Job Description

You will be handling a portfolio of products covering critical therapeutic areas (oncology/rare disease) and managing regulatory activities across the APAC region.
MAIN RESPONSIBILITIES * Utilize exceptional interpersonal skills and influence to establish strong relationships with stakeholders and develop effective regulatory strategies for the long term.

• Manage the product lifecycle and regional submission pipelines in an efficient manner, leveraging technical and strategic expertise.
• Ensure that all regulatory processes are aligned with global standards and frameworks, while collaborating with internal and external stakeholders.
• Monitor regulatory intelligence both locally and internationally, anticipate potential issues, and develop strategies to mitigate them.
• Provide regulatory guidance to cross-functional teams and internal teams, as well as responses to health authorities.
• Conduct regulatory assessments of new product opportunities and advise on necessary regulatory requirements for bringing them to market.
• Manage regulatory projects and timelines, ensuring their timely completion.
• Maintain current knowledge of regulatory requirements and changes to regulations.
• Ensure compliance with all regulatory requirements, including the preparation and submission of regulatory filings.
• Represent the company in regulatory affairs matters and communicate with regulatory agencies on behalf of the company.

QUALIFICATION

• At least 5 - 8 years\' experience in the pharmaceutical industry with experience working with innovative pharmaceutical pipelines in either chemical or biological entities
• Relevant Bachelor\'s Degree (BSc. Pharmacy is an added advantage)
• Strong understanding of global regulatory frameworks and processes

INTERESTED APPLICANTS

If you area passionate about contributing to cutting-edge pharmaceutical innovations, please apply with your updated CV. Suitable candidates will be contacted for a confidential discussion regarding this exciting opportunity. Not the right opportunity?

We\'re always looking out for the best talents in the life science industry. If you are currently seeking exciting opportunities within the pharmaceuticals, medical devices, in-vitro diagnostics (IVD), or consumer health industry, do reach out for a confidential chat.

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

Additional Information

Career Level

Manager

Qualification

Bachelor\'s Degree, Post Graduate Diploma, Professional Degree

Years of Experience

5 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

Average Processing Time

2 days

Industry

Human Resources Management / Consulting

Benefits & Others

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

Integrity Partners