Regulatory Affairs Specialist
Location: Remote, India
Job ID: R-01334432
Employment Type: Full-Time
Category: Clinical Research
Work Mode: Fully Remote
About the Role
The Regulatory Affairs Specialist plays a key role in supporting regulatory submission activities and documentation aligned with EUCTR requirements. Working within a leading global clinical research organization (CRO), this role directly contributes to the successful development of therapies that address major global health challenges. You will collaborate with cross-functional teams, manage regulatory deliverables, and ensure compliance with current regulatory guidelines and organizational standards.
Key Responsibilities
Support the preparation, coordination, and submission of regulatory documentation in accordance with EUCTR guidance.
Manage and maintain RIMS documentation with strong understanding of regulatory information management systems.
Coordinate client deliverables to ensure regulatory compliance and timely completion of project activities.
Communicate with internal teams and external clients to track project status, update timelines, and support ongoing deliverables.
Maintain a strong working knowledge of SOPs, client directives, and current regulatory guidelines.
Assess client requirements in relation to timelines, quality expectations, and project objectives.
Collaborate with project teams, functional departments, and management to ensure successful project execution and resolve any delivery challenges.
Provide project-specific documentation, reporting, and coordination to internal and external stakeholders.
Support bid and proposal development, including data generation, analysis, contract modifications, and bid defense preparations.
Education and Experience Requirements
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field.
Minimum 2 years of relevant experience in regulatory affairs, clinical research, or documentation management.
Demonstrated experience supporting regulatory submissions and working with RIMS or regulatory documentation systems.
Work Schedule
Standard Monday to Friday
Remote work environment
Why Join
This role provides the opportunity to work within a high-performing global research environment, contribute to impactful drug development initiatives, and engage with international teams driving regulatory excellence.
Gujarat :
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Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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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 :
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Sheffield |Oxfordshire :
Witney |Ontario :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |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 :
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Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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Paris | Lyon |South Africa :
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Santiago |Bosnia and Herzegovina :
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