Job Summary
We are seeking a highly skilled Regulatory Affairs Specialist to oversee the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
The successful candidate will interact with regulatory agencies to expedite approval of pending registration, serve as regulatory liaison throughout the product lifecycle, and participate in key initiatives such as product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
Key Responsibilities
* Develop and implement effective strategies for product registration submissions, ensuring timely approval of new drugs, biologics or medical devices, and continued approval of marketed products.
* Serve as a regulatory representative to marketing, research teams, and regulatory agencies, advising on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretations.
* Collaborate with cross-functional teams to resolve issues regarding non-conformance and ensure compliance with EU and US regulatory bodies.
Requirements
* Level 8 Degree in Engineering or Science or related discipline.
* Minimum 5 years of experience in a similar position, with expertise in EU Regulatory bodies, applications, and submissions, or equivalent international experience.
* Proven experience in manufacturing operations, manufacturing change management, and issue resolution.
* Strong attention to detail, solid communication skills, and ability to communicate effectively at all levels.
* Experience working with EU and US regulatory bodies, with strong organisational skills.
Please note that if you are not a passport holder of the country for which you are applying, you may need a work permit. At TN-Ireland, we value diversity and inclusion. We welcome applications from qualified candidates who share our commitment to excellence and innovation.