Job Description

POSITION SUMMARY:

The Regulatory Management Centre (RMC) Liaison is a regional member of the RMC and is responsible for the regulatory management of lifecycle submissions and activities in Asia Pacific (AP) for their assigned therapeutic area/s and product portfolios. The RMC Liaison supports the RMC Submission Professionals based in the AP LOCs, who are responsible for the local execution of submissions. The role also has a dual responsibility to work as the AP Regulatory Lead (RL) for assigned products in the Established Products portfolio.

The position reports to the RMC Planning and Operations Lead.

RESPONSIBILITIES – RMC LIAISON:

• Manage RMC Submissions for assigned therapeutic area/s, and support RMC submissions for other therapeutic area/s as and when required
• Receive dossier/project from RMC Planning and Operations Lead
• Review core dossiers received from global and confirm impacted markets.
• Review core dossiers and identify and raise potential issues with global team and/or the AP RL
• Create and maintain each market’s submission plan in the RMC Tracker and planning tool
• Collaborate with and support RMC LOC Submission Professionals to ensure submission deadlines are met for AP markets
• Facilitate discussions between markets and global subject matter experts on activities associated with the local submission:
  • Support requests for additional local country-specific dossier requirements
  • Identify the need for local label deviations (LLDs) and co-ordinate LLD requests for submissions in RMC scope
  • Support Health Authority Queries (HAQs) for submissions in RMC scope
• In order to maintain the highest standards of compliance, collaborate closely with the RMC Systems Team, Compliance & Systems Manager, and RMC Submissions Team:
  • Ensure delayed submissions are valid and any request for extension is approved prior to the original submission due date
  • Ensure RMC LOC Submissions Professionals are adequately trained in RMC processes and adhere to these when working on in-scope submissions
• Assist with reference country monitoring processes across the region, specifically when an approval is received in an AP market and there is an AP-dependent market
• Contribute to the maintenance of the RMC Working Guidelines and identify when process updates or improvements are needed
• Act as regional point of contact for specific markets as RMC Partner, to triage and discuss process changes, local regulation updates and share feedback

RESPONSIBILITIES – AP REGULATORY LEAD (Established Products):

Provides regional regulatory support for activities related with assigned products in the EP Portfolio. Works with regional management, global team members (e.g. Strategic Implementation Leader) and LOC regulatory teams 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 GRT if applicable; supports the GRT by providing strategic regional input into registration and lifecycle management.
• Provides input to post-registration activities, including labeling changes.
• Provide regional implementation and regulatory-based advice on new and updated Company Core Data Sheets.
• Maintains expert knowledge in regional and product-specific regulatory requirements.
• Supports Health Authority, LOC, and Business Partner Interactions.
• Manages regulatory interactions with LOCs and regional functions.
• Facilitates discussions with LOCs 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 LOCs to determine timing and strategy for HA meetings. Participates in preparations for interactions with HAs and assists LOCs with these interactions.
• Under supervision and/or supported by a supervisor, provides guidance to LOCs 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, as needed.
• Ensures tracking of regional post-approval commitments and ensures appropriate follow-up actions.

Qualifications

Required

• University degree in pharmacy, life sciences or equivalent field
• 5 years or more relevant work experience in Regulatory Affairs/Government Affairs/Quality/Compliance/Manufacturing in medical or pharmaceutical companies
• Experience of working in a virtual team and/or global organization.
• Previous experience in RA role as Associate, Professional or similar role is of advantage.
• Knowledge of local regulations and international standards
• Able to make independent decisions
• Able to analyze complex information and situations and to formulate clear solutions
• Constructive team player
• Good communication and collaboration required

Desirable

• Project management: build and lead project teams, get things done, drive execution, collaborate in virtual teams
• Detail-orientation combined with being able to take a step back (helicopter view)
• Analytical skills and technical RA knowledge (ability to assess impact of CMC variation or label change on current situation)
• Ability to quickly acquire local knowledge and shift between local situations
• Communication skills and cultural sensitivity in working with stakeholders across countries
• Proficient in English (including technical RA English)
• Team player able to effectively collaborate with colleagues in virtual environment and able to do efficient handovers

LOCATION

• The position is located in the AP region.

TRAVEL REQUIRED

This role requires travel less than 10% of the time.

Primary Location
Singapore-Singapore-Singapore-
Other Locations
Asia Pacific-New Zealand, Asia Pacific-Taiwan, Asia Pacific-South Korea, Asia Pacific-China, Asia Pacific-Malaysia, Asia Pacific-Vietnam, Asia Pacific-China-Hong Kong S.A.R., Asia Pacific-Philippines, Asia Pacific-Japan, Asia Pacific-Australia, Asia Pacific-Indonesia, Asia Pacific-India, Asia Pacific-Thailand
Organization
Johnson & Johnson Pte. Ltd. (8435)
Job Function
Regulatory Affairs
Requisition ID
2206015134W