Regulatory Affairs Executive
2 days ago
Company Description
Uniza 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 Respiratory therapies. Since its inception in 2020, Uniza has expanded into Southeast Asian, African, and Latin American markets, filing dossiers in over 30 countries. The company's manufacturing unit holds multiple international approvals.
Role Description
This is a full-time on-site role for a Regulatory Affairs Executive based in Ahmedabad. The Regulatory Affairs Executive will be responsible for preparing and submitting regulatory documents, ensuring compliance with regulations, updating and maintaining regulatory files, and coordinating with various departments. Additional tasks include reviewing labeling and promotional materials to ensure compliance and staying up-to-date with industry standards and regulations.
Qualifications
- Experience in preparing and submitting regulatory documents
- Understanding of industry regulations and compliance requirements
- Ability to update and maintain regulatory files and documentation
- Coordination skills to work with different departments
- Attention to detail and strong analytical skills
- Excellent written and verbal communication skills
- Bachelor's degree in Pharmacy, Life Sciences, or a related field
-
Regulatory Affairs
6 days ago
Ahmedabad, Gujarat, India VITAL INTELLIGENCE TECHNOLOGY PRIVATE LIMITED Full time ₹ 30,00,000 - ₹ 60,00,000 per year**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
1 week ago
Ahmedabad, Gujarat, India Morgan Placement Full time ₹ 12,00,000 - ₹ 36,00,000 per yearSeeking 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.
-
Senior Regulatory Affairs Specialist
2 weeks ago
Ahmedabad, Gujarat, India Jain Soap & Jain Lifecare Pvt Ltd Full time ₹ 32,00,000 - ₹ 48,00,000 per yearJob 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...
-
Regulatory Affairs Associate
4 days ago
Ahmedabad, Gujarat, India Smart Lion Full time ₹ 4,00,000 - ₹ 12,00,000 per yearRegulatory Affairs Associate Responsible for preparation, review & submission of regulatory documents (US FDA, EMA, ICH), ensuring compliance with guidelines, supporting product approvals, maintaining records & coordinating with authorities. Required Candidate profileBSC/MSC/B.Pharm or Life Sciences graduate with knowledge of regulatory guidelines, dossier...
-
Manager- Drug Regulatory Affairs
2 weeks ago
Ahmedabad, Gujarat, India Lezivia Lifesciences Full time ₹ 15,00,000 - ₹ 25,00,000 per yearCompany 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,...
-
Regulatory Affairs Manager
2 weeks ago
Ahmedabad, Gujarat, India Red Envelope Consultants Full time ₹ 15,00,000 - ₹ 25,00,000 per yearJob 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...
-
AGM-GRA (Regulatory Affairs)
1 week ago
Ahmedabad, Gujarat, India Kashiv BioSciences LLC. Full time ₹ 15,00,000 - ₹ 25,00,000 per year: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,...
-
Ahmedabad, Gujarat, India Lezivia Lifesciences Full time ₹ 8,00,000 - ₹ 12,00,000 per yearCompany 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...
-
Senior Regulatory Affairs Executive
2 weeks ago
Ahmedabad, Gujarat, India White Force Group Full time ₹ 8,00,000 - ₹ 12,00,000 per yearCTC - 8 LpaExp - 5+ yearsYour Key Responsibilities● Dossier Preparation & Compilation: Lead and oversee the preparation, review, and submission ofregulatory dossiers in CTD, ACTD, and eCTD formats for global markets, ensuring compliance withcountry-specific guidelines.● Regulatory Strategy & Market Compliance: Develop and execute regulatory strategies...
-
Regulatory Affairs
4 days ago
Ahmedabad, Gujarat, India Medwise Overseas Full time ₹ 5,00,000 - ₹ 15,00,000 per yearRoles 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)...