Job Description

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 - 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 - 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 "Rapid Response Teams" 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\xe2\x80\xa2 3-5 years of relevant work experience in the pharmaceutical industry with experience working with product life cycle management

• Bachelor\'s 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

eQuest