Regulatory Affairs Expert

2 weeks ago

Singapore beBeeRegulator Full time $90,000 - $120,000

Job Title: Regulatory Affairs Executive/Manager

Job Description:

This role offers an exciting opportunity to contribute to the success of our company by driving regulatory activities and ensuring compliance with regulations.

You will play a pivotal role in supporting business operations, including planning, strategizing, and monitoring regulatory filings to ensure timely submissions and approvals for product registrations and life cycle management.

Key responsibilities include managing product life cycle maintenance, planning and submitting labeling updates, building effective working relationships with regulatory agencies, and collaborating with internal functions to develop and implement regulatory plans that support commercial goals and product launch excellence.

Additionally, you will be responsible for ensuring compliance with local, regional, and corporate regulatory SOPs and processes, obtaining relevant licenses and import/export permits, and providing regulatory input to support promotional materials and activities.

  • Plan, strategize, and monitor regulatory filings to ensure timely submissions and approvals of new product registrations, line extensions, variation applications, and clinical trial applications.
  • Liaise with local regulatory authorities and Area/Global Regulatory to deliver timely and commercially advantageous license approvals.
  • Manage product life cycle maintenance, such as changes in source, formulation, or shelf life, to ensure no impact on supply due to regulatory reasons.
  • Plan and submit labelling updates in accordance with central requirements, and support pack changes and artwork development processes to ensure compliance with local registered details and corporate prescribing information, while maximizing the commercial value of the label.
  • Build effective working relationships with the regulatory agency (e.g., HSA) and follow up closely on approvals for product registrations and variations.
  • Collaborate with all appropriate local functions to develop and implement the best regulatory plans that support commercial goals and product launch excellence.
  • Ensure compliance with local, regional, and corporate regulatory SOPs and processes. Obtain all relevant licenses and import/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 providing regulatory input to the TTS, local repacking, change control, and release of the first shipment of new products to ensure compliance with local registered details. Provide regulatory support for product incidents, recalls, and audit activities as applicable.
Required Skills and Qualifications:
  • Bachelor's degree in pharmacy or a science-based discipline (Pharmacy preferred).
  • Knowledge of pharmaceuticals, including pharmacology and technical processes such as manufacturing and quality control, gained through academic and professional experience.
  • Proven regulatory affairs experience in pharmaceuticals.
Why Join Us?

We are committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact, and doing the right thing is the foundation for how we deliver for patients, shareholders, and our people.

At our company, we aim to positively impact the health of 2.5 billion people by the end of the decade. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

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