Officer - Plant Regulatory Affair Department
4 hours ago
Roles and Responsibilities
- Prepare dossiers for US FDA, including CTD format.
- Ensure regulatory compliance with RA requirements.
- Manage parenteral products' dossier preparation and submission to regulatory authorities.
- Coordinate with cross-functional teams for injectable product development and registration.
- Track regulatory updates and maintain records in Trackwise system.
Desired Candidate Profile
- 1-4 years of experience in Dossier Preparation, Regulatory Affairs (RA), or related field.
- M.Pharma degree from a recognized institution.
- Strong understanding of drug regulatory affairs, particularly in the US market (USFDA).
- Proficiency in preparing dossiers according to CTD format.
-
Regulatory Affairs
2 weeks 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 Uniza Group Full time ₹ 6,00,000 - ₹ 12,00,000 per yearCompany 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
3 hours ago
Ahmedabad, Gujarat, India Medipharma Konnect Full time ₹ 12,00,000 - ₹ 36,00,000 per yearWe 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 Associate
1 week 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...
-
Regulatory Affairs Executive
2 weeks 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 Executive
4 days ago
Ahmedabad, Gujarat, India Synerxia Healthcare Full time ₹ 5,00,000 - ₹ 12,00,000 per yearJob descriptionSYNERXIA Healthcare Pvt Ltd is engaged into Manufacturing & Exports of Nutraceuticals-Health/Dietary Supplements along with Pharmaceutical Products, is one of the Upstart organization is looking for position in Regulatory Affairs - Emerging / ROW Market for pre-submission and post-submission.Role and responsibilities Responsible for...
-
Regulatory Affairs Executive
8 hours ago
Ahmedabad, Gujarat, India nutralike formulation Pvt Ltd Full time ₹ 4,00,000 - ₹ 8,00,000 per yearNutralike 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...
-
Deputy Regulatory Affairs Manager
16 minutes ago
Ahmedabad, Gujarat, India Opes Healthcare Full time ₹ 4,00,000 - ₹ 12,00,000 per yearRole & responsibilitiesTo lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats.Responsible for final review of dossier before submission.Reviewing artwork for products as per relevant regulatory authority requirements.Coordination with F&D, QA, QC & Store for documentationIn-depth knowledge of pharmaceutical documentation &...
-
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...
-
Regulatory Affairs
2 weeks ago
Ahmedabad, Gujarat, India Biotek Ortho Full time ₹ 12,00,000 - ₹ 36,00,000 per yearCompany 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...