
Compliance Regulatory Specialist
4 days ago
You will play a pivotal role in ensuring the global regulatory submission and dossier publishing process is seamless. Your primary responsibilities include compiling and maintaining regulatory documentation in accordance with established procedures.
Main Responsibilities- Perform day-to-day activities related to global regulatory submission and dossier publishing, including file optimization and quality control.
- Compile and maintain regulatory documentation as per procedure in client repositories.
- Format files using software provided by clients, creating bookmarks and hyperlinks.
- Peer-review work and provide support for other regulatory-related activities.
- Interact with stakeholders during report and regulatory documentation preparation and quality control.
- Ensure compliance with established procedures and guidelines.
- Maintain accurate records of regulatory documentation.
- Collaborate with cross-functional teams to achieve regulatory objectives.
- Stay up-to-date with industry developments and regulations.
- Analyze data and metrics to inform regulatory decisions.
- Bachelor's degree in Science, Computer Science, or Engineering.
- At least 1 year of experience in the pharmaceutical industry, Medical Device, or related field.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Ability to work in a fast-paced environment.
- Attention to detail and organizational skills.
- Proficiency in software applications relevant to the role.
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