Sr Regulatory Associate PM; US or LATAM

Senior Regulatory Associate PM (US or LATAM Based Only)

Updated: Yesterday
Location: USA-NM-Remote
Job :

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.

Our Clinical Development model brings the customer and the patient to the center of everything we do.

We are continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for.

• Under limited supervision, perform detailed and confidential project‑related duties directly related to regulatory submissions and regulatory compliance.
• Perform limited general project administrative duties.
• Create and edit regulatory reports, summarize public domain data and conduct quality control review of documents.
• Collect and analyze data to produce reports to support INDs, NDAs/MAAs, DMFs, variations, renewals, MATs and other lifecycle maintenance activities.
• Prepare and submit full application or components of IND, marketing and lifecycle maintenance applications.
• Undertake information processing activities with high reliability at high quality and in tight timelines.
• Prepare records and/or logs and maintain or update regulatory databases.
• Conduct quality control reviews of documents and track until final submission.
• Attend client meetings and build client relationships.
• Review and coordinate work of Regulatory Associates and other Senior Associates.
• Identify risks to project delivery and propose issue resolution.
• Assist in training and mentoring of team members.
• Create and maintain content plans within Veeva Vault RIM.
• Translate Smartsheet timelines into Microsoft Project and Veeva Vault RIM.
• Assist with planning, managing, and tracking of regulatory submissions.

• 3–5 years of regulatory experience within industry.
• BS/BA degree or equivalent practical experience.
• Experience in a work‑related area preferred.
• Excellent interpersonal and communication skills.
• Advanced skills in Microsoft Office Applications.
• Strong analytical skills.
• Ability to work independently and understand detailed instructions.
• Ability to interact with staff from multiple departments.
• Ability to work concurrently on projects with specific instructions that may differ from project to project.
• Fluent in speaking, writing, and reading English.
• In-depth understanding of regulatory requirements and guidelines including FDA regulations, EMA guidelines and ICH standards.

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.

Company car or car allowance, health benefits (medical, dental, vision), company match 401k, employee stock purchase plan, commissions/bonus based on performance and flexible paid time off.

Annual base salary range: $47,000–$79,900 USD.

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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: