Confidential jobs - Regulatory Affairs Specialist - Jr Manager

Regulatory Affairs Specialist - Jr Manager

Confidential
experience 2 to 3 Years
salary Salary not disclosed
qualification
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Posted: 2 Months ago
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Job Description

Jr. Manager - Regulatory Affairs

  1. Preparation, review, author dossiers/license applications for International markets (USA, EU, and Canada).
  2. Publishing dossier with eCTD software for USA, EU, and Canada markets.
  3. Preparation, review, submission of license documents to State DCA, CDSCO offices and preparation of domestic applications
  4. Active participation in the regulatory submission strategy designing.
  5. Coordinating effectively with all cross-functional teams (QC, QA, R&D, and Production) to procure the documents and to develop the documents required for the compilation of applications.
  6. Providing Gap analysis, ensuring the accuracy, completeness, quality of documents available, conversion of existing dossiers as per the market-specific requirements.
  7. Evaluation of changes during the post-submission period, submission of Notification, post-approval changes to the approved applications.
  8. Good knowledge of the D&C Act, 21 CFR, ICH, and other regulations.
  9. Provide guidance to manufacturing personnel about the latest regulatory requirements and cGMP requirements, fulfilling responsibilities of Regulatory personnel during inspections.
  10. Effectively liaising with State DCA, CDSCO office personnel’s and counterparties.


Requirements:

  1. At least 2 to 3 years experience in the Regulatory Affairs Department of any top pharmaceutical company.
  2. Registration experience in other markets like the US, EU, Canada markets will be an added advantage.
  3. Must be Proficient in written, verbal, Computer skills, and business communication.
  4. Should be self-motivated and result oriented.
  5. Ability to multitask and prioritize responsibilities.
  6. M. Sc or M. Pham

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Job Particulars

Job TypeApprenticeship
Hiring Process Face to Face Interview

About Company

Confidential
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experience 2 to 3 Years
locationHyderabad
salary Salary not disclosed
6 days ago
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Confidential recruiting Regulatory Affairs Specialist - Jr Manager Experienced(2 to 3 Years) candidates candidates nearby Hyderabad,.Confidential vacancies for Regulatory Affairs Specialist - Jr Manager is recruited through Written-test, Face to Face Interview etc.
Confidential Company recruits a lot of Experienced(2 to 3 Years) candidates candidates every year based on the skills . The candidates with M.Pham, MSc, Other Course are selected to full fill the vacancies in Management Trainee job field. The candidates nearby Hyderabad, can apply for Regulatory Affairs Specialist - Jr Manager position in Confidential. All candidates should have a degree or post-graduation in the required field based on the requirement mentioned. The jobs are available in Full Time basis. When it comes to the Confidential recruitment, candidates are mostly chosen for the department of Management Trainee . To learn more about the current jobs and other details, it is better to go through official site of Confidential and Teamlease.com. Find the latest jobs near you and near your home. So, that you don’t need to relocate. The Teamlease.com is a leading employment portal that researches the official site of Confidential and provides all the details about the current vacancies, the application process, selection process, interview test details, important dates and other information. Search and apply for the top job positions in Confidential and near your city and get a secured career.