Job Description

DIVISION : Johnson & Johnson Pharmaceuticals (Janssen India)

LOCATION : Gurgaon

POSITION : Liaison Manager

REPORTING TO : Director - Regulatory Affairs

POSITIONS REPORTING TO HIM/HER : Regulatory Affairs Assistant

BRIEF JOB DESCRIPTION

• Develop and maintain ethical and effective working relationship with the regulators
• Ensure timely approvals from Government/ regulatory authorities, mainly CDSCO.
• Support TA teams to build in sound regulatory strategy with predictable registration timelines for NDAs/BLAs/sNDAs/CTAs
• On time renewal of registrations and licenses to avoid impact on business continuity
• Coordination with regulatory consultant based in Delhi to ensure that the consultant operates strictly within JnJ policies and ethical standards
• Conducts all activity on behalf of the organization consistent with the JnJ Credo and all applicable internal policies.
• Contributes actively in local ARR council discussions
• Coordination with various government laboratories like CDL, CDTL, NIB, IPC, etc.
• Masters the understanding of the complex relationships, processes, laws, issues, and history which define and govern the political/legislative governmental institutions at the central and local levels.
• Participates and contributes to industry association discussions and workgroups
• Builds strong internal relationships that foster open communications and an understanding of the internal clients\' needs.
• Acts as a pro-active thinker by proposing innovative communication actions to optimize our message and the flow of information.
• Ensures consistent approach amongst various applications submitted to regulatory authority
• Creates new and innovative ways of doing things, demonstrates flexibility, open-mindedness, and adaptability to a rapidly changing environment.
• Manages multiple priorities and competing interests.
• Provides mentorship and manages regulatory assistant based in Delhi

Johnson & Johnson