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Regulatory Specialist

3 months ago

North Chicago, United States SPECTRAFORCE Full time

Job title : CMC Regulatory Specialist [Must have Authoring Document Exp of Module III]

Location: 100% Remote

Duration:12 months


Strong working knowledge of manufacturing unit operations or CTD structure

2. Experience project managing marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents

3. Experience working with electronic document management systems

4. Superior oral and written communication skills

5. Ability to work independently under pressure and manage multiple projects simultaneously


Education required for the role:

Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline.

Required Experience: 4 years pharmaceutical or industry related experience.

1-2 years in quality systems or cross functional project management


Business need for management of CMC and Device Post Approval Changes and Agency responses for product portfolio.


Manages/directs the activities and people associated with small to large scale projects with a focus on any or several non-IT business applications and disciplines. Manage/direct all facets of single or multiple, multidimensional, mission-critical projects through the Full Project Life Cycle. Collaborate/work with project sponsors, business units and users to identify project scope and focus, develop or monitor project initiatives, implement project requirements/plans/processes/tools, assign/guide/monitor project staff, and assure project success. Deliver quality project solutions to business problems or issues within defined budgets and/or timelines. Provide expert project guidance/support proactively through project completion. Provide tracking, reporting, and presentation to management and users.


Experience Level = 1-3 Years