Executive - Regulatory Affairs

4 hours ago

Vadodara Gujarat, India Sun Pharmaceutical Industries Full time

Job Title Executive - Regulatory Affairs Business Unit R D1 Regulatory Affairs Job Grade G12A Location Baroda At Sun Pharma we commit to helping you Create your own sunshine - by fostering an environment where you grow at every step take charge of your journey and thrive in a supportive community Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world you ll find yourself becoming Better every day through continuous progress Exhibit self-drive as you Take charge and lead with confidence Additionally demonstrate a collaborative spirit knowing that we Thrive together and support each other s journeys Regulatory submission of new products renewals variations response to queries and Life cycle management for MENA markets through preparation of quality dossiers enabling timely approvals Area of Responsibility 1 New submissions Renewals a Review prepare CMC Chemistry Manufacturing and Controls dossiers for fresh submissions b Review documents Development report scale up report specification stability protocol artworks etc before initiation of Exhibit batches for adequacy 2 Approval Review prepare response to deficiency enabling approval of products filed to regulatory agency 3 Lifecycle management for drug formulations a Prepare and review variations as per the country specific requirements to support approval of changes such as API vendor changes changes in ROS test parameters DF site changes harmonization of products etc 4 Regulatory compliance a Prepare Review and circulate approval package with product history sheet to stake holders upon receipt of approval and updatethe same based on queries and variations b Ensure reposition of comprehensive product information into central repository C Review regulatory filing impact of variations change controls etc 5 Geographic Scope Market MENA-GCC UAE Oman Saudi Arabia Egypt Iran Iraq Bahrain etc Travel Estimate NA Job Requirements Educational Qualification Graduate M Sc M Pharm Experience Tenure 1-4 years Your Success Matters to Us At Sun Pharma your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth Join us at Sun Pharma where every day is an opportunity to grow collaborate and make a lasting impact Let s create a brighter future together Disclaimer The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification It is not designed to contain or be interpreted as a comprehensive inventory of all duties responsibilities and qualifications required of employees as assigned to this job Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent s

  • Regulatory Affairs Executive

    1 week ago

    Vadodara, India Amico Formulations LLP Full time

    **Post**: RA Executive **Experience**: 5+ Years Experience in Regulatory Affairs in Pharma Industry (Formulation) **Location**: Vadodara - 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...

  • Executive - Regulatory Affairs

    1 week ago

    Tandalja, Vadodara, Gujarat, India Sun Pharmaceutical Industries Ltd Full time

    **Title**:Executive - Regulatory Affairs**: - Date: Jul 4, 2025 - Location: Tandalja - R&D - Company: Sun Pharmaceutical Industries Ltd - Preparation, reviewing, timely submission and coordination of implementation of labeling based on FDA notifications and/or RLD labeling updates. - Coordination of labeling related activities with cross functional teams...

  • Executive - Regulatory Affairs

    1 week ago

    Tandalja, Vadodara, Gujarat, India Sun Pharmaceutical Industries Ltd Full time

    **Title**:Executive - Regulatory Affairs**: - Date: Sep 26, 2025 - Location: Tandalja - R&D - Company: Sun Pharmaceutical Industries Ltd **Job Title**: Executive - Regulatory Affairs **Business Unit**: R&D1 Regulatory Affairs **Job Grade** G12A **Location** Baroda At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering...

  • Regulatory Affairs Executive

    1 day ago

    Vadodara, India Vega Biotec Pvt. Ltd Full time

    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...

  • Regulatory Affairs Executive

    1 day ago

    Navrangpura, Ahmedabad, Gujarat, India Bexcode Services Full time

    **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. -...

  • Regulatory Affairs Executive

    4 days ago

    Vadodara, Gujarat, India Ami Lifesciences Full time

    **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

    6 days ago

    Vadodara, Gujarat, India Sai Placement Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    URGENT OPENING FOR REGULATORY AFFAIRS OFFICER/ SR OFFICER LOCATION VADODARA Position:-Regulatory Affairs Officer/ Sr OfficerLocation:-VadodaraExperience:-1 to 3 Yrs (Formulation)Qualification :- B.Pharm/ M.Pharm Required Candidate profilePreparing dossiers as per country-specific guidelines.Compiling and reviewing documents.Coordinating with QA for...

  • Regulatory Affairs Executive

    1 day ago

    Ellora Park, Vadodara, Gujarat, India Samarthhrconsultant Full time

    Regulatory affairs 4+ years of experience agrochemical/pesticide. Experience with regulatory submissions, dossier preparation, and interactions with regulatory authorities. Ellora park vadodara Pay: From ₹12,000.00 per month **Experience**: - total work: 1 year (preferred) Work Location: In person Application Deadline: 30/01/2025 Expected Start...

  • Regulatory Affairs Executive

    24 hours ago

    Vadodara, Gujarat, India Amico Formulations LLP Full time ₹ 2,50,000 - ₹ 3,00,000 per year

    POST: RA OFFICER/EXECUITVELOCATION: JAROD, VADODARAEXPERIENCE: 2-3 YEARSExperience in handling regulatory affairs for ROW market mainly 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,...

  • Regulatory Affairs Executive

    1 week ago

    Vadodara, India RG HR Solutions Full time

    Studying scientific and legal documents - Gathering, evaluating, organising, managing and collating information in a variety of formats - Ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA) - Maintaining familiarity with company product ranges - Planning, undertaking and overseeing product trials and...