YOUR TASKS AND RESPONSIBILITIES:
• Liaise with Country Head of RA CH, regional RA APAC team and other stakeholders to
a. Develop registration strategy and milestone plan for new drugs in line with local business priorities and export business.
b. Manage the compilation and submission of applications for product registration and maintenance of licenses.
...
c. Provide regulatory input in order to obtain timely regulatory approvals for the products by coordinating with other relevant functions.
• Responsible for managing the regulatory activities for imported products and overseeing product registration for Exports to support local business priorities and export business.
• Work closely with local PS, Supply Chain management and Quality organization to ensure regulatory compliance of locally manufactured products, to ensure required licenses for proper product distribution are in place, including artwork maintenance, regulatory input into issue management.
• Responsible for managing Manufacturing License applications/renewals, Artwork preparations & management, support to tender business by procuring relevant certificates.
• Responsible for Regulatory compliance, including :
a. Prepare RA reports and ensure global and local registration databases are updated timely and in accordance with applicable local/global guidance documents
b. Provide RA division support to plan and prepare for inspection by health authorities and internal audits.
c. Support internal partners by giving regulatory input / recommendation to ensure that companies comply with current applicable regulatory affairs laws and regulations.
d. Regulatory quality management: Responsible for local and internal compliance to regulatory affairs relevant processes and systems.
e. Ensure regulatory compliance for a sustainable life-cycle management: Labeling, CMC changes and product lifecycle support are performed in accordance with local regulations and relevant SOPsf. Ensure mandatory compendial /Pharmacopoeia compliance of input materials and finished products. Obtain revised product permission from State Drug Authorities / Central Drug authority in case of compendial / Pharmacopoeial amendments of finished product label claim.
• To work on application files for products based on the documentation provided from local/regional/global RA and other cross-functional partners in accordance with local regulations, of acceptable standard and quality to present them to the Health Authority. Experience Required: • Post graduate (preferably Pharmacy) with at least 8 years of regulatory experience. PhD is preferred.
• The experience must include at least a few years of operational experience in handling regulatory activities for locally manufactured products, imported products and export to neighboring countries.
• Exposure of formulation and development and/or quality assurance activities highly desired.
• In depth understanding of CMC, non-clinical and clinical data aspects for regulatory submission.
experience
12show more YOUR TASKS AND RESPONSIBILITIES:
• Liaise with Country Head of RA CH, regional RA APAC team and other stakeholders to
a. Develop registration strategy and milestone plan for new drugs in line with local business priorities and export business.
b. Manage the compilation and submission of applications for product registration and maintenance of licenses.
c. Provide regulatory input in order to obtain timely regulatory approvals for the products by coordinating with other relevant functions.
• Responsible for managing the regulatory activities for imported products and overseeing product registration for Exports to support local business priorities and export business.
• Work closely with local PS, Supply Chain management and Quality organization to ensure regulatory compliance of locally manufactured products, to ensure required licenses for proper product distribution are in place, including artwork maintenance, regulatory input into issue management.
• Responsible for managing Manufacturing License applications/renewals, Artwork preparations & management, support to tender business by procuring relevant certificates. ...
• Responsible for Regulatory compliance, including :
a. Prepare RA reports and ensure global and local registration databases are updated timely and in accordance with applicable local/global guidance documents
b. Provide RA division support to plan and prepare for inspection by health authorities and internal audits.
c. Support internal partners by giving regulatory input / recommendation to ensure that companies comply with current applicable regulatory affairs laws and regulations.
d. Regulatory quality management: Responsible for local and internal compliance to regulatory affairs relevant processes and systems.
e. Ensure regulatory compliance for a sustainable life-cycle management: Labeling, CMC changes and product lifecycle support are performed in accordance with local regulations and relevant SOPsf. Ensure mandatory compendial /Pharmacopoeia compliance of input materials and finished products. Obtain revised product permission from State Drug Authorities / Central Drug authority in case of compendial / Pharmacopoeial amendments of finished product label claim.
• To work on application files for products based on the documentation provided from local/regional/global RA and other cross-functional partners in accordance with local regulations, of acceptable standard and quality to present them to the Health Authority. Experience Required: • Post graduate (preferably Pharmacy) with at least 8 years of regulatory experience. PhD is preferred.
• The experience must include at least a few years of operational experience in handling regulatory activities for locally manufactured products, imported products and export to neighboring countries.
• Exposure of formulation and development and/or quality assurance activities highly desired.
• In depth understanding of CMC, non-clinical and clinical data aspects for regulatory submission.
experience
12show more
