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. -...

**Job Summary**: The Regulatory Affairs Executive will be responsible for preparing, reviewing, and submitting regulatory dossiers for nutraceutical products intended for Rest of the World (RoW) markets. The role ensures compliance with country-specific requirements and involves coordination with internal teams, distributors, and regulatory agents for timely...

**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. -...

**Job Role: Regulatory Affairs (RA) Head (Male preferred)** **Responsibilities**: - Oversee regulatory submissions, compliance, and approvals for products. - Ensure adherence to international and local regulatory requirements. - Develop and implement regulatory strategies to support business objectives. - Lead communication with regulatory authorities and...

About Us:Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...

**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...

**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,...