Regulatory Affairs

**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...

**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...

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...

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...

Vega Biotec Pvt Ltd forms part of Vega group companies having state of the art manufacturing company in Vadodara and having presence in over 20 countries. Our export arm has an opening for the following post.1. Senior Regulatory affairs executive-Qualification- Bsc/Msc Chem,B.pharma/M.pharmaExperience- Minimum 4 years in RAJob Profile-1. CTD or ACTD dossier...

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...

Position Regulatory Affairs Associates Location - Vadodara KRA: As a RA Sr. Officer Reviewing artwork, PRAC variations, CEP updates for EU market. Preparation of Regulatory Strategic documents for EU/UK market. Review and compilation of deficiencies response for ROW (specially MENA, LATAM market) Compilation and submission of renewal, variation for...

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...

Company OverviewRenown Pharmaceuticals Pvt. Ltd. is a reputable soft gelatin contract manufacturer with a state-of-the-art facility in Vadodara, India. The company upholds the highest quality standards and aims to be a top producer of soft gelatin capsules in India. Renown Pharma is known for its adherence to regulatory standards like MHRA, TGA, and WHO-GMP,...

Company Overview Renown Pharmaceuticals Pvt. Ltd. is a reputable soft gelatin contract manufacturer with a state-of-the-art facility in Vadodara, India. The company upholds the highest quality standards and aims to be a top producer of soft gelatin capsules in India. Renown Pharma is known for its adherence to regulatory standards like MHRA, TGA, and...

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...

We are Hiring Regulatory Affairs Specialist for Medical Devices (Orthopedic Implants and Instruments) Role & Responsibilities: 1. Documents preparation for ISO13485, CE Certificate (EU MDR), USFDA. 2. Work on technical master file. 3. Work on CERs (clinical evaluation report) 4. Have knowledge about QMS (quality management systems). 5. Reporting to...

Job Description: Job Description: Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations. ? Preparation, Compilation & Review of Registration documents that include Administrative & Technical. ? Reviewing the technical documents provided by QA, QC,...

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...

**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...

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 - B.pharma/M.pharm Experience - 2 -5 years minimum Job profile: 1. Dossier compilation for...