Regulatory Affairs Manager

1 month ago

Singapur, Singapore 812 GlaxoSmithKline Pte Limited Full time

Job Summary

The Regulatory Affairs Manager at 812 GlaxoSmithKline Pte Limited will lead the portfolio life cycle management, drive new registration filings, and manage regulatory activities and labelling updates for products in defined therapeutic areas.

Key Responsibilities

  • Plan, strategize, and monitor regulatory filings for timely submissions and approvals of new product registrations, line extensions, and variation applications.
  • Liaise with local regulatory authorities and Area/Global Regulatory to deliver timely and commercially advantageous license approvals.
  • Respond to regulatory questions in a timely manner and following consultation with relevant stakeholders.
  • Manage product life cycle maintenance, ensuring no impact to supply due to regulatory reasons.
  • Plan and submit labeling updates in line with central requirements and support pack changes and artwork development process to ensure compliance with local registered details and corporate prescribing information.
  • Build effective working relationships with the regulatory agency and follow up closely on approvals of product registration and variations.
  • Work with local functions to develop and implement the best regulatory plans to support commercial goals and product launch excellence.
  • Ensure compliance with local, regional, and Corporate regulatory SOPs and processes. Obtain all relevant licenses and import and export permits in compliance with regulatory requirements.
  • Provide regulatory input to support promotional materials and activities in accordance with local regulatory and internal requirements.
  • Support QMS and quality compliance activities, including provision of regulatory input to the TTS, local repacking, change control, release of first shipment of new product to ensure compliance with the local registered details.

Requirements

  • Science-based degree (Pharmacy - preferred).
  • About 6 years' local regulatory experience in pharmaceuticals MNC for Manager position.
  • Good knowledge of current regulatory requirements.
  • General pharmaceutical products knowledge.
  • Professional written and verbal communication skills.

Preferred Qualifications

  • Team work and people skills.
  • Good time management skills, with ability to multi-task and work under pressure.
  • Works with a spirit of continuous improvement and innovation.
  • Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour, and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills, and share learning.
  • Sustaining energy and well-being.
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.

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