Syneos Health, Inc.
Sr Regulatory Associate PM (US or LATAM Based Only)
Syneos Health, Inc., Frankfort, Kentucky, United States
Sr Regulatory Associate PM (US or LATAM Based Only)
Updated:
Yesterday Location:
USA-KY-Remote Job ID:
25100633 Syneos Health® is a leading fully integrated biopharmaceutical solutions organization. We accelerate customer success by translating unique clinical, medical affairs and commercial insights into outcomes. Why Syneos Health
Passionate people develop talent through career progression, technical and therapeutic training, peer recognition and total rewards. We foster a Total Self culture where you can authentically be yourself. Diversity of thought, background and perspective creates a place where everyone belongs. Job Responsibilities
Fully Remote in US and LATAM Only. Eligible to work in the US or LATAM without visa sponsorship. Under limited supervision, perform detailed project duties related to regulatory submissions and compliance. Create and edit regulatory reports, summarize public domain data, conduct quality control reviews, and analyze data to support INDs, NDAs/MAAs, DMFs, variations, renewals, MATs and other lifecycle maintenance activities. Prepare and submit full applications or components of IND, marketing and lifecycle maintenance applications. Maintain records, logs and regulatory databases as required. Conduct quality control reviews and track documents until final submission. Attend client meetings, build client relationships and coordinate project delivery and escalation. Assist in training and mentoring team members. Use Veeva Vault RIM for content plans and translate Smartsheet timelines into Microsoft Project and Veeva Vault RIM. Qualifications – External
3‑5 years of regulatory experience within industry. BS/BA degree or equivalent practical experience. Excellent interpersonal and communication skills. Advanced Microsoft Office skill. Strong analytical skill. Ability to work independently and understand detailed instructions. Fluent in English (speaking, writing, reading). In‑depth understanding of FDA regulations, EMA guidelines and ICH standards (eCTD, NDA, IND, EU CTA, MAA, EU CTR, NDS). Salary Range
The base salary range for this position is $47,000 – $79,900 USD. Actual salary will vary based on qualifications and experience. Contact
Phone: 919 876 9300 Fax: 919 876 9360 Toll‑Free: 866 462 7373 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. If you require reasonable accommodation to complete any part of the application process, please contact jobs@syneoshealth.com.
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Updated:
Yesterday Location:
USA-KY-Remote Job ID:
25100633 Syneos Health® is a leading fully integrated biopharmaceutical solutions organization. We accelerate customer success by translating unique clinical, medical affairs and commercial insights into outcomes. Why Syneos Health
Passionate people develop talent through career progression, technical and therapeutic training, peer recognition and total rewards. We foster a Total Self culture where you can authentically be yourself. Diversity of thought, background and perspective creates a place where everyone belongs. Job Responsibilities
Fully Remote in US and LATAM Only. Eligible to work in the US or LATAM without visa sponsorship. Under limited supervision, perform detailed project duties related to regulatory submissions and compliance. Create and edit regulatory reports, summarize public domain data, conduct quality control reviews, and analyze data to support INDs, NDAs/MAAs, DMFs, variations, renewals, MATs and other lifecycle maintenance activities. Prepare and submit full applications or components of IND, marketing and lifecycle maintenance applications. Maintain records, logs and regulatory databases as required. Conduct quality control reviews and track documents until final submission. Attend client meetings, build client relationships and coordinate project delivery and escalation. Assist in training and mentoring team members. Use Veeva Vault RIM for content plans and translate Smartsheet timelines into Microsoft Project and Veeva Vault RIM. Qualifications – External
3‑5 years of regulatory experience within industry. BS/BA degree or equivalent practical experience. Excellent interpersonal and communication skills. Advanced Microsoft Office skill. Strong analytical skill. Ability to work independently and understand detailed instructions. Fluent in English (speaking, writing, reading). In‑depth understanding of FDA regulations, EMA guidelines and ICH standards (eCTD, NDA, IND, EU CTA, MAA, EU CTR, NDS). Salary Range
The base salary range for this position is $47,000 – $79,900 USD. Actual salary will vary based on qualifications and experience. Contact
Phone: 919 876 9300 Fax: 919 876 9360 Toll‑Free: 866 462 7373 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. If you require reasonable accommodation to complete any part of the application process, please contact jobs@syneoshealth.com.
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