Regulatory Affairs Specialist - Jr Manager Jobs in Hyderabad - Confidential
Job Description
Jr. Manager - Regulatory Affairs
- Preparation, review, author dossiers/license applications for International markets (USA, EU, and Canada).
- Publishing dossier with eCTD software for USA, EU, and Canada markets.
- Preparation, review, submission of license documents to State DCA, CDSCO offices and preparation of domestic applications
- Active participation in the regulatory submission strategy designing.
- 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.
- Providing Gap analysis, ensuring the accuracy, completeness, quality of documents available, conversion of existing dossiers as per the market-specific requirements.
- Evaluation of changes during the post-submission period, submission of Notification, post-approval changes to the approved applications.
- Good knowledge of the D&C Act, 21 CFR, ICH, and other regulations.
- Provide guidance to manufacturing personnel about the latest regulatory requirements and cGMP requirements, fulfilling responsibilities of Regulatory personnel during inspections.
- Effectively liaising with State DCA, CDSCO office personnelâs and counterparties.
Requirements:
- At least 2 to 3 years experience in the Regulatory Affairs Department of any top pharmaceutical company.
- Registration experience in other markets like the US, EU, Canada markets will be an added advantage.
- Must be Proficient in written, verbal, Computer skills, and business communication.
- Should be self-motivated and result oriented.
- Ability to multitask and prioritize responsibilities.
- M. Sc or M. Pham
Job Particulars
Role management trainee
Who can apply Experienced (2 to 3 Years)
Hiring Process Face to Face Interview
Employment Type0
Job Id1061864
Job Category BSc/BCA/BBM , Management
Locality Address
State Telangana
Country India
About Company
Confidential
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