Regulatory Affairs Associate

**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...

Seeking a Regulatory Affairs professional (5–12 yrs exp, US FDA focus) to manage product approvals, ensure compliance, and liaise with regulatory bodies. B.Pharm/M.Pharm required.

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...

Company DescriptionLezivia Lifesciences is a reputed company known for its quality pharmaceutical products. Most of our products are manufactured at WHO-approved facilities, ensuring the highest quality standards for patient care. We are dedicated to delivering the best products to improve patient outcomes and well-being.Role DescriptionThis is a full-time,...

Job Title:Sr. Regulatory ExecutiveLocation:Vadsar, GandhinagarCTC:₹4.0 LPA – ₹6 LPAExperience Required:2–4 years in Regulatory Affairs (Pharma or Cosmetics)Educational Qualification:B.Pharm / M.Pharm – Drug Regulatory Affairs, Quality Assurance, Pharmacology, or Pharmaceutical AnalysisRoles & Responsibilities:Prepare and review dossiers in...

Job Title: Senior Regulatory Manager – RoW MarketDepartment: Regulatory AffairsJob Summary:The Senior Regulatory Manager will be responsible for the preparation, review, and submission of high-quality regulatory dossiers and documents for pharmaceutical products intended forRest of the World (RoW) markets, ensuring compliance with country-specific...

:Lead/support emerging markets (and Japan, Canada, ANZ) filing for Biosimilars, NCEs &ANDAs,Query responses, audit support, and lifecycle management.Regulatory support for the filing of IND/CTA to various regulatory agencies.Maintenance of IND/CTA through submission of protocol amendments, addition of investigators, EC approvals, SAE report submission,...

Company DescriptionLezivia Lifesciences is a well-regarded company, known for its commitment to providing high-quality pharmaceutical products. Most of its products are manufactured at WHO-approved facilities, ensuring the best quality for patients. Lezivia values innovation and excellence in healthcare solutions.Role DescriptionThis is an on-site full-time...

Roles and ResponsibilitiesResponsible for preparation & compilation of the dossiers in CTD/eCTD/ACTD and other formats as required for submission to different regulatory authorities.Review the documents i.e. Specifications, Batch Records, STP, Stability Protocol, Dissolution protocols & DMF documents etc.Preparation of pharmaceutical/quality part (all forms)...

Company DescriptionBiotek Ortho is a global medical device company specializing in cutting-edge innovation within the orthopedic sector, particularly in sports medicine and extremities. With a strong presence across six continents, Biotek continues to experience robust growth and demand for its high-quality products. Despite its global reach, Biotek remains...