The RMC Liaison is a member of the Regulatory Management Centre (RMC) and is responsible for management of regulatory life cycle management activities in Asia Pacific (AP) for their assigned therapeutic area/s. The RMC Liaison is responsible for supporting the RMC Submission Professionals in the LOCs in AP. The role also includes working as the AP Regulatory Lead for assigned products in the Established Products portfolio. RESPONSIBILITIES \xe2\x80\x93 RMC LIAISON:
Manage RMC Submissions for assigned therapeutic area/s
Receive dossier/project from RMC Planning and Operations Lead
Support RMC submissions for other therapeutic area/s as and when required
Review dossiers received from global and evaluate countries impacted for changes.
Responsible for creation and maintenance of the country plan in the planning tool
Creation and maintenance of project entries in RMC tracker (excel spreadsheet)
Assess dossier for potential issues and proactively raise issues with global and discuss with APRA Lead
Collaborate with RMC Professionals and dossier leads on dossiers in scope, in case of priority changes or potential compliance risks
Collaborate with RMC LOC Submission Professionals to ensure submission deadlines for assigned therapeutic area/s are met for AP countries
Maintain a copy of the core dossier sent by global on REGAP
Train RMC Submission Professionals in LOCs as required
Facilitate discussion with the LOC on CMC variation / label change from global dispatch to local submission
Connect with Global, Regional and RMC LOC Submission Specialists on local dossier requirements
Prepare submission plan based on global dispatch and country specific requirements
Work closely with RMC LOC Submission Specialists to ensure country specific inputs are updated into the recipe book
Request country specific documents such as data administration, translation, artwork, samples and certificate
Responsible for training RMC LOC Submission Specialists when required
Close collaboration with RMC LOC Submission Specialists to maintain adherence to RMC processes
Responsible for notifying Compliance Manager when AP reference country approval is received
Connect with Regional Labelling Manager, LOC on content deviation process
Co-ordinate labelling deviations for assigned therapeutic area/s and where applicable through AP Labeling Manager
Collaborate with Compliance Manager to manage approval notifications from RMC LOC contacts
Qc and review of final dossier received from RMC LOC Submission Professionals prior to publishing
Work with RMC Planning and Operations Lead on post-approval activities
Co-ordination of updates to working guidelines for sections pertaining to roles of liaison
Close collaboration with RMC LOC Submission Specialists to maintain adherence to RMC processes
Co-ordinate deviation where applicable through labeling manager
Co-ordination of updates to working guidelines for sections pertaining to roles of liaison
RESPONSIBILITIES \xe2\x80\x93 AP REGULATORY LEAD (Established Products): Provides direction for the activities related with assigned products in the Established Products Portfolio. Works with regional management, head office-based team members (e.g. Strategic Implementation Leader) and local operating companies to define and implement the regional and local strategy for assigned products. Is accountable for the development of the regional regulatory strategy and ensures the implementation of multi-national /regional regulatory and strategies that optimize registration, and lifecycle management of marketed products, taking into consideration current and proposed changes in regulatory requirements and standards. Regulatory Strategy and Expertise
Understands regional and local requirements and advises the Global Regulatory Team (GRT) and Compound Development Team (CDT) on applicable regulatory requirements, guidelines and processes, region-specific regulatory issues with impact on the product strategy or deliverables. Keeps up-to-date on understanding of regional/regulatory environment.
Participates as a standing member of the project related GRT if applicable; supports the GRT by providing strategic regional input into registration and life cycle management.
Provides input in post-registration activities, including labeling changes
Provide regional implementation and regulatory-based advice on new and updated Core Data Sheets.
Maintains expert knowledge in regional regulatory requirements and ensure that staff is expert in country and product-specific regulatory requirements
Health Authority, Operating Companies, and Business Partner Interactions
Manages regulatory interactions with local operating companies and regional functions
Serves as point of contact with local operating companies
Interacts with local operating companies on individual products/processes
Facilitates discussions with local operating companies on regional or global regulatory issues, as required
Ensures excellent collaborative relationship with key stakeholders including staff in the region and global R&D partners.
Provides guidance to local operating companies to determine timing and strategy for regional HA meetings. Participates in preparations for interactions with HAs and assist operating company with these interactions.
Under the supervision and supported by a supervisor, provides guidance to local affiliates on development of strategies to accelerate submissions/approvals
Regulatory Submissions
Provides input to submission tactical planning and timelines including lifecycle submissions (labeling changes, renewals and safety reports).
Ensures maintenance of generic content plans for submissions in the region, including clinical trials and registration submissions
Coordinates and follows-up on post-approval submissions to ensure that product remains in compliance
Reviews and provides input to critical submission documents
Delivers on business critical regulatory submissions in accordance with development and/or post marketing priorities and timelines
Participates in \xe2\x80\x9cRapid Response Teams\xe2\x80\x9d to ensure appropriate and timely responses to HA questions. Provides clarification regarding HA questions and provides input to the strategy for responding to HA questions.
Ensures tracking of submission and approval milestones
Ensures tracking of regional post-approval commitments and ensures appropriate follow-up actions
Qualifications
3-5 years of relevant work experience in the pharmaceutical industry with experience working with product life cycle management
Bachelor\xe2\x80\x99s degree in Pharmacy
Solid and demonstrable understanding of Pharma regulations and the dynamics of regulatory environment in the region
Self-starter, able to work independently as well as in a small collaborative team
A problem-solver with good analytical skills and attention to detail
Demonstrable inter-personal skills and able to work with multiple stakeholders
Able to work across different cultures and generations
Driven, passionate and thrives in a fast-paced environment
Strong English communications skills both written and spoken as majority of stakeholders communicate via English
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