Job Description

A Pharmaceutical MNC is seeking a visionary to strategize their visionary expansion goals in the APAC region and leading their RA team through successful execution.

As a Regulatory Affairs Director, you have the opportunity to make a significant impact on the organization and its stakeholders. By navigating the regulatory landscape, developing strategies, and effectively leading cross-functional teams, you inspire collaboration, innovation, and a shared sense of purpose.

Your role as a Regulatory Affairs Director offers the chance to inspire and guide others towards achieving regulatory excellence, shaping the future of the organization. Main Responsibilities

• Leading cross-functional teams for regulatory submissions in the region, managing interactions and collaborations with senior leaders.
• Maintaining a comprehensive knowledge of submission planning activities within the assigned portfolio.
• Developing and implementing regulatory program strategies in the Asia Pacific markets for efficient submission planning and execution.
• Coordinating and streamlining communication to address urgent matters and maintain balanced workloads across the region.
• Overseeing regulatory projects from authorization to delivery for country regulatory affairs teams and Health Authorities, with a focus on regulatory operations.
• Developing and maintaining regulatory submission plans for key projects/products, diligently tracking project milestones.
• Actively participating in or leading cross-functional forums and meetings.
• Collaborating closely on assigned products/projects, ensuring effective coordination and integration.
• Providing effective oversight of outsourced activities, ensuring quality, compliance, and performance against key criteria.

Criteria * Education and Experience: A bachelor\'s degree in a Life Science-related discipline with 10-12 years of experience in Regulatory Affairs, with at least 3 - 5 years in a similar leadership capacity.

• Regulatory Expertise: In-depth understanding of regulatory submission standards, procedures, and the drug development landscape across the APAC region.
• Strong Planning and Delivery Skills: Capability to oversee complex planning, tracking, and delivery of regulatory content, ensuring alignment with regulatory strategy, compliance, and customer needs.
• Leadership and Collaboration: Demonstrated experience in leading cross-functional teams to ensure high-quality and timely submissions, fostering collaboration and effective communication.
• Adaptability and Innovation: Ability to navigate unfamiliar situations, embracing ambiguity and providing clear direction, while maintaining a service delivery mindset driven by innovation and continuous process improvements.

If you have a strong background in regulatory affairs, exceptional leadership skills, and a passion for driving regulatory excellence, I invite you to apply for this role with your most updated resume, outlining your relevant experience and qualifications.

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

Additional Information

Career Level

Senior Manager

Qualification

Not Specified

Years of Experience

12 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