Job Designation - Senior Manager (Internationalegu Rlatory Affairs)
Job Description
1.Supporting the dossier Preparation & Submission activity as per company timelines.
2.Ensuring regulatory adequacy and accuracy of all the data required for dossier submission for respective country.
3.Handling of queries from external agencies. Supporting the regulatory compliance activity in the plant. Training and development of support staff.
4.Coordinating with various internal and external departments for regulatory activity.
Requirements
1.Knowledge of regulatory and GMP guidelines for API and formulations manufacturing.
2.Acquittance to QA/QC documentation. Understanding of analytical methods.
3.Experience of technology transfer requirements.
4.Awareness to different aspects of Packaging
5.Ability to interpret and communicate the legal and regulatory documents.
6.Knowledge of pharmacology.
7.Scientific Project Management
Education -UG/PG in Pharmacy with 6-8 experience.
Contact
Mr.Nitendra Patel
Cadila Healthcare Limited
Zydus Tower
Satellite Cross Road,
Ahmedabad,gujarat,
Phone 91-02717-666200
www.zyduscadila.com
Job Description
1.Supporting the dossier Preparation & Submission activity as per company timelines.
2.Ensuring regulatory adequacy and accuracy of all the data required for dossier submission for respective country.
3.Handling of queries from external agencies. Supporting the regulatory compliance activity in the plant. Training and development of support staff.
4.Coordinating with various internal and external departments for regulatory activity.
Requirements
1.Knowledge of regulatory and GMP guidelines for API and formulations manufacturing.
2.Acquittance to QA/QC documentation. Understanding of analytical methods.
3.Experience of technology transfer requirements.
4.Awareness to different aspects of Packaging
5.Ability to interpret and communicate the legal and regulatory documents.
6.Knowledge of pharmacology.
7.Scientific Project Management
Education -UG/PG in Pharmacy with 6-8 experience.
Contact
Mr.Nitendra Patel
Cadila Healthcare Limited
Zydus Tower
Satellite Cross Road,
Ahmedabad,gujarat,
Phone 91-02717-666200
www.zyduscadila.com
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