Regulatory Affairs Executive

3 hours ago

Ahmedabad, India BKM Health Pvt Ltd Full time

Regulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like Extedo, Lorenz, Veeva Vault RIMJob Responsibility: Prepare, compile, and review eCTD dossiers for submissions (e.g., ANDA/NDA /MAA/ANDS).Coordinate with cross-functional teams (QA, QC, R&D, Manufacturing, Packaging) for accurate documentation.Submit applications to US FDA, HC, EMA, and other authorities in compliance with regional requirements.Compile and validate submissions using tools such as Extedo, Lorenz docuBridge, or equivalent.Ensure completeness and technical accuracy of eCTD sequences.Troubleshoot validation issues before final submission.Prepare and manage post-approval changes (CMC variations, labeling updates, packaging changes).Submit supplements, amendments, and variations in accordance with regulatory guidelines (FDA’s PAS, EMA's Type IA/IB/II).Collaborate with internal departments to gather data and draft scientifically sound responses.Stay updated with changes in FDA, EMA, and ICH guidelines.Maintain regulatory databases, submission trackers, and approval records.Participate in audits and support regulatory inspections.Required Qualification & Skills: Bachelor's / Master’s degree in Pharmacy or related field. 1.5 – 2 years of relevant experience in Regulatory Affairs for regulated markets (Health Canada/US/EU)In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks.Strong understanding of dossier structure, eCTD publishing, and submission timelines.

  • Regulatory Affairs

    2 weeks ago

    ahmedabad, India VITAL INTELLIGENCE TECHNOLOGY PRIVATE LIMITED Full time

    **Vivanza Biosciences Limited** is seeking a highly motivated and detail-oriented professional to join our team as a **Regulatory Affairs Executive** in Ahmedabad, Gujarat. This role is ideal for an individual with foundational experience in the pharmaceutical industry who is keen to grow their career in regulatory compliance and submissions for global...

  • Regulatory Affairs Executive

    12 hours ago

    Ahmedabad, India BKM Health Pvt Ltd Full time

    Regulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...

  • Regulatory Affairs Executive

    39 minutes ago

    Ahmedabad, India BKM Health Pvt Ltd Full time

    Regulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...

  • Regulatory Affairs Executive

    11 hours ago

    Ahmedabad, India BKM Health Pvt Ltd Full time

    Regulatory Affairs Executive : (BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...

  • Regulatory Affairs Executive

    20 hours ago

    Navrangpura, Ahmedabad, Gujarat, India Bexcode Services Full time

    **Regulatory Affairs Executive Job Description** **Job Summary**: The Regulatory Affairs Executive will work with product development and manufacturing management to ensure that the product development process meets all applicable regulatory requirements. **Duties/Responsibilities**: - Works in the regulatory affairs department on assigned projects. -...

  • Regulatory Affairs

    4 days ago

    Ahmedabad, Gujarat, India Medipharma Konnect Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    We are hiring Regulatory Affairs (RA) Executive / Manager for a leading Pharma company in Ahmedabad. The candidate will be responsible for dossier preparation, product registration, regulatory submissions, and maintaining compliance with international guidelines (ROW / LATAM / Africa). Must have hands-on experience in RA documentation for pharma...

  • Regulatory Affairs Executive

    2 weeks ago

    Ahmedabad, Gujarat, India Uniza Group Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Company DescriptionUniza is part of the $150 M+ Pashupati group of companies, specializing in India Business, International Business, and the manufacturing of tablets, capsules, creams, and ointments. With a strong distribution network across 28 states in India, Uniza has established a significant presence in Dermatology, Cardio-Diabetic, Gynecology, and...

  • Regulatory Affairs Executive

    4 days ago

    Ahmedabad, Gujarat, India nutralike formulation Pvt Ltd Full time ₹ 4,00,000 - ₹ 8,00,000 per year

    Nutralike is a leading nutraceutical manufacturer offering premium-quality products across tablets, capsules, powders, and syrups. With global compliance standards and presence across ROW, Middle East, EU, CIS, and GCC markets, Nutralike focuses on innovation, safety, and quality. Learn more at Job Summary:The Regulatory Affairs Executive will be...

  • Regulatory Affairs Executive

    21 hours ago

    Jagatpur, Ahmedabad, Gujarat, India Pharmaceutical Distributor Full time

    **Introduction**: We are seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like Extedo, Lorenz,...

  • Regulatory Affairs Executive

    1 week ago

    Vatva Gidc, Ahmedabad, Gujarat, India Samarthhrconsultant Full time

    Regulatory Affairs Executive B.Pharm / M.Pharm 2-4 years vatva Ahrmdabad Pay: From ₹12,000.00 per month **Experience**: - total work: 1 year (preferred) Work Location: In person Application Deadline: 21/01/2025 Expected Start Date: 19/12/2024