Manager - Regulatory Affairs
Manager - Regulatory Affairs
Posted on :
04-12-2024
Employer Active
1 Vacancy
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Job Description
Permissions and Procedures:
A. DCGI (Delhi)
i. Ensure dossier compilation and submission of NDA (As per NDCT Rules) and registration certificate via form 40 including renewal agreement.
ii. Responsible for application of test license and import license along with necessary renewal processes if any.
iii. Coordinate with regulatory for clinical trials (if any) Protocol & CRF design
iv. Facilitate the process of analytical testing leading to the timely clearance of goods imported.
B. State FDA
i. Facilitate local manufacturers in obtaining manufacturing licenses and liaison with concerned key officials.
ii. Provide necessary clinical and technical documentation to local manufacturers.
iii. Effectively liaise between local manufacturer and corporate regulatory and MTO Departments.
Quality Management: Perform quality and compliance specific tasks including but not limited to processing product complaints review of information about secondary packaging/redressing ensure proper labelling of products at the distributor and product recall coordination.
Compliance for Companys Global units: Meet and ensure necessary ethical moral and legal requirements in the areas of medico marketing clinical trials and CRM activities.
Import related activities: Facilitate the process of product imports by handling queries with related customs officials and analytical testing leading to the timely clearance of goods imported.
Export related activities: Compile submit and coordinate for relevant data required for achieving company & product registrations in other countries in a timely manner like Sri Lanka/ Pakistan/ Bangladesh/ Nepal/ Maldives.
Packaging & Promotional Literature: Review all packaging artworks and promotional literature from a regulatory perspective as per internal and corporate SOPs in place for all products of the company.
A. DCGI (Delhi)
i. Ensure dossier compilation and submission of NDA (As per NDCT Rules) and registration certificate via form 40 including renewal agreement.
ii. Responsible for application of test license and import license along with necessary renewal processes if any.
iii. Coordinate with regulatory for clinical trials (if any) Protocol & CRF design
iv. Facilitate the process of analytical testing leading to the timely clearance of goods imported.
B. State FDA
i. Facilitate local manufacturers in obtaining manufacturing licenses and liaison with concerned key officials.
ii. Provide necessary clinical and technical documentation to local manufacturers.
iii. Effectively liaise between local manufacturer and corporate regulatory and MTO Departments.
iv. Facilitate design of draft labels.
Quality Management: Perform quality and compliance specific tasks including but not limited to processing product complaints review of information about secondary packaging/redressing ensure proper labelling of products at the distributor and product recall coordination.
Compliance for Companys Global units: Meet and ensure necessary ethical moral and legal requirements in the areas of medico marketing clinical trials and CRM activities.
Import related activities: Facilitate the process of product imports by handling queries with related customs officials and analytical testing leading to the timely clearance of goods imported.
Export related activities: Compile submit and coordinate for relevant data required for achieving company & product registrations in other countries in a timely manner like Sri Lanka/ Pakistan/ Bangladesh/ Nepal/ Maldives.
Packaging & Promotional Literature: Review all packaging artworks and promotional literature from a regulatory perspective as per internal and corporate SOPs in place for all products of the company.
Employment Type
Full Time
Key Skills
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