Regulatory Affairs Pharmacist

IMMEDIATE VACANCY AT ISKANDAR PUTERI, JOHOR

We are looking for an experienced Regulatory Affairs Pharmacist to ensure our pharmaceutical products comply with regulations and standards, managing registration processes, maintaining compliance, and advising on regulatory matters to ensure safe and effective drug development and distribution.

Key Responsibilities:

1. Regulatory Compliance: Ensure all aspects of drug development, manufacturing, and marketing comply with relevant regulations and guidelines.
2. Registration and Dossier Management: Prepare and submit registration dossiers to regulatory agencies, ensuring timely and successful product registration.
3. Post-Approval Activities: Manage post-approval activities, including monitoring product safety, addressing adverse events, and ensuring ongoing compliance.
4. Regulatory Strategy: Develop and implement regulatory strategies to ensure products are approved and maintained in target markets.
5. Liaising with Authority: Act as a point of contact between the company and regulatory authorities, providing information, answering questions, and addressing any concerns or issues that may arise.
6. Communication and Collaboration: Interact with regulatory internal teams (e.g., R&D, manufacturing, marketing) and external stakeholders to ensure effective communication and collaboration.
7. Staying Current/Up-To-Date: Keep abreast of changes in regulatory requirements and guidelines.
8. Quality Assurance: Ensure that all products meet the required quality standards and comply with Good Manufacturing Practices (GMP).
9. Labeling and Packaging: Ensure that product labeling and packaging comply with regulatory requirements.
10. Risk Management: Contribute to the development and implementation of risk management plans.
11. Data Integrity: Maintain accurate and complete records of regulatory activities.

Qualifications:

1. Bachelor’s degree in pharmacy.
2. Fully Registered Pharmacist with the Pharmacy Board of Malaysia.
3. Able to apply for Poison A license for the premise.

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