Job Title: Senior Associate, Global Submission Management – Americas
Job ID: R-206638
Location: India – Hyderabad
Work Location Type: On Site
Date Posted: April 7, 2025
Category: Safety
About the Role
The Senior Associate, Global Submission Management – Americas will be responsible for managing the creation and delivery of regulatory submissions for Clinical Trial and Marketing Applications. This position plays a key role in ensuring technical compliance and operational excellence by collaborating with cross-functional teams and external partners for successful regulatory filings across the Americas region (US, Canada, South America).
Key Responsibilities
Lead/support Clinical Trial and Marketing Application submissions and Global/Submission Content Plans.
Act as the main liaison between internal stakeholders and external partners to ensure timely submission and archival in Veeva Vault RIM.
Stay up to date with global regulatory guidance and ensure compliant operational activities.
Represent submission management on regional/global regulatory workstreams.
Ensure SOPs and procedures are followed for publishing and processing of regulatory documents.
Support communication strategy with global health authorities.
Lead or contribute to process improvement initiatives and system/software updates.
Participate in validation projects for regulatory systems and platforms.
Required Knowledge and Skills
Advanced technical and project management skills with experience leading regulatory teams.
Expertise in eCTD, NeeS, and paper submission formats (originals, amendments, reports, promotional materials, etc.).
Strong knowledge of Veeva Vault RIM including Global/Submission Content Plans and reporting tools.
Familiarity with global and emerging market marketing application requirements and country-specific guidelines.
Proficiency with eCTD publishing tools (e.g., Lorenz docuBridge Explorer).
Knowledge of software validation practices for regulatory systems.
Preferred Knowledge and Skills
Deep understanding of Veeva Vault RIM.
Strong regulatory knowledge of clinical trial and marketing applications for global markets.
Proven ability to coordinate across departments like Clinical, CMC, Labeling, Safety, and Regulatory Strategy.
Effective in managing regional/multi-country submission timelines and execution.
Education and Experience Requirements
Basic:
Master’s degree with 3–4 years of relevant experience
OR
Bachelor’s degree with 4–6 years of relevant experience
OR
Associate’s degree with 6–8 years of relevant experience
OR
High school diploma/GED with 8+ years of relevant experience
Preferred:
Practical experience with submission requirements in US, Canada, and South America
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Rangpo |India :
Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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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 :
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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 :
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Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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King Abdullah Economic City | Khulais | Riyadh | Rabigh | Najran | Jeddah |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
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