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Regulatory Affairs, Associate Manager - 2406182640W
Description
Position Summary:
Assisting AD RA or equivalent to provide guidance and leadership to the team in terms of
Coordinates, compiles, and submits new drug applications (NDAs), product line extensions (including new indication) and Variations update to Health Authority.
Ensure compliance to company SOP and Quality Management System.
Lead the team with a talent development mindset and adhering to principles of DE&I
This role is responsible for regulatory activities to support and grow the business in line with the company goals while adhering to Johnson & Johnson’s CREDO.
This is also a people management role.
Key Responsibilities:
Ensure timely product registration by agreed internal timelines
Responsible for effective product lifecycle management to ensure license maintenance and supply continuity
Prepares responses to regulatory agencies’ questions and other correspondences, in collaboration with local and global functional teams
Maintain high level of awareness towards regulatory guidelines/directives/national requirements and identify business impact if any
Interact with regulatory agency personnel to expedite approval of pending application and to resolve regulatory matters
Collaborate with management and internal stakeholders (eg. Medical Affairs, Marketing) to manage product strategy, local registration and launch activities. Align filing plans and timelines with internal stakeholders including management, business partners and regional office.
Ensure adherence to standard operating procedures and protocol for the timely approval of marketed drugs
Ensure compliance to J&J and local regulatory guidelines
Provide ad-hoc local assessment on regulatory filings
Manage and maintain local and global regulatory tracking systems
Ensure post-approval commitments by the health authority are managed in a compliant manner.
Qualifications
Bachelor's degree or equivalent in Science, Pharmacy or related discipline;
Excellent verbal and written communication skills - proficiency in written and oral English is required;
Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor;
Proactive team player, able to take charge and follow-through;
Proficiency with Microsoft applications such as Excel, Word, PowerPoint.
Excellent interpersonal & communication skills
Demonstrate strong planning, organizational and decision making skills
Good team-player with strong interdependent collaboration partnership
Meticulous, strong analytical and scientific skills
Results oriented with high sense of urgency
High integrity, ethical & professional
Independent, self-driven and change agent
Coaching and mentoring where applicable
Good business acumen
Primary Location Asia Pacific-Malaysia-Selangor-Petaling Jaya
Organization Johnson & Johnson Sdn. Bhd. (8275)
Job Function Regulatory Affairs
Req ID: 2406182640W