Opportunity for M.Pharm, B.Pharm in Regulatory Affairs CMC at Pfizer
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.
Post : Trainee Executive, Regulatory Affairs CMC, Upjohn
• Serving as CMC representative on assigned core project(s), and help GRS-CMC in managing project activities, help develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.
• Help GRS-CMC complete the task by Prioritizing & completing assigned workload appropriately under minimum supervision.
• Presenting and articulating issues for resolution, communicating regularly with GRS-CMC to ensure alignment
• Authoring and/or coordinating CMC activities for new registrations, post approval changes, renewals, annual reports and line extensions to meet filing requirements. Coordinating & contributing to responses to Agency queries and performing quality review of regulatory CMC submissions.
• Developing effective relationships with local & global internal partners, i.e., R&D, PGS, Country Regulatory Leads, other CMC lines.
• Bachelor’s / Master’s degree in pharmaceutical sciences &/or technical discipline with 0-1 years of relevant experience in the pharmaceutical industry
• Advanced skills in written & oral communications are mandatory.
• Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.
• An understanding of regulatory requirements & expectations, criteria for submission & approval globally.
• Updates, interprets, and applies global & regional CMC guidelines. Ability to contribute to global regulatory strategies by proactively discussing with partners.
• Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.
• Emerging awareness of new scientific or manufacturing technology.
Experience : 0-1 years
Qualification : B.Pharm, M.Pharm
Location : Chennai
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs CMC
ID : 4784258
End Date : 15th June, 2020
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