Job Description

Company: Pharmaceutical MNC

Position: Local

Product Portfolio: Innovative products with main pipeline in oncology

Reporting to: Head of RA

MAIN RESPONSIBILITIES

As the Regulatory Affairs Manager, you will bring your technical and strategic expertise to the forefront, managing the lifecycle and regional submission pipelines in a time-efficient manner. You will ensure that processes align with global standards and regulatory frameworks, while working closely with internal and external stakeholders to develop effective regulatory strategies.

• Develop and implement regulatory strategies for the company\'s products in the assigned region, in line with global standards and regulations.
• Manage the preparation and submission of regulatory applications to health authorities, including new drug applications.
• Serve as the primary contact with regulatory authorities, including communicating with them on regulatory issues and addressing inquiries and requests for information
• Maintain up-to-date knowledge of regulatory requirements, guidelines, and trends to inform regulatory strategy development.
• Work closely with internal stakeholders, such as R&D, Clinical Operations, and Marketing, to align regulatory strategies with business objectives.
• Contribute to the development of the company\'s long-term regulatory strategy, including identifying emerging regulatory trends and proposing proactive solutions.
• Ensure compliance with ethical, legal, and regulatory standards.
• Collaborate in the maintenance of the regulatory database, ensuring timely updates of regulatory information.
• Develop plans for regulatory compliance and product labeling to ensure consistency and provide guidance throughout the process of introducing products to the market.
• Keep up-to-date with changes in regulatory requirements in relevant countries by monitoring relevant regulatory changes.

REQUIREMENTS

• Relevant Bachelor\'s Degree (Bachelor\'s Degree in Pharmacy is an added advantage)
• At least 5 years in the pharmaceutical industry with experience working with innovative pharmaceutical pipelines

Candidates with more experience will be considered for Senior Manager.

ESSENTIAL QUALITIES

• Strong analytical skills to assess complex regulatory requirements and develop effective strategies to ensure compliance.
• Excellent communication skills to collaborate with cross-functional teams and communicate regulatory strategies and updates to stakeholders at all levels of the organization.
• Detail-oriented mindset to ensure accuracy and completeness in all regulatory documentation and submissions.

If you\'re seeking an enriching opportunity to elevate your career in regulatory affairs with a distinguished company, I greatly encourage you to apply with your latest CV and we shall get in touch shortly for a confidential discussion.

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

Additional Information

Career Level

Manager

Qualification

Not Specified

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

Industry

Human Resources Management / Consulting

Benefits & Others

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

Integrity Partners