As a Pharmaceutical Regulatory Affairs Pharmacist responsible for product registration and quality documentation, your role will be pivotal in ensuring compliance with regulatory requirements and maintaining the highest standards of quality within the pharmaceutical industry. You will work closely with cross-functional teams to manage product registrations, submissions, and documentation necessary for market authorization and compliance. Your expertise will contribute to the safe and effective distribution of pharmaceutical products.
- Regulatory Compliance:
- Lead the preparation, compilation, and submission of product registration dossiers to regulatory authorities.
- Ensure all submissions adhere to local and national department of health regulatory guidelines and requirements.
- Stay updated on evolving regulatory standards and communicate potential impacts to stakeholders.
- Product Registration:
- Collaborate with internal teams, including research and development, quality assurance, and production, to gather necessary data and documentation for product registration.
- Prepare and review registration documents, including drug master files, technical dossiers, and safety data.
- Quality Documentation:
- Maintain accurate and up-to-date quality documentation, including standard operating procedures (SOPs), batch records, certificates of analysis, and stability studies.
- Oversee the creation and maintenance of product quality and technical documentation throughout the product lifecycle.
Qualifications and Skills:
- Strong attention to detail and excellent organizational skills.
- Effective communication and interpersonal skills for collaboration across departments and with regulatory agencies.
- Analytical thinking and problem-solving abilities
- bility to manage multiple tasks and deadlines simultaneously.
- Proficiency in relevant software tools and systems for documentation management and data analysis.
Send all applications to:[email protected]