
Executive - Regulatory Affairs
2 days ago
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
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Regulatory Affairs Executive
2 weeks ago
Vadodara, Gujarat, India Ronak Group Full timeLooking 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 -...
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Regulatory Affairs Officer
1 week ago
Vadodara, Gujarat, India Vega Biotec Pvt. Ltd Full timeVega 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....
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Regulatory Affairs Executive
1 day 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...
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Regulatory Affairs Officer
6 days ago
Vadodara, India Vega Biotec Pvt. Ltd Full timeVega 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....
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Regulatory Affairs Executive
4 days ago
Bodakdev, Ahmedabad, Gujarat, India Sunchem Industrial Corporation Full timeRegulatory 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...
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Regulatory Affairs Executive
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Ahmadabad, Gujarat, India Aegis Lifesciences Pvt Ltd Full timeTitle/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...
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Regulatory Affairs Assistant
4 days ago
Vadodara, Gujarat, India Vega Biotec Pvt. Ltd Full timeVega 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...
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Executive Regulatory Affairs
1 week ago
Vadodara, Gujarat, India Exemed Full time ₹ 15,00,000 - ₹ 28,00,000 per yearResponsible for Regulatory Affairs functions at Exemed Pharmaceuticals Luna.Responsible for Issues Letter of Access, Letter of commitment and CEP certificate for customer as per specific regulatory requirement.To prepare commitment, Declaration and Statement certificate for customer as per specific regulatory requirement.Responsible for prepare and review...
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Executive - Regulatory Affairs
4 days ago
Vadodara, Gujarat, India SUN PHARMA Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob TitleExecutive – Regulatory AffairsBusiness UnitR&D1 Regulatory AffairsJob GradeG12ALocationBarodaAt 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...
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Regulatory Affairs Executive
1 day ago
Ahmedabad, Gujarat, India Sunrise Remedies Full timeSunrise 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...