International Regulatory Affairs

**Qualification**: B.Pharma - Pharmacy or M.Pharma - Pharmacy **Experience**: 2.0 Year **To** 4.0 Year **( Must have experience in Pharma Formulations)** 1. Preparing dossiers as per country specific guidelines 2. Countries knowledge - Africa, South East Asia They must have excellent organizational, analytical, project management, and communication...

**Position**: Regulatory Affairs Specialist **Location**: Odhav. Ahmedabad **Department**: Regulatory Affairs **Reports to**: Regulatory Affairs Manager / Director Job Summary: Key Responsibilities: - **Compliance Monitoring**: Monitor changes in regulations and guidelines to ensure ongoing compliance with local and international regulations. -...

**About us**: (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,...

(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...

**Vega Biotec Pvt Ltd** a part of Vega group of companies having global presence and state of the art manufacturing pharmaceutical factory is having an opening for the following post. Qualification - B.Pharm/ M. Pharm Experience - 3+ years of experience in regulatory affairs for ROW market (Rest of the world) **Job Summary**: The Regulatory Affairs...

**Qualifications**: Any Graduate of B.Pharm / M.Pharm / MBA (pharmaceuticals/IB) / M.sc / Any Relevant Degree in Pharmaceuticals. **Roles & Responsibility**: - To ensure that a company's products comply with the regulations of the regions where they want to distribute them - To develop explanations for new product licenses and license renewals to strict...

**Executive: International Regulatory Affairs & Product Management** **Key Responsibilities for International Regulatory Affairs** - **Global Regulatory Strategy Development**: - Determine pathways for product approvals in different markets (e.g., EMA in Europe, South East Aisa, Latum, USA, etc.) - Understand varying regulatory landscapes and...

**Job Description**: Prepare, review and submit regulatory dossiers for product registrations. Ensure all necessary documentation is accurate, complete and meets regulatory requirements. Collaborate with cross-functional teams to ensure compliance with global regulatory standards. Conduct regulatory research and stay updated on international regulatory...

**Job Description**: Prepare, review and submit regulatory dossiers for product registrations. Ensure all necessary documentation is accurate, complete and meets regulatory requirements. Collaborate with cross-functional teams to ensure compliance with global regulatory standards. Conduct regulatory research and stay updated on international regulatory...

**Position : Regulatory Affairs Officer/Executive (Female)** **Education : B Pharm (Preferably)** **Experience : 1-2 Years** **Work Profile**: 1. Preparation & Checking of Dossiers of formulation products for product registration in other countries. 2. Co-ordination with Manufacturer & our partner in country (With their regulatory person) 3. Travel may...