Job Description
Send me Jobs like this | Save this Job | Report this JobI. Regulatory Submissions and Approvals
a) Dossier Preparation - Prepare, review quality regulatory dossier and prepare a compliance report of dossier evaluation with reference to the country regulations. To work within the regulatory timelines for dossier submission.
b) Provide the necessary support function:
1. Maintenance of the Product Dossiers, data files, etc.
2. Communication/Coordination with local affiliate members .
II. Regulatory Compliance (Quality Control/Quality Assurance)
a) Compliance Maintenance Provide support to maintain all local marketed products in compliance with local and corporate regulatory requirements.
b) Handling of complaints and Pharmacovigilance activities in the affiliate market for the products: Evaluation, monitoring and reporting via specific system, build better customer platform to bring in Product/ service value addition while working with Affiliate team members.
c) Compliance review for the Labeling and Promotional materials etc.
c) Good Regulatory Practices (GRP) - Prepare and review necessary standards (SOP's, Procedures etc) to facilitate the Regulatory functions, thereby implementing Global Regulatory Affairs policies (Regulatory Quality Systems), local regulations and acceptable Good Regulatory Practices.
d) Support the RA manager for implementation of the quality system standards in the affiliate market maintaining the necessary documentation, licenses etc. including training.
II. Regulatory Influence
External
a) Regulatory Environment Changes Support the RA Manager to keep updated with current local regulations and DRA organizational structure and potential changes that will impact the business environment, and communicate appropriately to involved or affected parties.
Internal
a) Affiliate Organization
Learn and understand the local affiliate organization and functions.
Provide support function to build functional partnership and credibility to maximize regulatory value
Educate the affiliate the value that the regulatory function can significantly contribute to the business.
Additional Responsibility (if applicable)
a) Provide necessary regulatory support for locally performed clinical trials/GCT (i.e. Prepare and review report on the
a) Dossier Preparation - Prepare, review quality regulatory dossier and prepare a compliance report of dossier evaluation with reference to the country regulations. To work within the regulatory timelines for dossier submission.
b) Provide the necessary support function:
1. Maintenance of the Product Dossiers, data files, etc.
2. Communication/Coordination with local affiliate members .
II. Regulatory Compliance (Quality Control/Quality Assurance)
a) Compliance Maintenance Provide support to maintain all local marketed products in compliance with local and corporate regulatory requirements.
b) Handling of complaints and Pharmacovigilance activities in the affiliate market for the products: Evaluation, monitoring and reporting via specific system, build better customer platform to bring in Product/ service value addition while working with Affiliate team members.
c) Compliance review for the Labeling and Promotional materials etc.
c) Good Regulatory Practices (GRP) - Prepare and review necessary standards (SOP's, Procedures etc) to facilitate the Regulatory functions, thereby implementing Global Regulatory Affairs policies (Regulatory Quality Systems), local regulations and acceptable Good Regulatory Practices.
d) Support the RA manager for implementation of the quality system standards in the affiliate market maintaining the necessary documentation, licenses etc. including training.
II. Regulatory Influence
External
a) Regulatory Environment Changes Support the RA Manager to keep updated with current local regulations and DRA organizational structure and potential changes that will impact the business environment, and communicate appropriately to involved or affected parties.
Internal
a) Affiliate Organization
Learn and understand the local affiliate organization and functions.
Provide support function to build functional partnership and credibility to maximize regulatory value
Educate the affiliate the value that the regulatory function can significantly contribute to the business.
Additional Responsibility (if applicable)
a) Provide necessary regulatory support for locally performed clinical trials/GCT (i.e. Prepare and review report on the
clinical Trial dossier for submission; CT material labeling, other licenses, etc)
Salary:
INR 50,000 - 3,00,000 P.A
Industry:
Pharma / Biotech / Clinical Research
Functional Area:
Other
Role Category:
Other
Role:
Other
Keyskills:
Regulatory Quality Assurance / Testing
Desired Candidate Profile
Education:
Please refer to the Job description aboveUG - B.Sc - Any Specialization, B.Pharma - Pharmacy
PG - M.Sc - Any Specialization, M.Pharma - Pharmacy
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
PG - M.Sc - Any Specialization, M.Pharma - Pharmacy
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Company Profile
New Era India Consultancy Pvt. Ltd.
Leading Pharma MNCContact Details
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