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CMC Regulatory Scientist

Responsibilities:




  • Preparing, revising and updating CMC sections and ancillary GMP documentation for of global Marketing Authorizations


  • Ensuring that all regulatory documents are prepared accurately, completely and on-time


  • Tracking project status and effectively communicating progress.


  • Responsible for multiple project assignments with critical timelines.



Qualifications:




  • B.S. degree in Chemistry, Pharmacy or Engineering related field.


  • 3+?years Pharmaceutical CMC focused regulatory experience with most of the world filing emphasis.


  • Global experience preferred.


  • Should have experience conducting regulatory assessments, submission authoring and assembly using CTD structure, and eCTD lifecycle management.


  • Proven organizational skills and excellent written/verbal communication are required.


  • Applicant should have demonstrated writing skills, attention to detail and problem solving skills.


  • Proficiency needed in MS Office programs (Word, Excel, Outlook).



EEO Employer


Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.


 

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