Regulatory Affairs Executive

**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. -...

Vega Biotec Pvt Ltd forms part of Vega group companies involved in manufacturing and exporting of finished pharmaceutical products and having global presence in 20+ countries. We have an opening for the following post. 1. Regulatory Affairs Executive - Qualification - Bsc. Chem/B.pharma/M.pharm Experience - 1 year minimum Job profile: 1. To assist manager...

**Role & responsibilities** - EU Dossier preparation and submission to Europe market. - EU ASMF and CEP preparation and submission to Europe with post-approval activities - Handling of EDQM Agency Queries. - Brazilian DMF Preparation and Deficiency response. - China DMF Preparation and Deficiency response. - eCTD publishing in EDUCE software with PDF...

**Job Title**: Regulatory Affairs Executive **Department**: Regulatory Affairs (RA) **Location**: Sola, Ahmedabad **Job Summary**: **Key Responsibilities**: - **Preparation and Compilation**: - Prepare registration dossiers in CTD, ACTD, or country-specific formats as per regulatory requirements. - Arrange and organize registration documents according...

Regulatory Affairs LeaderWe are seeking an experienced Regulatory Affairs professional to join our team.The ideal candidate will have extensive experience in managing regulatory affairs for pharmaceutical products, including dossier compilation, submission, and query response. This role requires strong leadership skills, attention to detail, and excellent...

**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,...

Job Title:Regulatory Affairs ManagerWe are seeking a seasoned Regulatory Affairs Manager to join our regulatory team. This role will be responsible for developing and directing global regulatory strategies, leading the preparation of submission dossiers, and collaborating with cross-functional teams.Key Responsibilities:Develop and direct global regulatory...

Sunrise Remedies Job Opening for Regulatory Affairs Executive (RA). **Experience**: 0 To 1 Year **(Fresher and Experience Can Also Apply)** **Industries**: Pharmaceutical Company **Education**: B.Sc. / M.Sc / B.Pharm / M.Pharm **Job Location**: Santej Ahmedabad **Key Responsibilities**: - Regulatory Affairs Specialists assist in obtaining and maintaining...

Regulatory affairs executive - B Pharm or M Pharm with 2 years plus experience. **Job description**: - Preparing Dossiers for registration of products in various ROW markets and query response submission - Legalization of FDCA documents for respective country registration - Arrangement of Sample for registration submission from respective team - Prior...

Regulatory Affairs Pre-Approval - Injectable & Complex Injectables Executive / Senior Executive / Assistant Manager / Deputy Manager / Manager Experience: 03-10 Years Budget: 05-25 LPA ANDA Filling exposure for USA Market for Injectable and Complex Injectable products. Pre-Approval experience required.