Sr Regulatory Associate PM – Remote (US or LATAM)
Job Summary:
Syneos Health is seeking a Senior Regulatory Associate – Project Management (PM) to join its global regulatory team. This fully remote role supports regulatory submissions, lifecycle maintenance, and compliance activities across the US and LATAM regions. Ideal for professionals with 3–5 years of regulatory affairs experience and strong command over global submission processes (INDs, NDAs, MAAs, DMFs). Work in a dynamic, fast-paced environment at the forefront of global drug development.
Salary Range: $47,000 – $79,900 per year
Work Mode: Remote (U.S. or LATAM-based only)
Key Responsibilities:
Manage and prepare non-complex global regulatory submissions (IND, NDA, CTA, MAA, DMF)
Conduct document QC and coordinate submission review and approvals
Update and maintain regulatory records and submission logs per SOP
Collaborate with project teams and attend client meetings
Perform risk analysis and escalate project risks when needed
Translate project timelines from Smartsheet to MS Project and Veeva Vault RIM
Assist with training and mentoring junior team members
Create and maintain content plans within Veeva Vault RIM
Ensure compliance with FDA, EMA, ICH, and regional regulations
Support lifecycle activities: variations, renewals, marketing authorization transfers
Required Skills & Qualifications:
Bachelor’s degree (BS/BA) in life sciences or equivalent experience
3–5 years of regulatory experience within the pharmaceutical or biotech industry
Strong understanding of global regulatory requirements (FDA, EMA, ICH, etc.)
Hands-on experience with Veeva Vault RIM, eCTD, IND, NDA, CTA, MAA, EU CTR
Advanced MS Office skills (Word, Excel, Project)
Excellent organizational, analytical, and communication skills
Ability to work independently and manage multiple concurrent projects
Fluent English (written and verbal)
Perks & Benefits:
Competitive base salary: $47,000–$79,900 annually
Flexible Paid Time Off (PTO) and sick leave
Health benefits: Medical, Dental, Vision
401(k) with company match
Employee Stock Purchase Plan (ESPP)
Bonus/commission eligibility based on performance
Company car or allowance (role-dependent)
Inclusion in Syneos Health’s global talent network and Total Self culture
About Syneos Health:
Syneos Health® is a fully integrated biopharmaceutical solutions organization that partners with pharma and biotech companies to drive clinical and commercial success. With 29,000+ employees across 110 countries, Syneos has contributed to 94% of all Novel FDA Drug Approvals in the last 5 years.
Work Mode: Remote (Only for candidates in the U.S. or LATAM)
Visa Sponsorship: Not available for this role
Ready to Advance Your Regulatory Career?
If you're passionate about regulatory compliance, submissions, and want to contribute to breakthrough therapies globally, apply now to join Syneos Health’s remote regulatory team.
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Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Frank Scottile Blvd |Missouri :
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Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
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Lake Charles | Shreveport |Nevada :
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Bavaria |Bavaria :
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Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | North York | Richmond Hill | Renfrew | Mississauga | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Tel Aviv | Yavne | Netanya | Kfar Saba | Be'Er Sheva |Remote :
Springville | Belgium | Xzagreb | Slovakia | Bountiful | Regulatory Labeling Manager (NA and LATAM Only) | Bishop | Castlebar | Lenexa | Leinster | Nairobi | Riga | McFarland | Remote - Europe | Lousiana | Ireland | Green Way | Texas | Faridabad | Blue Bell | Remote, USA | Switzerland | Manipal | Medan | Tulsa | French | Victoria | Zaragoza | Remote - South America (Latin Americal) | Minnesota | Hungary | Remote - Africa | Melbourne | Remote - Middle East | Thailand | Remote | Hammond |Republic of Colombia :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Rabigh | Jeddah | Najran | King Abdullah Economic City | Riyadh | Khulais |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
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Sweden |Taipei :
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