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: Senior Regulatory Officer
Job Description
Responsibilities
1. Strategic/Policy:
• Delivery on compliance in regulatory processes for all imported products marketed for Pfizer & Wyeth in India.
2. Operational:
* Regulatory Operations
• Performing all regulatory activities related to Worldwide Biopharmaceuticals Business for India.
• Analyze data and document requirements and compile dossiers to support new product launches per applicable regulatory rules and procedures.
• Compile documents for renewals, variations, line-extension and maintenance of licenses.
• Coordinate documents from Pfizer & Wyeth global teams for regulatory submissions and approvals.
• Ensure maintenance and update of regulatory database – GRS, GDMS, HATs and Epalms & PfLEET.
• Responsible for RAN management (review, response, submission and approval), e-TRAC maintenance.
• Create artworks for new product and also initiate artwork revisions.
• Ensure that all LPDs are updated.
• Responsible for keeping customers informed about progress/ delay of approvals.
• Handling other regulatory activities that may be assigned by line manager.
• Monitor compliance and implement corrective actions for ensuring delivery on regulatory benchmarks.
• Ensure updating the regulatory parameters for monthly reports.
• Demonstrate and promote Pfizer global value system across all interactions.
• Contribute to Pfizer’s quality-consciousness and research-based image.
• Generate and meet customer expectations on regulatory support and deliverables.
• Implement technology solutions for enabling better information availability.
Technical Skill Requirements:
• Competency Detail / Comments (specific skills, etc.)
• Knowledge of the India, regulatory environment and how this impacts regulatory strategy and implementation. Understanding of applicable drug regulatory laws, guidelines and environment. Handling variations and RC submissions.
• Knowledge of drug development practice, rules, regulations and guidelines. Familiarity with the regulatory updates and its impact on the business.
• Strategic Thinker Provides strategic contribution and anticipates what RA needs to contribute to get the products registered and maintain compliance.
•Communication skills Clearly conveys information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand the message.
• Negotiation skills Can negotiate skillfully with both internal and external groups. Has built a strong relationship with the internal stake holders including Distributors.
• Problem Solving
• Effectively identifies issues and challenges and works with partner groups to identify options and implement agreed upon solutions.
• Understands Business and Financial Environment Understands how role is impacted by and contributes to external business environment.
• Understands Pharmaceutical Industry To be updated on developments, issues and drivers impacting the Pharmaceutical industry.
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Qualifications
• A graduate or post-graduate degree in Pharmacy, Pharmaceutical Medicine, Pharmacology, or any other pharmaceutical regulatory discipline.
• Should have 3-4 years experience in Regulatory Affairs in the Pharmaceutical industry.
Additional Information
Experience: 3-4 Years
Job ID: 989716, 989717
Functional Area: DRA
Location: Mumbai
Last Date: 31st Dec. 2013
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