Licensing and Regulatory Affair

**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. -...

Hiring for a **REGULATORY AFFAIRS EXECUTIVE** for our **Ahmedabad **location. **Key Responsibilities**: - Assist in the preparation, compilation, and submission of regulatory documents, such as drug master files (DMFs), technical dossiers, and regulatory filings, to health authorities and regulatory agencies. - Maintain and update regulatory documentation...

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...

Title/Designation: Executive - Regulatory Affairs Reports to: RA Manager Based at: Ahmedabad Industry: class III Medical Device Qualification : B.pharm, M.pharm or Msc Job description An exciting opportunity to work for class III / Class -D medical device certification & regulations Key responsibilities/ accountabilities: For the above position, your...

Regulatory affairs executive - B Pharm or M Pharm with 2 years plus experience in similar profile or work area. **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...

POSITION : REGULATORY AFFAIRS QUALIFICATION : B. PHARM, M. PHARM, (B.S.C, M.S.C) EXPERIENCE : 0.6 TO 3 JOB LOCATION : AHMEDABAD MO. 7383005000 SHIVANI WINSTON HR SERVICES **Salary**: ₹20,000.00 - ₹30,000.00 per month Schedule: - Day shift **Experience**: - total work: 1 year (preferred) Work Location: In person **Speak with the...

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...

**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...

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...

Title/Designation:                   Senior Regulatory ExecutiveBased at:                                 AhmedabadIndustry:                                 Medical Devices manufacturing (Class...

Title/Designation:                   Senior Regulatory Executive Based at:                                 Ahmedabad Industry:                                 Medical Devices manufacturing (Class III)...

Title/Designation:                   Senior Regulatory ExecutiveBased at:                                 AhmedabadIndustry:                                 Medical Devices manufacturing (Class...

Title/Designation:                   Senior Regulatory ExecutiveBased at:                                 AhmedabadIndustry:                                 Medical Devices manufacturing (Class...

M Pharm or B Pharm with 2 years plus experience in regulatory affairs required urgently. Preparing Dossiers for registration of products in various markets - Knowledge of CTD format is mandatory - Should have knowledge of Production and QA - Prior experience in preparing Dossiers is mandatory - Basic knowledge of Microsoft Word and Excel is...

Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy - Timely compile materials for license renewals, updates and registrations - Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking...

**Job description** Key Responsibilities: - **1. Dossier Preparation**_ a) Review documents received from the manufacturing facilities b) Compilation of documents as per guidelines of the respective country c) Compilation of dossier as per country guideline d) Follow up with the sites for documents, samples, and artwork e) Resolving query raised by...

**Qualification**: B. Pharm / M. Pharm-RA **Experience**: 2 to 3 Years **Description**: - Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority. - Well versed with the guidelines of ICH and other regulatory. - Preparation of documents for COPP, FSC, and other legal documents including product...

Title/Designation:Senior Regulatory Executive Based at:Ahmedabad Industry:Medical Devices manufacturing (Class III) Qualification:Postgraduate or equivalent in Pharma/Medical Devices domainExperience:5-6 years min. Reports to:Head of QA/RA About us: Aegis Lifesciences, established in 2008, is a distinguished manufacturer and exporter of medical devices,...

Qualification: B. Pharm / M. Pharm-RA Experience: 3 to 6 Years Description: - Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority. - Well versed with the guidelines of ICH and other regulatory. - Preparation of documents for COPP, FSC, and other legal documents including product permission -...