Opening for B.Pharm, M.Pharm as Manager in Pfizer
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: Manager - Regulatoy Affairs
Responsible for preparation and/or provide review support and guidance to product owners on technical and regulatory knowledge towards preparation of Site transfer Global regulatory strategy document (GRSD), supplements/variations and other regulatory documents
Functions as product owner for site transfer submissions for assigned products, working with cross functional site teams and corporate regulatory team to ensure preparation of quality global regulatory strategy document and supplements / variations.
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
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.
Bachelors or Master in Science / Pharmacy
Minimum 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, EMA and other EU authorities. Experience in handling site transfer submissions is preferable.
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 tools
Regulatory requirements for handling Technology Transfer activities and submission of supplements/variation to various global regulatory agencies especially USFDA and preferably EMA & other EU health Authorities, Health Canada and TGA.
ICH Quality Guidances
Sterile injectable manufacturing and regulatory data requirements for submission.
Good level of knowledge on general standards, processes and policies of Pharmaceutical manufacturing Industry.
Functional Area: Regulatory Affairs
Education: B.Pharm / MPharm, BSc, MSc
Industry Type: Pharma/ Healthcare/ Clinical research
LAST DATE: 25th OCT, 2020
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