Job Description
Regulatory Affairs Manager
The Regulatory Affairs Manager will oversee the strategy implementation and operations for managing regulatory affairs within a multinational medical device and healthcare company.
* Develop and implement regulatory strategies for product registration submissions, progress reports, supplements, amendments, and periodic experience reports.
* Interact with regulatory agencies to expedite approval of pending registrations.
* Serve as regulatory liaison throughout the product lifecycle, providing guidance on regulatory requirements and ensuring compliance.
* Participate in product plan development and implementation, regulatory strategy, risk management, and chemistry manufacturing control (CMC).
* Ensure timely approval of new drugs, biologics, or medical devices and continued approval of marketed products.
Requirements:
* Minimum Level 8 Degree in Engineering or Science or related discipline.
* Minimum of 5 years of experience in a similar position, with experience working with EU Regulatory bodies and international regulatory submissions.
* Manufacturing operations and manufacturing change experience.
* People management experience.
* Strong attention to detail and solid communication skills.
* Experience reviewing manufacturing changes and optimizing regulatory acceptance processes.
Key Skills:
* Ability to adapt to change and work effectively under tight deadlines.
* Capacity to communicate complex regulatory information clearly and concisely.
* Strong organizational skills and ability to manage multiple projects simultaneously.