience within industry.
• BS/BA degree or equivalent practical experience.
• Excellent interpersonal and communication skills.
• Advanced Microsoft Office skills.
• Strong analytical skills and ability to work independently.
• Fluent in English (speaking, writing, reading).
• In‑depth understanding of FDA, EMA, ICH requirements; familiarity with eCTD, NDA, IND, EU CTA, MAA, EU CTR, NDS.
• Experience with Veeva Vault and project management tools preferred.

Benefits & Compensation

Salary range: $47,000–$79,900 USD. Benefits include health benefits, 401(k) match, employee stock purchase plan, commission/bonus potential, paid time off, and car allowance.

We are an Equal Opportunity Employer and comply with the Americans with Disabilities Act. All qualified applicants will receive consideration without regard to race, color, age, religion, gender, sexual orientation, disability, or other protected status.