Pfizer india opens for position as Officer / Executive - Regulatory Affairs
Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Post: Officer / Executive - Regulatory Affairs
Reporting into: Regulatory Manager
1. Author high-quality CMC documentation during development and product registration, respecting agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
2. Write high-quality CMC documentation for marketed products, obtaining rapid and advantageous registrations of change, or for routine maintenance such as renewals, respecting agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
3. Prepare CMC responses to health authority questions, during development, registration, and product lifecycle.
4. Identify the required documentation for submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
5. Identify quality and/or timeliness issues with source documents, as early as possible.
6. Participate as a member of the global CMC subteam by contributing to defining the regulatory strategy and identifying the critical issues. Additionally, inform the team of any potential issues which may affect the quality of the documentation or submission timelines.
7. Maintain the project planning system for assigned projects/ products.
8. Communicate lessons learned.
9. Develop up-to-date knowledge with regard to guidelines and regulatory as well as technical trends.
Essential: Masters degree in Pharmacy/ Biotechnology/ Science or equivalent
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