Regulatory Affairs Manager (Remote – India)
Location: Remote, India
Job Type: Full-Time
Category: Clinical Research
Work Model: Fully Remote
Job Overview
Thepharmadaily.com is featuring an excellent opportunity for an experienced Regulatory Affairs Manager to join a leading global clinical research organization. This position is ideal for regulatory professionals seeking to contribute to impactful global clinical trials across Phases I–IV while advancing their strategic and technical expertise in regulatory operations.
As part of the global Regulatory Affairs department, you will provide regulatory leadership, manage regulatory strategies, and ensure compliance with international guidelines. The role involves close collaboration with clients, internal teams, and global health authorities.
Key Responsibilities
Lead the development and submission of global regulatory dossiers, ensuring alignment with local, regional, and ICH requirements.
Serve as a subject matter expert, providing regulatory strategy, intelligence, and technical guidance to internal teams and external clients.
Support regulatory planning across assigned clinical trials and product development stages.
Deliver up-to-date regulatory guidance to clients and internal stakeholders as new legislation and updates become available.
Oversee project delivery quality, resource allocation, and project timelines.
Manage budget forecasts and identify out-of-scope activities in line with contract terms.
Collaborate with business development teams by providing client presentations, proposal text, and regulatory input for new business opportunities.
Lead and mentor junior team members through matrix and project leadership.
Ensure compliance with internal SOPs, regulatory standards, and quality procedures.
Coordinate and participate in client meetings, regulatory agency interactions, and project review discussions.
Experience Required
Minimum 5 years of relevant regulatory affairs experience within the clinical research, pharmaceutical, or CRO environment.
Proven expertise in project management and client-facing regulatory roles.
Experience with EUCTR, scientific advice procedures with EMA, and interactions with EU Health Authorities.
Strong understanding of regulatory requirements for clinical trial applications, lifecycle management, and global regulatory frameworks.
Education
Bachelor’s degree in a scientific or regulatory discipline required.
Advanced degree preferred (Life Sciences, Pharmacy, Regulatory Affairs, or related field).
Skills and Competencies
Strong command of written and spoken English; additional local languages (if applicable) are an asset.
Excellent attention to detail with strong editorial and proofreading capabilities.
Ability to work collaboratively across departments and act as a primary liaison for regulatory discussions.
Advanced proficiency in Microsoft Word, Excel, PowerPoint, and willingness to learn new platforms.
Strong planning, analytical, and time management skills to manage multiple regulatory projects.
Effective negotiation and communication skills for cross-functional and client interactions.
Ability to work independently, exercise sound judgment, and evaluate regulatory needs for compliant deliverables.
Deep knowledge of global, regional, and national regulatory guidelines, ICH requirements, and clinical trial authorization procedures.
Strong budgeting, forecasting, and problem-solving skills.
Why This Opportunity Stands Out
Work within a high-performing global regulatory team supporting complex clinical research programs.
Engage directly with international clients, regulatory agencies, and cross-functional scientific experts.
Advance your regulatory expertise in a global environment committed to innovation, quality, and scientific excellence.
Fully remote role designed to support work-life integration while contributing to meaningful health outcomes.
If you want, I can also provide:
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Rangpo |India :
Siliguri |Illinois :
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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 :
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Bangor | Brewer |New Jersey :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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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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Auckland |New Zealand :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Netanya | Tel Aviv | Yavne | Kfar Saba | Be'Er Sheva |Remote :
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Brentwood |Bucharest :
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Khulais | Riyadh | King Abdullah Economic City | Jeddah | Najran | Rabigh |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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