Regulatory Affairs Officer

**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 - B.pharma/M.pharm Experience - 5-7 year's minimum in regulatory affairs Job profile: 1....

Hiring for a **REGULATORY AFFAIRS OFFICER ** for our **Ahmedabad **location. Freshers with good knowledge should apply **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. -...

Job description **Company Description** Briyosis Soft Caps Pvt. Ltd. is a privately-owned contract manufacturer of custom dietary supplement formulations. Based in Vadodara, India, we are an FDA registered and WHO-GMP certified company. With our high-efficiency encapsulation lines operating 24/7, we have the capability to produce over 3 billion soft-gels...

Looking for an Enthusiastic, Efficient & Trustworthy Senior Executive - Regulatory Affairs for a Leading MNC “**Ronak Group”** **Company: Ronak Group (MNC)** Position**:Executive / Senior Executive - Regulatory Affairs** Experience: 2 to 7 Years Location: Vadodara, India We are looking for Energetic & Goal Oriented **Executive / Senior Executive -...

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 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. -...

**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...

**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 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...

Regulatory Affairs (Asia Pacif & Africa) (Female B.Pharm / M.Pharm Executive / Sr Executive 3-6 Years Sanand Ahemdabad Pay: From ₹12,000.00 per month Work Location: In person Application Deadline: 10/06/2024 Expected Start Date: 08/05/2024

DETAILS: Experience in regulatory affairs for ROW market EXPERIENCE: 2-3 years EDUCATION: B. Pharm/ M. Pharm LOCATION: Ahmedabad, India

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...

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.Senior Regulatory affairs executive-Qualification- Bsc/Msc Chem,Experience- Minimum 4 years in RAJob Profile-•CTD or ACTD dossier preparation for ROW...

1. Preparation, Review and Submission of the Dossiers as per CTD/ACTD guidelines as well a country specific guidelines. 2. Compilation of Dossiers and quality documents as per checklist in the guidelines. 3. Review of artworks as per the Regulatory requirements 4. Inter Department coordination to arrange and review of documents and samples for Regulatory...

**Responsibilities** - Review formulations and claims and provide regulatory guidance to ensure full compliance to regulations including mandatory standards. - Oversight of the preparation and filing of regulatory documents with the FDA and international regulatory bodies; setting the standards for and reviewing all submissions to assure adequacy and...

**Description**: - They must have excellent organizational, analytical, project management, and communication skills. - They work frequently with other employees and team members to coordinate complex activities, often with competing priorities. - Most regulatory affairs positions are full time. - Regulatory Responsibility means a duty or responsibility,...