Global Regulatory Lead

4 days ago


Manila, National Capital Region, Philippines Michael Page Full time
About the Role

We are seeking a highly skilled Regulatory Affairs Manager to join our client's team. As a key member of the team, you will be responsible for ensuring compliance with FDA guidelines and other international regulations.

Responsibilities

The responsibilities of this role include:

  • Developing and maintaining SOPs and local working practices.
  • Aligning regulatory priorities with business needs, allocating resources, and managing workloads.
  • Staying current on relevant regulations and proposed rules.
  • Managing audits, inspections, and product recalls.

In addition to these responsibilities, you will contribute to clinical trial protocol development, communicate regulatory information across departments, and develop strategies and plans for new product submissions.

Requirements

To succeed in this role, you will need:

  • A Bachelor's degree in Pharmacy/Nursing or a related field.
  • 10+ years of experience in regulatory affairs, preferably in the pharmaceutical industry.
  • Strong communication, interpersonal, and problem-solving skills.

You should also have experience with project management, time management, and negotiation.

What's on Offer

We offer a competitive salary and benefits package, as well as opportunities for career growth and professional development within a global organization.

  • Career development opportunities within a global organization.
  • A chance to contribute to a company that is improving lives through quality health products.


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