Job Description

I am currently representing a reputable lifescience company with a focus on personalized treatments and transformative experiences. They are currently seeking an exceptional Associate Director, Regulatory Affairs (APAC) who will play a vital role in shaping and executing their regulatory strategy to support their business operations.

This is an exciting opportunity to join a dynamic team and contribute to the success of the organization in the ever-evolving regulatory landscape. Roles and Responsibilities

In this position, you will be at the forefront of developing and implementing regulatory strategies that align with their business goals. Your expertise and leadership will be crucial in navigating the complex regulatory environment, ensuring compliance, and facilitating the smooth operation of their products and services.

• Develop and execute regulatory strategies to support product registration and commercialization.
• Collaborate with cross-functional teams to ensure regulatory compliance throughout the product life cycle.
• Stay updated on global regulations, guidelines, and industry trends to anticipate potential impacts and proactively address regulatory challenges.
• Prepare and submit regulatory submissions.
• Engage with regulatory agencies and authorities to establish and maintain productive relationships, representing the company\'s interests.
• Conduct regulatory assessments and provide guidance on product labeling, advertising, and promotional materials.
• Lead and manage regulatory projects, ensuring timely completion and adherence to quality standards.
• Monitor and assess the impact of changing regulatory requirements on existing products and processes, and develop strategies for effective adaptation.
• Collaborate with internal stakeholders to provide regulatory guidance and support for product development, including risk assessments and mitigation plans.
• Ensure compliance with regulatory reporting requirements, including adverse event reporting and post-market surveillance activities.

Experience Required

• Bachelor\'s degree in a relevant scientific discipline. Pharmacy is an added advantage.
• Minimum 8 - 10 years\' experience in regulatory affairs. Experience with medical devices is a bonus.
• Extensive knowledge of global regulatory requirements and guidelines.
• Proven success in developing and executing regulatory strategies.

Interested Applicants

If you are a driven and results-oriented regulatory professional looking to make a significant impact in a dynamic and innovative company, I highly encourage you to apply for the role of Associate Director, Regulatory Affairs (APAC).

To apply, please submit your most updated resume, outlining your relevant experience and qualifications.

Looking forward to hearing from you.

Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502

Additional Information

Career Level

Senior Manager

Qualification

Not Specified

Years of Experience

10 years

Job Type

Full-Time

Job Specializations

,

Company Overview

Meet Integrity. We\'re a leading recruitment firm specializing in the areas of Life Sciences and Engineering with over 100 years of combined experience in the industry. We\'ve helped recruit the most prized talent in a wide variety of Life Science and Construction sectors.

With 40% of our waking time dedicated to work, we know the vital importance of how smallest actions can create the biggest impact in people\'s lives. This is exactly why our friendly team of skilled experts always prioritizes actions based on core values over personal gain.

The secret to our business is personal relationships. Because People Matter.

We\'ve been very fortunate to assist with the recruitment of some of the most talented and dynamic talent for many of the largest and smallest employers. These are businesses who were in need of elite recruits who possessed specific talents, unique skills and other technical disciplines. Reach out to us to to discover even more about how we can help you with all of your recruiting needs or your own career.

Additional Company Information

Registration No.

201634573Z

EA No.

17C8502

Company Size

1 - 50 Employees

Industry

Human Resources Management / Consulting

Benefits & Others

Miscellaneous allowance, Long hours, Formal (e.g. Shirts + Ties)

Integrity Partners