Regulatory Affairs Executive

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 -...

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....

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...

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 - 2-4 year's minimum in regulatory affairs Job profile: 1....

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...

**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...

**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,...

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...

**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...

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...

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...

Job Description: Job responsibilities:Preparation, Compilation and review of registration dossier of tablet /capsule/injection in CTD,ACTD as well as country specific format for countriesPreparation, Compilation and review of registration dossier of capsule/syrup/balm in a Herbalproducts for country specific format in countries of African...

Job Description: Job responsibilities: Preparation, Compilation and review of registration dossier of tablet /capsule/injection in CTD, ACTD as well as country specific format for countries Preparation, Compilation and review of registration dossier of capsule/syrup/balm in a Herbal products for country specific format in countries of African...

Duties and Responsibilities: - 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...

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 -...

**Job Description Description**: **Qualification: B.Pharma - Pharmacy; M.Pharma - Pharmacy** **Tablet and capsule** - Hand on experience in preparation of CTD section as per regulatory requirements of different region - Having experience in preparation of query response and PAS, CBE and annual report. - Have ability to co-ordinate with cross functional...

**Job Types**: Full-time, Regular / Permanent **Salary**: ₹500,000.00 - ₹600,000.00 per year **Benefits**: - Health insurance - Leave encashment - Life insurance - Paid sick time - Paid time off - Provident Fund Schedule: - Day shift - Morning shift Supplemental pay types: - Yearly bonus Ability to commute/relocate: - Vadodara, Gujarat: Reliably...

Preparation and submission of Dossier for Tablets, Capsules, Liquid Injection in CTD, ACTD, and Country Specific formats for ROW Market. - Review and successfully responding queries received from Regulatory Authorities of Respective Countries. - Review of Supporting Documents for Marketing Authorization Application Like Finish Product Specification, Method...

JOB ID: 240204 Job family Regulatory Job Type Full Time Location Vadodara, Gujarat Nature of Work On-site Company Name JC OrthoHeal Private Limited **Summary**: Executive (QA, RA) (Level I/ II) will work with the regulatory team and formulate or implement regulatory affairs policies and procedures. **Key Roles and **Responsibility** - Formulate or...