RegulatorySpecialist

## **JOB DESCRIPTION:** **MAIN PURPOSE OF ROLE** Experienced professional individual contributor that works under limited supervision. Applies subject matter knowledge in the area of Regulatory Affairs. Requires capacity to apply skills/knowledge within the context of specific needs or requirements. **MAIN RESPONSIBILITIES** • As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports. • Interacts with regulatory agency to expedite approval of pending registration. • Serves as regulatory liaison throughout product lifecycle. • Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC). • Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products. • Serves as regulatory representative to marketing, research teams and regulatory agencies. • Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. **The base pay for this position is** N/A In specific locations, the pay range may vary from the range posted. ## **JOB FAMILY:** Regulatory Operations ## **DIVISION:** CRLB Core Lab ## **LOCATION:** Philippines > Taguig City : Venice Corporate Center ## **ADDITIONAL LOCATIONS:** ## **WORK SHIFT:** Standard ## **TRAVEL:** Not specified ## **MEDICAL SURVEILLANCE:** Not Applicable ## **SIGNIFICANT WORK ACTIVITIES:** Not Applicable