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
Job Description:
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.
Education/Qualifications:
Essential: Masters degree in Pharmacy/ Biotechnology/ Science or equivalent
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Candidate Profile:
Work Experience:
Total of 3-6 years of practical experience in Regulatory Affairs/ Pharmaceutical Development/ Quality Assurance
Skills & Competencies:
1. 3–6 years practical experience (Regulatory, Galenical, Chemical/Biotech, Analytics or Quality Assurance)
2. 1–4 years knowledge of global CMC regulatory and/or CMC documentation preparation experience for ANDAs/ANADAs/MAAs/INADs/BLAs/NADAs
3. Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
4. Knowledge/experience of regulations, guidelines for NCEs, generics and product life cycle maintenance desirable.
5. Ability to work successfully with extended, multi-national project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
6. Effective planning, organizational, and interpersonal skills.
7. Excellent written/spoken interpersonal communication and negotiation skills.
8. Computer literacy.
Additional Information:
Experience: 3-6 years
Location: New Delhi
Education: M.Sc, M.Pharm
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: DRA
Job ID: 967001
LAST DATE: 30th June, 2012
TO APPLY CLICK HERE AND PUT JOB ID. AND SELECT REGION: ASIA PACIFIC; COUNTRY: INDIA;
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