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RA head

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Our client is seeking a Regulatory Affairs Head to join their team in Taipei. This role offers an exciting opportunity to propose and implement regulatory strategies for product profiles and life-cycle management. The successful candidate will ensure all regulatory actions are compliant with local regulations and internal SOPs, while also building relationships with official bodies.

What you'll do:

As the Regulatory Affairs Head, your role will be pivotal in proposing and implementing regulatory strategies that optimize product profiles and manage their life-cycle. You will ensure that all regulatory actions comply with both local regulations and internal SOPs. Your ability to build relationships with official bodies will be crucial as you handle regulatory initiatives for assigned projects. You will also be responsible for the regulatory plans, submission, and approval of all new products in Taiwan.

  • Propose appropriate regulatory strategies for optimizing product profiles and life-cycle management
  • Ensure all regulatory actions are in compliance with local regulations and internal SOP
  • Support the brand team to achieve company defined targets
  • Build relationships with official bodies, handle regulatory initiatives for assigned projects
  • Responsible for regulatory plans, submission, and approval for all new products and life cycle management of marketed products in Taiwan, aligned with business strategies and plans
  • Experience in CMC (selecting drug substances, developing formulation, considering packaging, setting quality standards, planning various tests, developing test methods, scale-up) at a pharmaceutical company

What you bring:

The ideal candidate for the Regulatory Affairs Head position brings proven experience in proposing and implementing regulatory strategies. You have a strong understanding of local regulations and internal SOPs. Your ability to build relationships with official bodies is commendable. You have handled regulatory initiatives for assigned projects before. Your experience in CMC at a pharmaceutical company sets you apart from others.

  • Proven experience in proposing and implementing regulatory strategies
  • Strong understanding of local regulations and internal SOPs
  • Ability to build relationships with official bodies
  • Experience handling regulatory initiatives for assigned projects
  • Experience in CMC at a pharmaceutical company
  • Understanding of each country's compendial (JP, USP, EP, etc.) and ICH guidelines

What sets this company apart:

Our client is a leading player in the pharmaceutical industry. They are known for their commitment to innovation, quality, and patient safety. They offer a supportive and inclusive work environment where every team member is valued for their unique contributions. This is an excellent opportunity to join a company that values growth, leadership, and supportive leadership.

What's next:

If you're ready to take the next step in your career with a leading pharmaceutical company, don't hesitate!

Contract Type: FULL_TIME

Specialism: Healthcare

Focus: RA & QA

Industry: Pharmaceuticals

Salary: Negotiable

Workplace Type: Hybrid

Experience Level: Director

Location: Taipei

Job Reference: 4IRFV1-F21C4BFF

Date posted: 16 January 2025

Consultant: Rica Chuang

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