Deskripsi pekerjaan Regulatory Supervisor Blesscom
# REGULATORY SUPERVISOR
We are currently looking for a Regulatory Supervisor to support and oversee regulatory activities related to site projects under PT Sterling Products Indonesia.
In this role, you will be responsible for ensuring regulatory submissions and site registration activities are completed accurately, compliantly, and on time to support project execution and business objectives.
## Job Responsibilities
### 1. Regulatory Submission Process
* Prepare and compile complete regulatory dossiers, including safety, administrative, and other required documentation for regulatory submission.
* Work closely with Site Subject Matter Experts (SMEs) to ensure site-specific documentation is accurate and complete.
* Ensure Right First Time regulatory submissions by maintaining the accuracy and completeness of submitted documents.
* Facilitate discussions and consultations with regulatory authorities to address questions or concerns and support a smooth approval process.
### 2. Site Registration
* Manage and support site registration activities with TGA and other relevant regulatory authorities.
* Ensure all required documentation and procedures are completed in accordance with applicable regulatory requirements.
* Support administrative activities related to regulatory processes, including document management, record maintenance, and coordination.
### 3. Tracking, Reporting & Escalation
* Monitor and track ongoing regulatory activities and project timelines.
* Provide regular updates to relevant stakeholders regarding the progress and status of regulatory activities.
* Identify potential risks or issues and promptly escalate them to the appropriate stakeholders.
* Propose and support mitigation actions to minimize regulatory and project-related risks.
## Qualifications
* Experience and knowledge in Regulatory Affairs and Regulatory Submission.
* Familiar with preparing regulatory dossiers and implementing Good Regulatory Submission practices.
* Experience in product registration submission and familiarity with the BPOM system.
* Knowledge of cGMP and applicable local and international regulatory requirements, including FDA, WHO, MHRA, and EMA.
* Understanding of regulatory activities related to periodic product reviews, regulatory reporting, CAPA, and Change Control Management.
* Basic understanding of manufacturing operations.
* Strong analytical, numerical, and problem-solving skills.
* Good technical writing and verbal communication skills in English.
* Excellent communication and interpersonal skills, with the ability to work effectively with multiple stakeholders.
* High level of ethics, integrity, confidentiality, and professionalism.
* Able to work independently while also collaborating effectively within a team.
If you have the relevant experience and are interested in this opportunity, please submit your application through this job posting.
