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Job Description

Inviting Applications for Manager Reg CMC Strategy, SI LCM

Location : Chennai

Experience : 6+ Years

Preferred candidate profile

• Preferred Education: Bachelors or Masters in Science / Pharmacy
• Preferred Experience: Minimum 08 Years in working independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization with major experience in handling new submissions / post approval changes to health authorities especially of US and EU(link removed)

• Experience in filing Sterile injectables submission is preferable(link removed)>

• Preferred Attributes: Good oral and written English communication skills. Good conceptual, analytical, problem solving, and organizational skills. Administrative capabilities to manage a team. Good interpersonal and negotiating skills. Good ability to collaborate across functions, cultures and time zones. Well-organized and accustomed to maintaining excellent records.
• Technical Skills: Regulatory requirements of post approval changes of various global regulatory agencies including USFDA and EMA & preferably other Global Health Authorities, eg. Health Canada, TGA, etc.; ICH Quality Guidance;
• Sterile injectable manufacturing and regulatory data requirements for submission(link removed)>
• Intermediate level of knowledge on general standards, processes, policies and key dossier execution tools of Pfizer.

Regards,

TA team

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