Primary Function:
• Be accountable for developing regulatory strategy for the responsible projects with the guidance of senior regulatory manager
• Be accountable for the regulatory strategy implementation by CTA/NDA submission/approval
• Be accountable for HA interaction for regulatory strategy assessment with the guidance of senior regulatory manager
• Support line manager for regulatory intelligence collection and analysis
• Support line manager on integration for regulatory strategy assessment
Major Responsibilities and Duties:
1. Responsibilities
· Adherence to Zailab and industry code of conduct, ethics and good regulatory practices including RA SOPs and other required SOPs.
1）Align with the values and vision of Zailab
2）Maintain regulatory compliance (PI & CMC) with Local legislation, Global regulatory policies, Zailab code of conduct
3）Maintain company confidentiality (i.e. intellectual property, product information and strategic information)
4）Disclose potential breach of codes or conduct
5）Follow SOP requirements especially on documentation
· For allocated portfolio develop and action regulatory strategies to achieve rapid and high-quality approval and facilitate rapid launch.
1）Maintain detailed knowledge of critical aspects of products: commercial strategies, content of the dossiers, regulatory intelligence, regulatory timeline, supply strategy
2）Assist in ensuring local regulatory strategies are consistent with global product strategies and local priorities
3）Develop regulatory plan in conjunction with key stakeholders, ensure allocation of adequate resources and deliver plans on time
4）Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch
· Maintain product licenses in assigned portfolio through timely renewal to a high standard.
1）Monitor status of product licenses
2）Project manage changes in product licenses and coordinate with other changes, planned and in progress
3）Maintain complete documentation records
4）Communicate changes to license status promptly
· Maintain the awareness and shape the regulatory environment relevant to the assigned portfolio.
1) Monitor and understand the impact of external changes in the regulatory and political environment that will impact on the assigned products
2) Communicate the impact of changes to key stakeholders.
3) Influence key external stakeholders, in line with codes of conduct, to improve regulatory outcomes
· Actively develop excellent relationship with local regulatory authorities and external stakeholders.
1) Build up Zailab’s good image through high professional standard of application, response to enquiries etc.
2) Establish good relationships with regulatory authorities through regular contacts and sponsorship for academic initiatives or trainings
· Drive issue Management.
1) Provide detailed analysis on regulatory status of affected products
2) Develop and undertake assigned follow-up action where necessary
2. Marketing Support
· Attend Regulatory Affairs, Clinical Operation & Regulatory and other internal meetings as required
3. Teamwork Spirit
· Actively participate in team working
· Share best practice examples & learning with the team and regional/global colleagues
4. Personal Development
· Attend and actively participate in personal development courses as required
· Participate in Regulatory Affairs and Clinical Operation & Regulatory related workshops
