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Network CMC Specialist - III/ CMC Manager

Company:
LanceSoft INC
Location:
Rahway, New Jersey, United States
Posted:
November 23, 2016
Description:

Qualifications:

BA/ BS in chemistry, pharmacy, biology, minimum 3-5 years pharmaceutical CMC regulatory experience with post approval emphasis. Global experience preferred. Applicant should have experience conducting regulatory assessments, submission authoring, response to Health Authority questions. Proven organizational skills, attention to detail and problem solving skills. Proficiency in MS Office programs and ability to use other databases as needed.

Responsibilities:

CMC Manager – Identify, obtain, compile, review regulatory documents for global regulatory submissions. Prepare and/or update regulatory submissions e.g. Module 2.3 and Module 3. Assess change proposals, determine regulatory requirements and strategy. Enter information into TrackWise system. Execute post approval filing strategies and variations for global products while ensuring that all regulatory documents are prepared accurately, completely and on time. Track and effectively communicate progress against timelines. Applicant will be responsible for multiple project assignments with critical timelines. Note: This needs to be a hands-on, detail oriented person.