Regulatory Affairs, Associate Manager

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.

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

Travel: