Regulatory Affairs Cmc Jobs in Iowa

Develop and manage day-to-day operations using project management and planning tools, create and maintain detailed project timelines

Support delivery in performing project management activities or as an individual contributor for a deliverable, managing relationships with all stakeholders

Sound understanding of regulatory information management concepts and tools needed to perform regulatory operations priorities in support of all business areas

Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements

There is a travel requirement of up to 10%

Knowledge of IND/NDA/BLA submissions and life cycle submissions for the US market

Assist departmental management in providing regulatory guidance to other departments (QA, QC, Manufacturing, Technical Services, etc.) for planned changes.

Position functions autonomously and consults with departmental management on an as-needed basis.

Position is remote, but expected to be a normal office situation occurring during typical US business hours.

Key responsibilities for this role include:

The minimum qualifications for this role are:

Access – Providing high quality trusted medicines regardless of geography or circumstance;

Deep knowledge of the relevant Regulatory requirements

Opportunity for international career development: a global network offering seminars and training sessions, expert and manager career paths

8+ years relevant experience within the Regulatory Affairs discipline

Ability to develop innovative strategies and creative solutions within the Regulatory context and within the scope of requirements/available resources.

Proven analytical skill and technical/scientific competence.

Strong initiation and organizational skills