JOB PURPOSES:
● Visionary: Understand the company’s vision and translate it into clear prioritized outcomes for patients.
● Architect: Self-organize, priority, make great “game time” decision. Balance between tactics to achieve short-term outcomes and focus what needed to have an exponential impact achieving faster and better outcomes.
● Coach: Coach new members, peers & being coached. Build the skills and mindsets needed to take accountability to achieve exceptional outcomes.
● Catalyst: Understand the Technical Regulatory pain-points & address the needs. Foster connections across Vietnam and the Global network.
MAIN RESPONSIBILITIES
Overall
● Carry our all regulatory affairs responsibilities and activities for assigned products at local affiliate with high compliance standard.
● Collaborate with both internal cross-functional team members, as well as with external stakeholders to achieve objectives.
● Understand company’s vision & shared goals in Vietnam and translate it into clear prioritized objectives for regulatory.
Strategy/ Planning
● Plan and implement registration strategies to assure business continuity and support business
● Gather, analyze and communicate internal and external regulatory intelligence
● Develop innovative, risk-based registration plans and submissions strategies for responsible products with guidance from RA Director
● Embed themselves in Integrated Disease Teams and represent regulatory function on providing regulatory expertise and input in cross-functional meetings to co-create ways to achieve rapid and continued access to medicines.
Filings
● Execute and manage of all regulatory filling activities (incl., Brand name or reference biotech products) across product lifecycle. It includes the new registration/ extension/ TRIC/ CDS update/label update or any other variations/ corrections.
● Initiate regulatory fillings aligned with business and supply needs to assure business continuity.
● Monitor and communicate all regulatory fillings status and respond to internal and external questions.
● Ensure timely regulatory fillings submissions and approvals.
● Influence internal and external stakeholders for successful regulatory outcomes.
● SIQ if needed
Information and Documentation Management
● Manage Affiliate regulatory activities on relevant systems:
○ Global: GPRS, interface portal, Q&A interface portal, CPP system, COREMAP, etc.
○ Local: Touchpoint, Google Share Drive, Report, etc.
● Manage product information updates with respect to company and local regulatory requirements and for company’s databases
● Ensure up-to-date and accurate information in all related systems, reports.
Regulatory Compliance
● Develop and maintain current knowledge of international requirements and local regulations.
● Ensure regulatory inspection-readiness for the Affiliate, as per assigned responsibilities
● Ensure regulatory compliance for product released to market according to marketing authorizations
● Control, manage and develop the regulatory data with timely updates for additional/ changes (e.g Record Decision, MA, approved PIs & artworks; approved indications… CPP, GMP, trade mark certificate, power of attorney, plant master files of manufacturing for assigned products)
Co-ordination
● Co-ordinate with labelling responsible to ensure local product packaging and labelling in line with local regulations related regulations such as 4-eyes checking,…
● Where applicable, review and approve promotional materials to provide regulatory input and guidance across the Affiliate
● Technical quality: Support Quality person to implement local quality SOP (if any)
● Support business from regulatory perspective such as tender documents, SIQ…
● Co-ordinate with supply chain to minimize stock out due to regulatory activities.
Decision-making authority
● Routine activities for assigned products
● Empowered to make decision in cross-functional meetings
● Decisions made in consultation:
○ RA plan/ strategy
○ RA filling/de-registration/ life product cycle plan
○ Timing
○ Process change
Essential Accountabilities
● Ensure that all in-field activities are in line with relevant Vietnamese regulations, the IFPMA, local pharma code and business principles and values
● Be accountable for compliance to business ethics and regulations
● Be responsible for all aspects of safety, health and environmental protection in the areas under control
● Be responsible for reporting all available information of an adverse event within one business day of awareness
Others
● Any other duties that may be assigned from time to time as required by the business.
● Ready to back up for other regulatory roles