Regulatory Affairs Specialist –

3 weeks ago

Varanasi, India vueverse. Full time

Key Responsibilities:Regulatory Submissions & ComplianceAuthor, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others.Conduct dossier gap analysis to identify document and data gaps across all CTD modules (1–5).Convert and prepare dossiers in multiple formats including eCTD, ACTD, and CTD.Manage end-to-end preparation and submission of ANDA, NDA, BLA, MAA, and other lifecycle submissions (variations, renewals, withdrawals).Coordinate responses to health authority queries through cross-functional collaboration and data collation.Maintain a strong command over CMC, clinical, non-clinical, and administrative documentation to ensure successful global submissions.Project Planning & ManagementManage regulatory submissions for multiple products across multiple countries simultaneously.Utilize project management tools to track project milestones, timelines, and deliverables.Ensure efficient time and resource allocation to meet submission deadlines.Foster seamless communication between central regulatory, regional teams, and client stakeholders.Requirements:8–10 years of core experience in Regulatory Affairs, handling submissions across regulated and RoW markets.Strong understanding of global dossier formats, submission pathways, and lifecycle management.Excellent cross-functional communication and coordination skills.Proven ability to manage complex multi-country regulatory portfolios.

  • Regulatory Affairs Manager

    6 days ago

    Varanasi, India Ixoreal Biomed Full time

    About the Company: Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts. Title: Manager/Senior Manager- Global Regulatory Affairs Experience: 8–12+ years of Regulatory Affairs experience in Nutraceuticals, Dietary Supplements,...

  • Global Regulatory Specialist

    1 week ago

    varanasi, India beBeeRegulatory Full time

    Regulatory Affairs Lead Role OverviewThis role entails overseeing regulatory submissions for multiple products across diverse markets.Prepare and submit regulatory dossiers to global health authorities such as USFDA, EMA, MHRA, and others.Coordinate responses to health authority queries through cross-functional collaboration and data collation.Key...

  • Fintech Regulatory Compliance Specialist

    2 weeks ago

    varanasi, India beBeeCompliance Full time

    Job Title: Legal & Compliance Head | FintechWe are seeking a seasoned professional to lead our legal and compliance efforts in the fintech industry. The ideal candidate will have deep knowledge of SEBI RIA and AMFI/ARN regulations, ensuring strict arm's-length separation between advisory and distribution businesses.Key Responsibilities:Compliance Management:...

  • Kyc / aml due diligence

    3 weeks ago

    Varanasi, India AKM Global Full time

    As a KYC/AML Due Diligence Specialist, you will be a key member of our White Collar crime defense team, advising clients—including leading global financial institutions—on building and managing robust anti-money laundering (AML) and counter-terrorist financing (CFT) programs. Your work will involve conducting in-depth due diligence, investigating...

  • Manager - Operations

    1 week ago

    Varanasi, Uttar Pradesh, India Birla Fertility & IVF Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Company DescriptionBirla Fertility & IVF is part of the CKA Birla Group, an Indian multinational conglomerate with over 35,000 employees operating in diverse sectors such as technology, automotive, home and building, and healthcare. We are dedicated to transforming the future of fertility globally through reliable, innovative, and research-driven fertility...

  • Corporate & Business Legal Advisor

    1 week ago

    Shivpur, Varanasi, Uttar Pradesh, India Techhansa solutions Full time

    **Objectives of this role** - Expertise in commercial law, corporate and business law - Provide legal advice that complies with regulatory laws, keeping in mind the ethos of the company - Ensure that the company avoids all kinds of legal risks and violations with the right corporate law services - Evaluate ongoing and potential projects for the company and...

  • Product Specialist- Asset Liability Management

    1 week ago

    Varanasi, India Acies Full time

    Highlight of the engagement opportunity Nature of role: Full time Number of years of experience expected: 3-7 Years Areas of part experienced preferred: Asset-liability management (ALM) / Liquidity risk / IRRBB / Risk consulting Educational qualification expected: Bachelor’s degree in Engineering / Economics / Statistics / Mathematics Additional...