Key Responsibilities
* Develop and implement strategic plans for product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
* Maintain communication with regulatory agencies to expedite the approval of pending registrations.
* Act as a regulatory liaison throughout the product lifecycle, ensuring compliance with relevant regulations.
* Contribute to product plan development, regulatory strategy, risk management, and chemistry manufacturing control (CMC).
* Ensure timely approvals for new drugs, biologics, or medical devices, as well as continued approval of marketed products.
* Serve as the regulatory representative for marketing, research teams, and regulatory agencies.
* Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretations.
Requirements
* Bachelor's degree in Engineering or Science, or related field.
* A minimum of 5 years of experience in a similar position, including experience with EU Regulatory bodies and equivalent international experience.
* Manufacturing operations and change management experience.
* People management experience.
* Experience resolving issues related to non-conformance.
* Strong attention to detail.
* Solid communication skills, enabling effective communication at all levels.
* Experience working with EU and US regulatory bodies.
* Strong organizational skills.