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Regulatory Manager, APAC

2 weeks ago

Central Region, Singapore Private Advertiser Full time $150,000 - $200,000 per year

The primary role of the REGULATORY MANAGER, ASIA PACIFIC is to oversees the product registrations and regulatory pathways in Asia Pacific. And work with other stakeholders to create effective business and project implementation plans. He/she needs to ensure compliance with Asia Pacific regulations.

In this role, you will influence key decision-making processes with ample opportunities for enterprise-wide impact, exposure, learning and development.

Key Responsibilities:

  • Regulatory strategy and submission for Oncology, Nutrition and CNS products in Asia Pacific

  • Independently manages and executes all aspects for the successful preparation, submission and timely approval of applications, variations, post approval reporting obligations and general product life cycle management of assigned program

  • Develop, implement and maintain regulatory strategies for the products in line with the Company's global objectives and local requirements.
  • Prepare, review and submit regulatory dossiers to the Asia Pacific regulatory bodies.
  • Effectively communicates the regulatory strategies, submission plans and timelines; impact assessment of trends, regulations and changes related to the assigned programs.

  • Manage the regulatory submission process, including timely preparation of submission documents and ensuring submission within project/ commercial launch timelines,

  • Regulatory compliance

  • Ensuring compliance with Asia Pacific regulatory bodies

  • Monitory regulatory changes and emerging trends in space where the Company operates. Also provide guidance to the internal stakeholders on the changes / impact.

  • Provide regulatory input into the development and marketing of the products, not limiting to clinical trial design, labelling and promotional material review.

  • Liaison with Regulatory Authorities:

  • Act as the primary point of contact with regulatory authorities

  • Prepare and participate in meetings with regulatory agencies, including answering queries, addressing requests for additional information, and negotiating approvals.

  • Maintain productive relationships with regulatory bodies to facilitate efficient approval processes.

  • Cross-functional Collaboration:

  • Work closely with internal teams (clinical, medical affairs, manufacturing, quality assurance, and marketing) to ensure alignment on regulatory strategy and project timelines.

  • Provide regulatory input to support clinical trials, product development, and post-market activities.
  • Support the preparation of regulatory documentation for product lifecycle management, including changes to product labelling, packaging, and marketing authorizations.

Requirements:

  • A degree in life sciences, pharmacy, or a related field preferred.
  • Minimum 8 years of regulatory affairs experience in the healthcare industry in Asia Pacific
  • Experience with oncology clinical trials and regulatory requirements for investigational new drugs.
  • Solid regulatory experience, including knowledge of regulations and guidance governing drugs and biologics in development and life cycle management.
  • Excellent communication and negotiation skills, both written and verbal, with the ability to engage effectively with regulatory agencies, cross-functional teams, and senior leadership.
  • Strong problem-solving skills and the ability to navigate complex regulatory environments.
  • Demonstrated ability to manage multiple projects simultaneously, with a high degree of organization and attention to detail.
  • Ability to work independently and as part of a collaborative team in a fast-paced environment.