Confidential jobs - Regulatory Affairs Specialist - Jr Manager

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