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Regulatory Affairs Specialist

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Join PLG as a Regulatory Affairs Specialist in India. Ensure UK & EU compliance for medicinal products, managing MAAs, lifecycle maintenance, and post-approval activities. Ideal candidates have 3-7 years' experience with MHRA/EMA, CTD/eCTD, and regulatory systems. This role offers a dynamic envir...
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Location
India
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Not provided
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Product Life Group
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Senior Regulatory Affairs Consultant

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Lead U.S. regulatory strategy for biotech and pharma clients at ProductLife Group. This senior consultant role requires 10-15 years' FDA experience, expertise in INDs/NDAs/BLAs, and direct Health Authority interaction. Provide strategic leadership and act as a trusted advisor in this client-facin...
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Location
United States
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Salary
170000.00 - 210000.00 USD / Year
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Regulatory Affairs Specialist

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Join PLG as a Regulatory Affairs Specialist in Poland. You will manage the full product lifecycle, ensuring global compliance for medical products. The role requires 5-10 years of Polish market experience with MAA, CTD, and post-approval processes. Fluency in English and Polish is essential for t...
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Poland
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Not provided
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Ra officer

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Seeking a Regulatory Affairs Officer with 3+ years' experience, specializing in TGA and Medsafe submissions. You will manage pharmaceutical and medical device registrations for Australia, New Zealand, and the JAPAC region from India. This role requires strong dossier preparation, eCTD publishing,...
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Location
India
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Not provided
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Information and Documentation Officer

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Join ProductLife Group as an Information and Documentation Officer in India. Utilize your pharmacy/life sciences degree and pharmacovigilance knowledge to perform critical literature monitoring. You will conduct searches in PubMed/ADIS, manage documentation, and support quality systems. This role...
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Location
India
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Not provided
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Product Life Group
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Regulatory Publishing Expert/Lead

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Lead global regulatory submissions for a top consulting firm. Manage end-to-end eCTD publishing using DocuBridge/EXTEDO, ensuring compliance for NDAs, BLAs, and life-cycle filings. This hands-on expert role requires 8+ years' experience and offers leadership of a publishing team.
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Location
United States
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Not provided
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Product Life Group
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Case Specialist – Vigilance / Case Management

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Join our Case Management team in the Philippines as a Vigilance Case Specialist. Utilize your life sciences degree and 3-6 years of pharmacovigilance experience to ensure end-to-end, compliant case handling. You will perform QC, medical review, and analysis, directly impacting patient safety for ...
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Philippines
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Not provided
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Product Life Group
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Case Specialist-Pharmacovigilance

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Philippines
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Not provided
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Product Life Group
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Coordinator

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India
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Not provided
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Product Life Group
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Case specialist

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India
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Not provided
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Integration Specialist

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Product Life Group
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Data Officers (Pharmacovigilance)

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Join ProductLife Group as a Data Officer in Pharmacovigilance. Utilize your 2+ years of PV experience and knowledge of UK/EU regulations to manage safety case processing and ICSR follow-up. This remote role in the Philippines requires working UK hours, offering a key position within a dynamic, cl...
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Philippines
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Not provided
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Product Life Group
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