JOB RESPONSIBILITIES
- Functions as product owner for site transfer submissions for assigned products, working with cross functional team, site team and corporate regulatory team to ensure preparation of quality global regulatory strategy document and supplements / variations.
- Responsible for the preparation and finalization of Global Regulatory Strategy Documents (GRSD), CTD sections of supplements / variations for site transfer submissions.
- Also provides guidance and support to Junior Product Owners in the preparation of quality global regulatory strategy document and supplements.
- Responsible for effective co-ordination with the cross functional teams at site and corporate for the review and finalization of supplements to ensure effective data presentation and quality
- Responsible for effective review and providing timely feedback to the teams on technical documents related to transfer (Technology transfer protocols), batch documents related to submission (batch records, Exhibit batch and stability protocol, etc.,)
- Provides regulatory support for Change assessment related to submissions from Vizag site
- Provides regulatory support to the cross functional teams for the assigned products ,participates and provides inputs in technical reviews and strategic discussions on regulatory submissions
- Collaborates with and ensures adequate support to the regional team to ensure completion of assigned shared task or goal.
- Identifies , assesses regulatory risks associated with assigned projects and timely communication of the issues, its impact to global regulatory management & core team and drives resolution of issues
- Drives resolution of issues. Communicates issues, impact and outcomes to global regulatory management, team lead and core team.
- Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects
- Responsible for ensuring compliance to Company's submission standards, policies and procedures.
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QUALIFICATIONS / SKILLS
Preferred Education:
Bachelors or Master in Science / Pharmacy
Preferred Experience:
Minimum 5 to 10 Years in leading independently or a team in the Regulatory Affairs function in a reputed pharmaceutical organization with major experience in handling new submissions / post approval changes to health authorities especially USFDA, Canada, Australia, New Zealand. Experience in handling site transfer submissions is preferable.
Preferred Attributes:
• Good oral and written English communication skills.
• Good conceptual, analytical, problem solving, and organizational skills
• Well-organized and accustomed to maintaining excellent records
• Good knowledge of Microsoft Office and preferably knowledge on ISI writer
Technical Skills:
• Regulatory requirements for handling Technology Transfer activities and submission of supplements/variation to various global regulatory agencies especially USFDA, Canada, Australia, New Zealand.
• ICH Quality Guidance
• Sterile injectable manufacturing and regulatory data requirements for submission. Intermediate level of knowledge on general standards, processes and policies of Hospira/Pharmaceutical manufacturing Industry.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
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