Regulatory Affairs Associate

Proclinical is currently recruiting for a Regulatory Affairs Associate with a biopharmaceutical company located in North Chicago, IL.

Job Responsibilities:

• With manager support, manages/provides operational oversight to ensure timely, high quality regulatory submissions. Participate in the development of project plans using established templates.
• Plans and negotiates publishing timelines with the teams.
• Effectively manages multiple projects and competing priorities.
• Acts as primary Submission Operations interface with project teams providing guidance and communication of established submission processes and standards.
• Plans and conducts submission team meetings.
• Communicates effectively verbally and in writing with diverse audiences and across various levels within the organization.
• Participates in the development of optimal business processes and practices within the department to ensure high levels of customer support and to achieve high quality submissions.
• Demonstrates submission team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
• Some supervision of projects and assistance with priority setting requires.
• Receives project assignments from manager but has responsibility for managing own projects.
• Reviews project progress with manager on a regular basis with direction provided on follow-up.
• Identifies opportunities for process improvements. May participate on internal project teams to update business processes.

Skills and Requirements:

• Bachelor's degree.
• Years of experience may also compensate for lower education.
• 4 years pharmaceutical or industry related experience.
• Experience working in a complex and matrix environment
• Strong communication skills both oral and written.
• Preferred qualifications include PMP and RAC certificates, experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area, experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred.

If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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