Job Summary
We are seeking an experienced Regulatory Affairs Specialist to oversee the implementation and operations of product registration submissions, progress reports, supplements, amendments, or periodic experience reports. This role requires strong attention to detail, solid communication skills, and the ability to communicate at all levels.
Main Responsibilities:
* Implement regulatory strategies and ensure timely approval of new drugs, biologics, or medical devices, as well as continued approval of marketed products.
* Serve as a regulatory liaison throughout the product lifecycle, interacting with regulatory agencies to expedite approval of pending registrations.
* Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretations.
* Participate in product plan development and implementation, regulatory strategy, risk management, and chemistry manufacturing control (CMC).
Requirements:
* Bachelor's Degree in Engineering or Science or related discipline.
* A minimum of 5 years of experience in a similar position, with experience working with EU Regulatory bodies in regards to applications and submissions or equivalent international experience.
* Manufacturing operations and manufacturing change experience.
* People management experience.
* Strong organizational skills.
* Experience resolving issues regarding non-conformance.