Regulatory Affairs Manager - 12 months FTC
- Recruiter
- Kyowa Kirin International
- Location
- Marlow
- Salary
- Competitive
- Posted
- 30 Jul 2022
- Closes
- 26 Aug 2022
- Sectors
- Engineering, Defence
- Contract Type
- Permanent
- Hours
- Full Time
Job Purpose:
This role principally manages Kyowa Kirin regulatory aspects in the EMEA region to ensure that marketing authorisation of products is achieved in a timely manner and post-licensing regulatory activities associated with all Kyowa Kirin s global marketed products in the partner territories are in compliance with applicable legislation and business requirements. This position supports company vision for the EMEA global geographic expansion.
The role:
Compliance with relevant regulatory legislation and guidelines and internal procedures in relation to gaining and maintaining marketing authorisations.
Defining project and product regulatory strategy in line with Kyowa Kirin s International Expansion and Partnership Management strategy;
Representation of regulatory affairs in partner and cross-functional team meetings for defined projects, providing information, feedback, and strategic advice.
Management of the regulatory activities associated with partnership management plans.
Production of all types of regulatory submissions as needed to support the Kyowa Kirin business in the specified territories.
Maintenance of regulatory approvals including follow-up of commitments as a condition of approval, and post-approval submissions.
Tracking of partner data requests and regulatory submissions, including post approval commitments/measures and other obligations.
Management of regulatory product information.
Regulatory activities are carried out in compliance with regulatory standards and company standards, such as Standard Operating Procedures (SOPs).
Support the continuous improvement of regulatory and cross-functional processes.
Support the selection of junior regulatory staff, their development and training.
Qualifications:
Life science qualification with broad experience in the pharmaceutical industry, and specifically in EMEA and LATAM regulatory affairs.
Expert technical knowledge, particularly of module 3 of the Common Technical Document.
Expert regulatory knowledge of European and overseas markets, particularly Middle East, Africa and LATAM
This role principally manages Kyowa Kirin regulatory aspects in the EMEA region to ensure that marketing authorisation of products is achieved in a timely manner and post-licensing regulatory activities associated with all Kyowa Kirin s global marketed products in the partner territories are in compliance with applicable legislation and business requirements. This position supports company vision for the EMEA global geographic expansion.
The role:
Compliance with relevant regulatory legislation and guidelines and internal procedures in relation to gaining and maintaining marketing authorisations.
Defining project and product regulatory strategy in line with Kyowa Kirin s International Expansion and Partnership Management strategy;
Representation of regulatory affairs in partner and cross-functional team meetings for defined projects, providing information, feedback, and strategic advice.
Management of the regulatory activities associated with partnership management plans.
Production of all types of regulatory submissions as needed to support the Kyowa Kirin business in the specified territories.
Maintenance of regulatory approvals including follow-up of commitments as a condition of approval, and post-approval submissions.
Tracking of partner data requests and regulatory submissions, including post approval commitments/measures and other obligations.
Management of regulatory product information.
Regulatory activities are carried out in compliance with regulatory standards and company standards, such as Standard Operating Procedures (SOPs).
Support the continuous improvement of regulatory and cross-functional processes.
Support the selection of junior regulatory staff, their development and training.
Qualifications:
Life science qualification with broad experience in the pharmaceutical industry, and specifically in EMEA and LATAM regulatory affairs.
Expert technical knowledge, particularly of module 3 of the Common Technical Document.
Expert regulatory knowledge of European and overseas markets, particularly Middle East, Africa and LATAM