Regulatory Affairs Manager Job Description
This is a pivotal role in our organization where you will be responsible for developing and implementing regulatory strategies to support product development and lifecycle management.
You will manage a team of Regulatory Affairs Officers to ensure our products comply with all relevant regulations and standards. You will also be responsible for integrating new portfolio acquisitions, leading projects to identify gaps in dossiers, and devising plans to resolve these gaps.
In addition, you will lead meetings with regulatory authorities, lead regulatory aspects of internationalizing products, and monitor and interpret regulatory trends and changes relevant to the industry.
Key Responsibilities:
* Develop and implement regulatory strategies to support product development and lifecycle management
* Manage a team of Regulatory Affairs Officers to ensure compliance with regulations and standards
* Integrate new portfolio acquisitions into multiple markets
* Lead projects to identify gaps in dossiers and devise plans to resolve them
* Lead meetings with regulatory authorities
* Monitor and interpret regulatory trends and changes relevant to the industry
Required Skills and Qualifications:
We are seeking an individual with a strong knowledge of global regulatory frameworks, including MRP, DCP, and CP. Experience in medical devices is highly desirable. The ideal candidate should have excellent attention to detail, organizational skills, and be able to work on their own initiative.
The successful candidate will have 8-10 years of previous experience in a similar role and be able to drive results on a timely basis while seeing things through to conclusion.
Benefits:
This role offers a unique opportunity to join a growing organization and contribute to its continued success. As a key member of our team, you will have the chance to develop your skills and expertise in a dynamic and supportive environment.
You will also have access to ongoing training and development opportunities to help you stay up-to-date with the latest regulatory requirements and best practices.
Others:
If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.