*Hi,* Hope you are doing good !!!
This is Vijay from Reliable Software Resources Inc, this mail is regarding the job opportunity as a* “CMC Manager”* Please find the requirement details and let me know your interest. Thanks !!! *POSITION/TITLE: CMC Manager * *Location: Morristown, NJ* *DEPARTMENT/TEAM DESCRIPTION * The CMC Documentation Team is responsible for the development of Chemistry, Manufacturing and Control (Module 3) documentation for the commercial products within the portfolio. *POSITION SUMMARY * Under the broad guidance of the CMC product leads, the job entails supporting the CMC Documentation team in the preparation of CMC registration documents. The person will be responsible for the creation and maintenance of regulatory CMC documents in the controlled document management repository. The job purpose is to prepare technical CMC registration documents in order to maintain the existing marketing authorization (i.e. dossier updates, variations, renewals, response to deficiency letters, compliance gap closures) in various countries where business is being conducted. *POSITION DUTIES & RESPONSIBILITIES * Lead the development of technical documents to ensure the on-time compilation of high quality CTD Module 3 and QOS documents that are ready for submission Discuss and align with project team on strategy for maintenance activities for products under his or her responsibility Evaluate change requests with a goal of defining technical requirements according to guidelines, and evaluate and provide input on technical data to support the change. Create or update the technical registration dossiers (CTD Module 3 and QOS or equivalent) of pharmaceutical products Maintain knowledge of current industry requirements and standards for CTD Module 3 and QOS or equivalent Work cross functionally to coordinate the preparation of draft responses to technical regulatory questions from health authorities including writing of expert statements and scientific justifications *REQUIREMENTS/PREFERENCES * Education Requirement(s): Bachelor’s degree with 2 or more years of proven experience Master’s degree with 1 or more years of proven experience *Skill & Competency Requirements: * Experience in global CMC/Module 3 creation Demonstrated ability/experience analyzing technical reports (manufacturing, analytical and stability) Excellent writing skills Demonstrated ability/experience managing IT based scientific systems *Preferences: * Experienced in the US regulatory environment Experience in post-approval CMC changes Fluent in English (German and/or French speaking is a plus) -- *Regards,* *Vijay D* Sr. Recruiter Phone: 312 967 7072 22260 Haggerty Rd, Suite # 285,Northville, MI 48167. Email: *vija...@rsrit.com <vija...@rsrit.com> *I *www.rsrit.com <http://www.rsrit.com/>* *www.linkedin.com/in/vijay-d-97047a65 <http://www.linkedin.com/in/vijay-d-97047a65>* -- You received this message because you are subscribed to the Google Groups "Resumes" group. To unsubscribe from this group and stop receiving emails from it, send an email to resumes+unsubscr...@googlegroups.com. To post to this group, send email to resumes@googlegroups.com. Visit this group at https://groups.google.com/group/resumes. For more options, visit https://groups.google.com/d/optout.
